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    Dr Reddy’s Glycemic Happiness Awareness initiative sets Guinness World Record

    23 Aug 2024

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    Dr. Reddy's, Aurigene, And Kainomyx Announce Potential Malaria Drug Partnership

    20 Aug 2024

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    Dr Reddy's gets EIR from USFDA for Visakhapatnam units

    12 Aug 2024

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    Dr. Reddy

    DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.

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    8-2-337, Road No. 3, Banjara Hills, Hyderabad, Telangana-500 034
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    Product List 2024

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    API Product List 2024

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    Products Under Development 2024

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    GMP Certificate 2024

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    DATA COMPILATION #PharmaFlow

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    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    During the first half (H1) of 2024, the global contract development and manufacturing organization (CDMO) landscape was driven by the escalating demand for complex drug development and manufacturing.With the industry grappling with constantly evolving therapeutic modalities, CDMOs are racing to invest in cutting-edge technologies and infrastructure to meet the growing needs of pharmaceutical and biotech companies.Some of the key players in the CDMO space are Catalent, EUROAPI, Lonza, Axplora, Thermo Fisher, SEQENS, Samsung Biologics, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Famar, LGM Pharma, Veranova, and Evonik.View CDMO Activity Tracker for H1 2024 (Free Excel Available) Novo’s parent buys Catalent for US$ 16.5 bn; Bora, Lonza, Siegfried expand US footprintDuring H1 2024, several European and Asian drugmakers expanded their footprints in the US. In February, Novo Nordisk’s parent company, the Novo Nordisk Foundation, announced the acquisition of Catalent through its investment arm Novo Holdings for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. The deal is expected to allow the Danish drugmaker “to serve significantly more people living with diabetes and obesity,” a company statement said.Taiwan-headquartered Bora Pharmaceuticals forged ahead with its expansion plans in the US market by acquiring Minnesota-based generics manufacturer Upsher-Smith Laboratories. Emergent BioSolutions said it is selling its Maryland facility to an affiliate of Bora. This site in Camden is part of its CDMO, Emergent Bioservices, and offers clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services.Swiss drugmaker Lonza has agreed to acquire Genentech’s manufacturing facility in California, US, from Roche for US$ 1.2 billion in cash. The site, located in the city of Vacaville, is one of the largest biologics manufacturing facilities in the world by volume.Lonza also launched an artificial intelligence-driven route design technology for choosing the optimal synthetic pathway to manufacture novel APIs.Switzerland’s Siegfried is acquiring a Wisconsin (US)-based CDMO that specializes in early-phase development and manufacturing services from Curia Global to strengthen its capabilities in North America. Siegfried will further develop the site into its North American Siegfried Acceleration Hub for early-phase CDMO services.View CDMO Activity Tracker for H1 2024 (Free Excel Available)  Merck Millipore, SK Bioscience lead CGT boom; Fujifilm, Axplora, expand CDMO capabilitiesThe burgeoning field of cell and gene therapies (CGTs) is driving significant investments in CDMOs. CGTs saw considerable deal-making too. Merck KGaA agreed to buy Wisconsin-based Mirus Bio for US$ 600 million. Mirus Bio is a specialist in the development and commercialization of transfection reagents that are used to help introduce genetic material into cells. These reagents play a key role in the production of viral vectors for CGTs.Similarly, South Korea’s SK Bioscience acquired a 60 percent stake in IDT Biologika GmbH for KRW 339 billion (US$ 244 million). IDT Biologika is a 104-year-old German company that ranks among the top 10 vaccine producers in the world.CDMOs are also expanding their capabilities in order to lead innovation for their pharmaceutical partners. Fujifilm Diosynth Biotechnologies is investing US$ 1.2 billion in its large-scale cell culture CDMO business to further expand its end-to-end bio-manufacturing facility in North Carolina, bringing the total investment in the facility to over US$ 3.2 billion. Similarly, Merck KGaA owned MilliporeSigma made its biggest investment in the Asia-Pacific region in March when it invested € 300 million (US$ 327 million) in a new bioprocessing production center in Daejeon, South Korea.German CDMO giant Axplora is investing € 8 million (US$ 8.73 million) to expand capacity for antibody drug conjugate (ADC) payload manufacturing at its Le Mans site in France. Catalent completed upgrades to its capsule filling capabilities of dry powders for inhalation to handle potent drugs at its Boston facility. This now positions Catalent as the CDMO with the largest GMP capacity for capsule spray-dried and carrier-based inhaled powders.LGM Pharma increased its Analytical Testing Services (ATS) by 50 percent with a US$ 2 million investment and introduced new suppository manufacturing capabilities to its CDMO portfolio. Minakem has invested in a new production unit in Montreal, Canada, for steroid APIs.View CDMO Activity Tracker for H1 2024 (Free Excel Available)  EUROAPI kicks off four-year sweeping plan; LegoChem partners Samsung Biologics for ADC programSanofi’s spinoff EUROAPI marked 2024 as a “transition year”, setting in motion its Focus-27 plan for profitable growth in the future. The sweeping four-year plan includes a streamlined value-added portfolio focused on highly differentiated and profitable APIs, and a CDMO focused on late-stage and high-value complex small molecules and tides supported by unique technological platforms. The leading French small molecules player signed a five-year collaboration with Ireland’s Priothera wherein EUROAPI will develop and industrialize the manufacturing process of an innovative, complex molecule for blood cancers – mocravimod. The project will be carried out at EUROAPI’s site in Budapest, which is its center of excellence for complex chemistry.South Korea’s CDMO powerhouse Samsung Biologics has partnered LegoChem Biosciences and will provide antibody development and drug substance manufacturing services as a part of LegoChem’s ADC program designed to treat solid tumors. LegoChem aims to submit an investigational new drug application to the US Food and Drug Administration (FDA) in the first half of 2025. Aurigene and Vipergen have joined forces to offer DNA-encoded library (DEL) screening for drug discovery. By combining Aurigene’s drug discovery capabilities with Vipergen’s DEL screening technologies, they seek to create a powerful tool that can quickly test over a billion small-molecule compounds against different disease targets. Dr. Reddy’s Laboratories’ company Aurigene also inaugurated its biologics facility spread across 70,000 square feet.Chinese biotech startup Pleryon is collaborating with France’s SEQENS, a leader in specialty ingredients, to develop and manufacture the former’s lead candidate, an innovative polymer to treat osteoarthritis. Famar is collaborating with Lavipharm and will serve as the contract manufacturer for the latter’s recently added analgesic pharmaceutical products — Lonarid N and Lonalgal.View CDMO Activity Tracker for H1 2024 (Free Excel Available)  Our view Key trends observed in H1 2024 include a surge in investments for fill-finish facilities, a growing emphasis on cell and gene therapies, and advancements in ADC manufacturing. With the proliferation of these new classes of drugs, the CDMO space has been rapidly changing in recent years. In the future, the integration of digital technologies, such as AI and automation, will be a key differentiator for CDMOs looking to optimize their operations and accelerate drug development timelines. 
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    #PharmaFlow by PHARMACOMPASS
    08 Aug 2024
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    DMF submissions from China jump 42% as India continues to top list in Q1 2024

    DMF submissions from China jump 42% as India continues to top list in Q1 2024

    Generic drugs play a crucial role in providing access to life-saving drugs at affordable prices. To that end, drugmakers submit Drug Master Files (DMFs) or their ‘recipes for making generics’ to the US Food and Drug Administration (FDA) for review. Of these, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs.PharmaCompass has been reviewing Type II submissions for several years now. We have noticed that these filings have been increasing in recent years. There has been a 33.5 percent increase in Type II DMF submissions since Q1 2018 (when 176 Type II DMFs had been submitted). However, at 235, the first quarter (Q1) of 2024 saw only a 1.3 percent increase in DMF submissions over Q1 2023. In Q1 2023, DMF submissions had increased by 21.5 percent (over Q1 2022).Of the 235 Type II submissions received by the FDA in Q1 of this year, only 35 (or around 15 percent) had their review completed under the Generic Drug User Fee Act (GDUFA). The total number of reviews completed by the US federal agency so far this year is 129.In all, FDA received 353 Type II, III, IV, and V DMF submissions, compared to 291 in Q1 2023, an increase of 21.3 percent.View FDA DMF Filings in Q1 2024 (Power BI Dashboard, Free Excel Available)DMF submissions from India dip 1.8%; China witnesses 42% rise in filings As has been the trend, India (dubbed as the pharmacy of the world) and China filed the maximum DMF submissions, with 107 and 101 submissions respectively. However, DMFs filed by Indian companies saw a marginal dip of 1.8 percent in Q1 2024 — in Q1 2023, Indian companies had filed 109 Type II DMFs. Meanwhile, DMF filings by Chinese drugmakers increased 42.2 percent in Q1 2024, up from 71 in Q1 2023.India’s MSN Laboratories was the clear leader with 15 DMF submissions to the FDA, while China’s Sichuan Elixir Pharmaceutical came a distant second with nine submissions. Indian drugmakers Aurobindo Pharma and Global Calcium (with seven submissions each) were tied at third position. There were two players at the fifth spot — India’s Dr. Reddy’s Laboratories and China’s Zhejiang Jingsheng Pharmaceutical — as both these drugmakers registered six submissions each.View FDA DMF Filings in Q1 2024 (Power BI Dashboard, Free Excel Available) Diabetes, cancer drugs emerge as hot molecules in Q1 2024Approved in June 2020, triheptanoin is the first and only FDA-approved treatment for children and adults with long-chain fatty acid oxidation disorders (LC-FAOD). At five, triheptanoin saw the maximum DMF filings. Four of those applications have already been positively reviewed.Anti-diabetic drug sitagliptin phosphate monohydrate saw four DMF filings. Empagliflozin, the API found in Boehringer Ingelheim and Eli Lilly’s diabetes drug Jardiance, drew three DMF filings in Q1 2024.In the US, Jazz Pharmaceuticals’ Zepzelca (lurbinectedin) is indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC). Three DMF applications were submitted for lurbinectedin. Similarly, ruxolitinib phosphate, used for the treatment of patients with intermediate or high-risk myelofibrosis, also received three DMF applications.Semaglutide — the glucagon-like peptide-1 receptor agonist that catapulted Novo Nordisk to the position of the most valuable public company in Europe — received three DMF filings. Semaglutide’s arch rival, tirzepatide, also drew three DMF filings.AstraZeneca’s Brilinta (ticagrelor) plus aspirin is currently approved in over 115 countries for the prevention of stroke, heart attack, and other events in adults with acute coronary syndrome (ACS). Ticagrelor received three DMF submissions. Vonoprazan fumarate, a first-in-class potassium-competitive acid blocker to treat acid-related diseases, also received three DMF submissions.View FDA DMF Filings in Q1 2024 (Power BI Dashboard, Free Excel Available) Eighteen DMFs filed for first time in Q1 2024 During the first quarter of this year, 14 drugs saw first time filing of DMFs. Together, these 14 drugs attracted 18 DMF filings with tirzepatide topping the list with three submissions from Chinese companies.The 14 drugs that saw first time filing were clascoterone, capmatinib hydrochloride, niraparib tosylate monohydrate, vibegron, cabozantinib sulfate, ruxolitinib hemifumarate, ripretinib, ruxolitinib, ruxolitinib mesylate, tucatinib hemiethanolate, tecovirimat, tirzepatide, tolvaptan povidone, and azilsartan.View FDA DMF Filings in Q1 2024 (Power BI Dashboard, Free Excel Available) Our viewUntil 2020, DMF submissions by Indian companies used to be double those of Chinese and American firms put together. In 2022, DMF filings from India began to dip, while submissions by Chinese companies began to rise. In the first half of 2023, there was a 46.5 percent rise in DMF submissions from China. The gap between DMF filings by India and China has narrowed down considerably this year. The reasons behind this phenomenon may be multiple. But it definitely implies that America will find it increasingly difficult to reduce its reliance on China.
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    Dr Reddy’s Glycemic Happiness Awareness initiative sets Guinness World Record
    Dr Reddy’s Glycemic Happiness Awareness initiative sets Guinness World Record

    23 Aug 2024

    // EXPRESSPHARMA

    https://www.expresspharma.in/dr-reddys-glycemic-happiness-awareness-initiative-sets-guinness-world-record/

    EXPRESSPHARMA
    23 Aug 2024
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    Dr. Reddy's, Aurigene, And Kainomyx Announce Potential Malaria Drug Partnership
    Dr. Reddy's, Aurigene, And Kainomyx Announce Potential Malaria Drug Partnership

    20 Aug 2024

    // PRESS RELEASE

    https://www.aurigeneservices.com/sites/default/files/2024-08/Media%20note-%20DRL-APSL%20partnership%20with%20Kainomyx.pdf

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    20 Aug 2024
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    Dr Reddy's gets EIR from USFDA for Visakhapatnam units
    Dr Reddy's gets EIR from USFDA for Visakhapatnam units

    12 Aug 2024

    // ECONOMICTIMES

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/dr-reddys-gets-establishment-inspection-report-from-usfda-for-visakhapatnam-units/articleshow/112457452.cms

    ECONOMICTIMES
    12 Aug 2024
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    Dr. Reddy lab`s Generics Prednisone Receives Tentative Approval in US
    Dr. Reddy lab`s Generics Prednisone Receives Tentative Approval in US

    08 Aug 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218035

    FDA
    08 Aug 2024
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    Dr Reddy's invests Rs 734 crore in JV with Nestle India
    Dr Reddy's invests Rs 734 crore in JV with Nestle India

    04 Aug 2024

    // ECONOMICTIMES

    https://health.economictimes.indiatimes.com/news/pharma/pharma-industry/dr-reddys-invests-rs-734-crore-in-jv-with-nestle-india/112258381?utm_source=category_listing&utm_medium=sectionListing

    ECONOMICTIMES
    04 Aug 2024
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    India's MedPlus Health posts Q1 profit surge on strong organised sector growth
    India's MedPlus Health posts Q1 profit surge on strong organised sector growth

    02 Aug 2024

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/indias-medplus-health-posts-q1-profit-surge-strong-organised-sector-growth-2024-08-02/

    REUTERS
    02 Aug 2024
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    ALL APIs

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    Atorvastatin

    India

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    Booth #24A41
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-02-27

    Pay. Date : 2013-02-05

    DMF Number : 18468

    Submission : 2005-06-29

    Status : Active

    Type : II

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    Certificate Number : R0-CEP 2020-092 - Rev 02

    Issue Date : 2023-06-02

    Type : Chemical

    Substance Number : 2191

    Status : Valid

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    Registration Number : 304MF10140

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2022-10-05

    Latest Date of Registration :

    EU-WCarrow-down
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    Date of Issue : 2022-06-15

    Valid Till : 2025-06-16

    Written Confirmation Number : WC-0034

    Address of the Firm : Chemical Technical Operations-Unit II, Plot Nos. 1, 75A, 75B, 105, 110, 111 & 112, Sri Venkateswara Co-operative Industrial Estate,Bollaram (V), Jinn

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    Registrant Name : Hwail Pharmaceutical Co., Ltd.

    Registration Date : 2024-05-01

    Registration Number : 20230331-132-H-410-49(1)

    Manufacturer Name : Dr.Reddy's Laboratories Limited

    Manufacturer Address : CTO-SEZ Process Unit-01 Sector No’s. 28 to 34, 36 to 37, 40, 50 to 53 & 03, Survey No's. 57 to 58, 60, 72 to 73, 76 to 77 & 80, Devunipalavalasa Village, Ranasthalam Mandal, Srikakulam District-532409, Andhra Pradesh, India

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    02

    Cetirizine Dihydrochloride

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-06-16

    Pay. Date : 2014-06-06

    DMF Number : 18395

    Submission : 2005-05-27

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2009-206 - Rev 03

    Issue Date : 2020-01-08

    Type : Chemical

    Substance Number : 1084

    Status : Valid

     JDMF arrow-down
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    Registration Number : 218MF10306

    Registrant's Address : 8-2-337, Road No. 3,Banjara Hills,Hyderabad 500 034,TELANGANA,INDIA

    Initial Date of Registration : 2006-04-20

    Latest Date of Registration :

    EU-WCarrow-down
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    Date of Issue : 2022-06-06

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0039

    Address of the Firm : Unit-I, Plot Nos.137, 138, 145 & 146, Sri Venkateswara Co- Operative Industrial Estate, Bollaram (V), Jinnaram (M), Sngreddy (Dist.), Telangana State, India

     NDC arrow-down
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    NDC Package Code : 71796-013

    Start Marketing Date : 2005-05-27

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Farmirae Co., Ltd.

    Registration Date : 2022-09-16

    Registration Number : 20050831-40-C-145-06(4)

    Manufacturer Name : Dr. Reddy's Laboratories Limited

    Manufacturer Address : Plot No. 137 & 138, 145 & 146, Sri Venkateswara Co-operative industrial estate,Bollaram, Jinnaram Mandal, Sangareddy District, Telangana state, INDIA

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    03

    Clopidogrel

    India

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-30

    Pay. Date : 2013-01-04

    DMF Number : 16090

    Submission : 2002-08-07

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R0-CEP 2021-052 - Rev 01

    Issue Date : 2023-02-20

    Type : Chemical

    Substance Number : 2531

    Status : Valid

     JDMF arrow-down
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    Registration Number : 304MF10059

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2022-03-30

    Latest Date of Registration :

    EU-WCarrow-down
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    Date of Issue : 2022-06-06

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0039

    Address of the Firm : Unit-I, Plot Nos.137, 138, 145 & 146, Sri Venkateswara Co- Operative Industrial Estate, Bollaram (V), Jinnaram (M), Sngreddy (Dist.), Telangana State, India

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    NDC Package Code : 55111-946

    Start Marketing Date : 2011-10-03

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Huseed Co., Ltd.

    Registration Date : 2023-02-13

    Registration Number : 20110225-129-H-88-15(15)

    Manufacturer Name : Dr. Reddy's Laboratories Limited

    Manufacturer Address : CTO - Unit-I, Plot Nos. 137,138,145 & 146, SV Co-Op, Industrial Estate, Bollaram Village, Jinnaram Mandal, Sangareddy District, Telangana - 502 325, INDIA

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    04

    Fexofenadine Hydrochloride

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Booth #24A41
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2020-12-12

    Pay. Date : 2020-12-04

    DMF Number : 15757

    Submission : 2001-12-05

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R0-CEP 2021-067 - Rev 00

    Issue Date : 2023-07-06

    Type : Chemical

    Substance Number : 2280

    Status : Valid

     JDMF arrow-down
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    Registration Number : 302MF10124

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2020-10-05

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-06-04

    Written Confirmation Number : WC-0043Amended

    Address of the Firm : Chemical Technical Operations - Unit V, Peddadevulapally Village, Tripuraram Mandai,Nalgonda District, Telangana

     NDC arrow-down
    ✖

    NDC Package Code : 71796-015

    Start Marketing Date : 2020-03-12

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Sangjin Trading Co., Ltd.

    Registration Date : 2022-10-06

    Registration Number : 20221006-209-J-1373

    Manufacturer Name : Dr. Reddy's Laboratories Ltd.

    Manufacturer Address : Peddadevulapalli Village, Tripuraram Mandal, Nalgonda District, Telangana State, India - 508207

     VMF BR, EU arrow-down
    ✖
    Available Reg. Filing : BR, EU
    AUDIT
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    Market
    Place

    05

    Finasteride

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16010

    Submission : 2002-06-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2009-195 - Rev 03

    Issue Date : 2023-07-12

    Type : Chemical

    Substance Number : 1615

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 226MF10054

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2014-03-06

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-15

    Valid Till : 2025-06-16

    Written Confirmation Number : WC-0034

    Address of the Firm : Chemical Technical Operations-Unit II, Plot Nos. 1, 75A, 75B, 105, 110, 111 & 112, Sri Venkateswara Co-operative Industrial Estate,Bollaram (V), Jinn

     NDC KDMF arrow-down
    ✖

    Registrant Name : Sangjin Trading Co., Ltd.

    Registration Date : 2008-11-28

    Registration Number : 20081128-94-E-29-06

    Manufacturer Name : Dr. Reddy's Laboratories Ltd.,

    Manufacturer Address : Plot No. 110 & 111, SVCo.operative Industrial Estate, Bollaram Village, _x000D_ Jinnaram Mandal, Medak District, Telangana State

     VMF BR, CA, ... arrow-down
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    Available Reg. Filing : BR, CA, RU
    AUDIT
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    Market
    Place

    06

    Gemcitabine

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-06-27

    Pay. Date : 2016-06-06

    DMF Number : 18857

    Submission : 2005-10-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-075 - Rev 06

    Issue Date : 2021-06-18

    Type : Chemical

    Substance Number : 2306

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 220MF10243

    Registrant's Address : 8-2-337, Road No. 3,Banjara Hills,Hyderabad 500 034,TELANGANA,INDIA

    Initial Date of Registration : 2008-12-04

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-06

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0039

    Address of the Firm : Unit-I, Plot Nos.137, 138, 145 & 146, Sri Venkateswara Co- Operative Industrial Estate, Bollaram (V), Jinnaram (M), Sngreddy (Dist.), Telangana State, India

     NDC KDMF arrow-down
    ✖

    Registrant Name : Korea United Pharmaceutical Co., Ltd.

    Registration Date : 2012-05-18

    Registration Number : 20070928-86-D-51-03(3)

    Manufacturer Name : Dr. Reddy's Laboratories Limited

    Manufacturer Address : CTO - Unit-I, Plot Nos. 137,138,145 & 146, SV Co-Op, Industrial Estate, Bollaram Village, Jinnaram Mandal, Sangareddy District, Telangana - 502 325, INDIA

     VMF BR, CA, ... arrow-down
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    Available Reg. Filing : BR, CA, RU
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    Market
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    07

    Levetiracetam

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-30

    Pay. Date : 2013-01-02

    DMF Number : 16966

    Submission : 2003-11-17

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2011-084 - Rev 01

    Issue Date : 2018-05-16

    Type : Chemical

    Substance Number : 2535

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 302MF10034

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2020-03-09

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-04

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0067A4-5

    Address of the Firm : Chemical Technical Operations Unit-VI, APIIC Industrial Estate, Pydibhimavaram Village, Ranasthalam Mandal, Srikakulam District, AP-532409, Andhra Pradesh , India

     NDC arrow-down
    ✖

    NDC Package Code : 55111-870

    Start Marketing Date : 2003-11-17

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Sangjin Trading Co., Ltd.

    Registration Date : 2021-02-17

    Registration Number : 20210217-183-I-616-29

    Manufacturer Name : Dr. Reddy's Laboratories Limited

    Manufacturer Address : CTO Unit-VI, APIIC Industrial Estate, Pydibhimavaram Village, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh - 532 409, India

     VMF BR, CA arrow-down
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    Available Reg. Filing : BR, CA
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    Market
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    08

    Nizatidine

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-09-04

    Pay. Date : 2013-08-23

    DMF Number : 14036

    Submission : 1999-03-16

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2002-027 - Rev 06

    Issue Date : 2023-04-24

    Type : Chemical

    Substance Number : 1453

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10215

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2006-02-16

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-17

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0067n

    Address of the Firm : Chemical Technical Operations Unit-VI, APIIC Industrial Estate, Pydibhimavaram Village, Ranasthalam Mandal, Srikakulam District, AP-532409, Andhra Pradesh , India

     NDC arrow-down
    ✖

    NDC Package Code : 55111-011

    Start Marketing Date : 2012-07-13

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Bahnsen Co., Ltd.

    Registration Date : 2021-05-28

    Registration Number : 20121220-144-I-186-02(14)

    Manufacturer Name : Dr. Reddy's Laboratories Limited

    Manufacturer Address : APIIC Industrial Estate, Pydibhimavaram, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh, India

     VMF Others AUDIT
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    09

    Ondansetron Hydrochloride

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-09-23

    Pay. Date : 2015-09-09

    DMF Number : 15436

    Submission : 2001-05-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2005-071 - Rev 06

    Issue Date : 2023-05-23

    Type : Chemical

    Substance Number : 2016

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 302MF10019

    Registrant's Address : 8-2-337, Road No. 3,Banjara Hills,Hyderabad 500 034,TELANGANA,INDIA

    Initial Date of Registration : 2020-01-31

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-06-04

    Written Confirmation Number : WC-0043Amended

    Address of the Firm : Chemical Technical Operations - Unit V, Peddadevulapally Village, Tripuraram Mandai,Nalgonda District, Telangana

     NDC arrow-down
    ✖

    NDC Package Code : 55111-017

    Start Marketing Date : 2010-01-01

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF BR, EU, ... arrow-down
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    Available Reg. Filing : BR, EU, CA
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    10

    Rabeprazole

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Booth #24A41
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16747

    Submission : 2003-08-04

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2020-382 - Rev 00

    Issue Date : 2021-03-19

    Type : Chemical

    Substance Number : 2331

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 303MF10057

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2021-04-02

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-06

    Valid Till : 2025-06-25

    Written Confirmation Number : WC-0035a

    Address of the Firm : Chemical Technical Operations Unit-V, Plot No 116, Sri Venkateshwara, Jinnaram Mandal, Telangana

     NDC arrow-down
    ✖

    NDC Package Code : 55111-055

    Start Marketing Date : 2010-01-30

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF BR, EU, ... arrow-down
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    Available Reg. Filing : BR, EU, CA, RU
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    USDMF

    read-more
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    01

    Abiraterone Acetate

    India
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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    GDUFA

    DMF Review : Complete

    Rev. Date : 2014-08-13

    Pay. Date : 2014-05-05

    DMF Number : 28038

    Submission : 2014-03-27

    Status : Active

    Type : II

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    Market
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    02

    Amlodipine Besilate Usp

    India
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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-05-21

    Pay. Date : 2013-05-10

    DMF Number : 16473

    Submission : 2003-03-19

    Status : Active

    Type : II

    Dr Reddy Company Banner

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    Market
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    03

    Apalutamide

    India
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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    GDUFA

    DMF Review : Complete

    Rev. Date : 2020-10-28

    Pay. Date : 2020-09-30

    DMF Number : 34667

    Submission : 2020-03-24

    Status : Active

    Type : II

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    04

    Apalutamide (amorphous)

    India
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    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35740

    Submission : 2021-03-25

    Status : Active

    Type : II

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    05

    Apixaban

    India
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    CPhI Worldwide, Milan
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    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    GDUFA

    DMF Review : Complete

    Rev. Date : 2016-03-11

    Pay. Date : 2015-09-30

    DMF Number : 29707

    Submission : 2015-09-22

    Status : Active

    Type : II

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    Market
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    06

    Apremilast (form B)

    India
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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    GDUFA

    DMF Review : Complete

    Rev. Date : 2017-01-05

    Pay. Date : 2016-11-15

    DMF Number : 30732

    Submission : 2016-09-30

    Status : Active

    Type : II

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    07

    Apremilast [amorphous]

    India
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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    GDUFA

    DMF Review : Complete

    Rev. Date : 2017-10-02

    Pay. Date : 2017-08-29

    DMF Number : 31356

    Submission : 2017-06-02

    Status : Active

    Type : II

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    08

    Atomoxetine Hydrochloride Usp

    India
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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18440

    Submission : 2005-06-22

    Status : Active

    Type : II

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    09

    Atorvastatin Calcium (amorphous)

    India
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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-02-27

    Pay. Date : 2013-02-05

    DMF Number : 18468

    Submission : 2005-06-29

    Status : Active

    Type : II

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    10

    Atorvastatin Calcium (butylated Hydr...

    India
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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 25902

    Submission : 2012-03-23

    Status : Active

    Type : II

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    CEP/COS

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    01

    Amlodipine besilate

    India
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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    Certificate Numbers : R1-CEP 2003-007 - Rev 06

    Status : Valid

    Issue Date : 2017-08-23

    Type : Chemical

    Substance Number : 1491

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    02

    Atorvastatin calcium, Form I, ATN proces...

    India
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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    Certificate Numbers : R0-CEP 2020-092 - Rev 02

    Status : Valid

    Issue Date : 2023-06-02

    Type : Chemical

    Substance Number : 2191

    Dr Reddy Company Banner

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    Market
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    03

    Atorvastatin calcium, Form-I

    India
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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    Certificate Numbers : CEP 2011-222 - Rev 02

    Status : Valid

    Issue Date : 2023-09-11

    Type : Chemical

    Substance Number : 2191

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    04

    Capecitabine

    India
    arrow
    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    Certificate Numbers : R1-CEP 2014-109 - Rev 02

    Status : Valid

    Issue Date : 2022-09-13

    Type : Chemical

    Substance Number : 2762

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    05

    Capecitabine

    India
    arrow
    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    Certificate Numbers : R1-CEP 2014-203 - Rev 00

    Status : Valid

    Issue Date : 2020-05-07

    Type : Chemical

    Substance Number : 2762

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    06

    Cetirizine dihydrochloride

    India
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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    Certificate Numbers : R1-CEP 2003-049 - Rev 07

    Status : Valid

    Issue Date : 2018-10-01

    Type : Chemical

    Substance Number : 1084

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    Market
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    07

    Cetirizine dihydrochloride, Process II

    India
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    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    Certificate Numbers : R1-CEP 2009-206 - Rev 03

    Status : Valid

    Issue Date : 2020-01-08

    Type : Chemical

    Substance Number : 1084

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    Market
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    08

    Clopidogrel hydrogen sulfate, Form II

    India
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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
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    Dr. Reddy\\\'s Laboratories

    Certificate Numbers : R0-CEP 2021-052 - Rev 01

    Status : Valid

    Issue Date : 2023-02-20

    Type : Chemical

    Substance Number : 2531

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    09

    Clopidogrel hydrogen sulfate, Form-I

    India
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    Dr. Reddy\\\'s Laboratories

    Certificate Numbers : R1-CEP 2012-059 - Rev 02

    Status : Valid

    Issue Date : 2022-09-27

    Type : Chemical

    Substance Number : 2531

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    10

    Desloratadine

    India
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    Dr. Reddy\\\'s Laboratories

    Certificate Numbers : CEP 2014-321 - Rev 02

    Status : Valid

    Issue Date : 2024-01-25

    Type : Chemical

    Substance Number : 2570

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    Abiraterone Acetate

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    Dr. Reddy\\\'s Laboratories

    Registration Number : 303MF10054

    Registrant's Address : Km. 4.5 Carretera Federal Cuernavaca-Cuautla 62578 Jiutepec, Morelos, Mexico

    Initial Date of Registration : 2021-03-30

    Latest Date of Registration : 2021-03-30

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    02

    Amlodipine besylate

    India
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    Dr. Reddy\\\'s Laboratories

    Registration Number : 219MF10352

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2007-12-10

    Latest Date of Registration : 2009-10-13

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    03

    ATORVA STATN CALCIUM HYDRATE

    India
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    Dr. Reddy\\\'s Laboratories

    Registration Number : 304MF10140

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2022-10-05

    Latest Date of Registration : 2022-10-05

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    04

    Atorvastatin Calcium Hydrate

    India
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    Dr. Reddy\\\'s Laboratories

    Registration Number : 228MF10199

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2016-10-19

    Latest Date of Registration : 2016-10-19

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    05

    ATORVASTATIN CALCIUM TRIHYDRATE FORM-1

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    Dr. Reddy\\\'s Laboratories

    Registration Number : 226MF10020

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2014-01-21

    Latest Date of Registration : 2014-01-21

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    06

    Azacitidine

    India
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    Dr. Reddy\\\'s Laboratories

    Registration Number : 302MF10075

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2020-07-01

    Latest Date of Registration : 2020-07-01

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    07

    Capecitabine

    India
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    Dr. Reddy\\\'s Laboratories

    Registration Number : 304MF10153

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2022-12-07

    Latest Date of Registration : 2022-12-07

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    08

    CETIRIZINE DIHYDROCHLORIDE EP

    India
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    Dr. Reddy\\\'s Laboratories

    Registration Number : 218MF10306

    Registrant's Address : 8-2-337, Road No. 3,Banjara Hills,Hyderabad 500 034,TELANGANA,INDIA

    Initial Date of Registration : 2006-04-20

    Latest Date of Registration : 2006-12-18

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    09

    CLOPIDOGREL SULFATE FORM-I

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    Dr. Reddy\\\'s Laboratories

    Registration Number : 304MF10059

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2022-03-30

    Latest Date of Registration : 2022-03-30

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    10

    CLOPIDOGREL SULPHATE FORM-II

    India
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    Dr. Reddy\\\'s Laboratories

    Registration Number : 303MF10053

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2021-03-26

    Latest Date of Registration : 2021-03-26

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    Apalutamide IH

    India
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    • fda
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    Dr. Reddy\\\'s Laboratories

    Date of Issue : 2022-07-28

    Valid Till : 2025-11-30

    Written Confirmation Number : WC-0390

    Address of the Firm : CTO-SEZ-Process Unit-01, Secto...

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    02

    Apixaban IH

    India
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    Dr. Reddy\\\'s Laboratories

    Date of Issue : 2022-07-28

    Valid Till : 2025-11-30

    Written Confirmation Number : WC-0390

    Address of the Firm : CTO-SEZ-Process Unit-01, Secto...

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    03

    Apremilast IH

    India
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    Dr. Reddy\\\'s Laboratories

    Date of Issue : 2022-09-30

    Valid Till : 2025-11-30

    Written Confirmation Number : WC-390A4

    Address of the Firm : CTO-SEZ Process Unit -01,\\\\r...

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    04

    Atomoxetine Hydrochloride IH

    India
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    Dr. Reddy\\\'s Laboratories

    Date of Issue : 2022-07-28

    Valid Till : 2025-11-30

    Written Confirmation Number : WC-0390

    Address of the Firm : CTO-SEZ-Process Unit-01, Secto...

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    05

    Atomoxetine Hydrochloride IH

    India
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    Dr. Reddy\\\'s Laboratories

    Date of Issue : 2022-06-06

    Valid Till : 2025-06-25

    Written Confirmation Number : WC-0035a

    Address of the Firm : Chemical Technical Operations ...

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    06

    Atomoxetine Hydrochloride IH

    India
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    Dr. Reddy\\\'s Laboratories

    Date of Issue : 2022-06-15

    Valid Till : 2025-06-25

    Written Confirmation Number : WC-0035A3

    Address of the Firm : Chemical Technical Operations ...

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    07

    Atorvastatin Calcium Trihydr...

    India
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    Dr. Reddy\\\'s Laboratories

    Date of Issue : 2022-06-15

    Valid Till : 2025-06-16

    Written Confirmation Number : WC-0034

    Address of the Firm : Chemical Technical Operations...

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    08

    Azacitidine (IH)

    India
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    Dr. Reddy\\\'s Laboratories

    Date of Issue : 2022-06-06

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0039

    Address of the Firm : Unit-I, Plot Nos.137, 138, 145...

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    09

    Bortezomib (IH)

    India
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    Dr. Reddy\\\'s Laboratories

    Date of Issue : 2022-06-06

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0039

    Address of the Firm : Unit-I, Plot Nos.137, 138, 145...

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    10

    Cabazitaxel IH

    India
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    Dr. Reddy\\\'s Laboratories

    Date of Issue : 2022-06-13

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0067A3-A4

    Address of the Firm : Chemical Technical Operations ...

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    amlodipine besylate

    India
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    Dr. Reddy\\\'s Laboratories

    Registrant Name : Sangjin Trading Co., Ltd.

    Registration Date : 2011-04-14

    Registration Number : 20110414-130-H-86-20

    Manufacturer Name : Dr. Reddy's Laboratories Limit...

    Manufacturer Address : Unit-III, Plot No. 116, Sri Venkateswara Co-operative Industrial Estate, IDA Bollaram...

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    02

    amlodipine besylate

    India
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    Dr. Reddy\\\'s Laboratories

    Registrant Name : Pharmapia Co., Ltd.

    Registration Date : 2013-08-28

    Registration Number : 20110414-130-H-86-20(10)

    Manufacturer Name : Dr. Reddy's Laboratories Limit...

    Manufacturer Address : Unit-III, Plot No. 116, Sri Venkateswara Co-operative Industrial Estate, IDA Bollaram...

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    03

    amlodipine besylate

    India
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    Dr. Reddy\\\'s Laboratories

    Registrant Name : Leeyeon Pharmaceutical Co., Ltd.

    Registration Date : 2011-06-30

    Registration Number : 20110414-130-H-86-20(3)

    Manufacturer Name : Dr. Reddy's Laboratories Limit...

    Manufacturer Address : Unit-III, Plot No. 116, Sri Venkateswara Co-operative Industrial Estate, IDA Bollaram...

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    04

    amlodipine besylate

    India
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    Dr. Reddy\\\'s Laboratories

    Registrant Name : Hwail Pharmaceutical Co., Ltd.

    Registration Date : 2011-10-07

    Registration Number : 20110414-130-H-86-20(7)

    Manufacturer Name : Dr. Reddy's Laboratories Limit...

    Manufacturer Address : Unit-III, Plot No. 116, Sri Venkateswara Co-operative Industrial Estate, IDA Bollaram...

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    05

    amlodipine besylate

    India
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    CPhI Worldwide, Milan
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    Dr. Reddy\\\'s Laboratories

    Registrant Name : Chong Kun Dang Co., Ltd.

    Registration Date : 2011-09-30

    Registration Number : 20110414-130-H-86-20(6)

    Manufacturer Name : Dr. Reddy's Laboratories Limit...

    Manufacturer Address : Unit-III, Plot No. 116, Sri Venkateswara Co-operative Industrial Estate, IDA Bollaram...

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    06

    amlodipine besylate

    India
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    Dr. Reddy\\\'s Laboratories

    Registrant Name : Anguk Pharmaceutical Co., Ltd.

    Registration Date : 2011-06-15

    Registration Number : 20110414-130-H-86-20(1)

    Manufacturer Name : Dr. Reddy's Laboratories Limit...

    Manufacturer Address : Unit-III, Plot No. 116, Sri Venkateswara Co-operative Industrial Estate, IDA Bollaram...

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    07

    amlodipine besylate

    India
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    Dr. Reddy\\\'s Laboratories

    Registrant Name : Daesin Pharmaceutical Co., Ltd.

    Registration Date : 2012-09-18

    Registration Number : 20110414-130-H-86-20(9)

    Manufacturer Name : Dr. Reddy's Laboratories Ltd.

    Manufacturer Address : Unit-III, Plot No. 116, Sri Venkateswara Co-operative Industrial Estate, IDA Bollaram...

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    08

    amlodipine besylate

    India
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    Dr. Reddy\\\'s Laboratories

    Registrant Name : Daewoong Pharmaceutical Co., Ltd.

    Registration Date : 2012-03-02

    Registration Number : 20110414-130-H-86-20(8)

    Manufacturer Name : Dr. Reddy's Laboratories Limit...

    Manufacturer Address : Unit-III, Plot No. 116, Sri Venkateswara Co-operative Industrial Estate, IDA Bollaram...

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    09

    amlodipine besylate

    India
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    Dr. Reddy\\\'s Laboratories

    Registrant Name : Youngjin Pharmaceutical Co., Ltd.

    Registration Date : 2011-08-19

    Registration Number : 20110414-130-H-86-20(5)

    Manufacturer Name : Dr. Reddy's Laboratories Limit...

    Manufacturer Address : Unit-III, Plot No. 116, Sri Venkateswara Co-operative Industrial Estate, IDA Bollaram...

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    10

    amlodipine besylate

    India
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    CPhI Worldwide, Milan
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    Dr. Reddy\\\'s Laboratories

    Registrant Name : Boryeong Co., Ltd.

    Registration Date : 2016-01-04

    Registration Number : 20110414-130-H-86-20(11)

    Manufacturer Name : Dr. Reddy's Laboratories Limit...

    Manufacturer Address : Unit-III, Plot No. 116, Sri Venkateswara Co-operative Industrial Estate, IDA Bollaram...

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    01

    ABIRATERONE ACETATE

    India
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    Booth #24A41
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    Dr. Reddy\\\'s Laboratories

    NDC Package Code : 30007-838

    Start Marketing Date : 2010-01-01

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    02

    AMLODIPINE BESYLATE

    India
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    Dr. Reddy\\\'s Laboratories

    NDC Package Code : 55111-025

    Start Marketing Date : 2003-03-19

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    03

    APALUTAMIDE

    India
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    NDC Package Code : 71796-033

    Start Marketing Date : 2021-03-25

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    04

    APALUTAMIDE

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    Dr. Reddy\\\'s Laboratories

    NDC Package Code : 71796-019

    Start Marketing Date : 2020-03-24

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    05

    APIXABAN

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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    NDC Package Code : 55111-980

    Start Marketing Date : 2015-10-23

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    06

    APREMILAST

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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    NDC Package Code : 55111-993

    Start Marketing Date : 2017-06-01

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    07

    APREMILAST

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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    NDC Package Code : 55111-988

    Start Marketing Date : 2017-12-25

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    08

    ATOMOXETINE HYDROCHLORIDE

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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    NDC Package Code : 55111-071

    Start Marketing Date : 2005-06-22

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    09

    BEMPEDOIC ACID

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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    NDC Package Code : 71796-049

    Start Marketing Date : 2022-03-31

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    10

    BENDAMUSTINE HYDROCHLORIDE

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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    NDC Package Code : 55111-938

    Start Marketing Date : 2011-03-30

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Abiraterone Acetate

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    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK &...
    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.
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    01

    Abiraterone Acetate

    India
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    Booth #24A41
    • fda
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.

    About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provide...

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    Acalabrutinib

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    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK &...
    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.
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    02

    Acalabrutinib

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    Booth #24A41
    • fda
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.

    About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provide...

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    Adagrasib

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    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK &...
    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.
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    03

    Adagrasib

    India
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    Booth #24A41
    • fda
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.

    About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provide...

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    Amlodipine Besylate

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    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK &...
    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.
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    04

    Amlodipine Besylate

    India
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    Booth #24A41
    • fda
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.

    About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provide...

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    Apalutamide

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    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK &...
    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.
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    05

    Apalutamide

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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.

    About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provide...

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    Apixaban

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    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK &...
    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.
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    06

    Apixaban

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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.

    About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provide...

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    Apremilast

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    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK &...
    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.
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    Apremilast

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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy\\\'s Laboratories

    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.

    About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provide...

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    Atomoxetin Hydrochloride

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    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK &...
    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.
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    Atomoxetin Hydrochloride

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    Dr. Reddy\\\'s Laboratories

    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.

    About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provide...

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    Atorvastatin

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    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK &...
    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.
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    Atorvastatin

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    Dr. Reddy\\\'s Laboratories

    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.

    About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provide...

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    Azacitidine

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    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK &...
    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.
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    Azacitidine

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    Dr. Reddy\\\'s Laboratories

    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.

    About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provide...

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    Drugs in Development

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    Dr. Reddy's Signs Patent Licensing Agreement with Takeda to Commercialize Vonoprazan (26825 D)

    Details:

    Under the terms of this agreement, Takeda has granted Reddy non-exclusive patent licensing rights for the commercialization of Voquezna (vonoprazan) in India.


    Lead Product(s): Vonoprazan Fumarate

    Therapeutic Area: Gastroenterology Product Name: Vault

    Highest Development Status: Product Type: Small molecule

    Recipient: Takeda Pharmaceutical

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement July 19, 2024

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    Dr. Reddy\\\'s Laboratories

    India
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    Lead Product(s) : Vonoprazan Fumarate

    Therapeutic Area : Gastroenterology

    Highest Development Status :

    Recipient : Takeda Pharmaceutical

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Dr. Reddy's Signs Patent Licensing Agreement with Takeda to Commercialize Vonoprazan (26825 D)

    Details : Under the terms of this agreement, Takeda has granted Reddy non-exclusive patent licensing rights for the commercialization of Voquezna (vonoprazan) in India.

    Product Name : Vault

    Product Type : Small molecule

    Upfront Cash : Undisclosed

    July 19, 2024

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    Zydus and Dr Reddy's Co-Market Pertuzumab Biosimilar (26650 D)

    Details:

    Under the terms of this agreement, Dr. Reddy will receive semi-exclusive rights of Sigrima (pertuzumab) biosimilar of Perjeta from Zydus to co-market the product in India.


    Lead Product(s): Pertuzumab

    Therapeutic Area: Oncology Product Name: Sigrima

    Highest Development Status: ApprovedProduct Type: Large molecule

    Recipient: Zydus Lifesciences

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement June 29, 2024

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    Dr. Reddy\\\'s Laboratories

    India
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    Booth #24A41
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    Lead Product(s) : Pertuzumab

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Recipient : Zydus Lifesciences

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Zydus and Dr Reddy's Co-Market Pertuzumab Biosimilar (26650 D)

    Details : Under the terms of this agreement, Dr. Reddy will receive semi-exclusive rights of Sigrima (pertuzumab) biosimilar of Perjeta from Zydus to co-market the product in India.

    Product Name : Sigrima

    Product Type : Large molecule

    Upfront Cash : Undisclosed

    June 29, 2024

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    Zydus and Dr. Reddy’s License Agreement for Co-Marketing Pertuzumab Biosimilar in India (26572 D)

    Details:

    Through the license agreement, Dr. Reddy’s will receive semi-exclusive rights from Zydus to co-market Womab (pertuzumab) in India for the treatment of HER2-positive breast neoplasms.


    Lead Product(s): Pertuzumab

    Therapeutic Area: Oncology Product Name: Womab

    Highest Development Status: ApprovedProduct Type: Large molecule

    Recipient: Zydus Lifesciences

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement June 28, 2024

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    Dr. Reddy\\\'s Laboratories

    India
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    Lead Product(s) : Pertuzumab

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Recipient : Zydus Lifesciences

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

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    Zydus and Dr. Reddy’s License Agreement for Co-Marketing Pertuzumab Biosimilar in India (26572 D...

    Details : Through the license agreement, Dr. Reddy’s will receive semi-exclusive rights from Zydus to co-market Womab (pertuzumab) in India for the treatment of HER2-positive breast neoplasms.

    Product Name : Womab

    Product Type : Large molecule

    Upfront Cash : Undisclosed

    June 28, 2024

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    Dr. Reddy's Acquire Nicotinell and Related Portfolio (26438 D)

    Details:

    Through the acquisition, Reddy will leverage the NRT portfolio, which includes Nicotinell (nicotine) in various formats such as lozenges, patches, and gum, across all applicable global market.


    Lead Product(s): Nicotine

    Therapeutic Area: Psychiatry/Psychology Product Name: Nicotinell

    Highest Development Status: DiscoveryProduct Type: Small molecule

    Recipient: Haleon

    Deal Size: $632.9 million Upfront Cash: $579.8 million

    Deal Type: Acquisition June 26, 2024

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    Dr. Reddy\\\'s Laboratories

    India
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    Lead Product(s) : Nicotine

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Discovery

    Recipient : Haleon

    Deal Size : $632.9 million

    Deal Type : Acquisition

    DEALS_DEV arrow-down

    Dr. Reddy's Acquire Nicotinell and Related Portfolio (26438 D)

    Details : Through the acquisition, Reddy will leverage the NRT portfolio, which includes Nicotinell (nicotine) in various formats such as lozenges, patches, and gum, across all applicable global market.

    Product Name : Nicotinell

    Product Type : Small molecule

    Upfront Cash : $579.8 million

    June 26, 2024

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    Dr Reddy's Signs In-Licensing Pact with Ingenus for Cancer Treatment Injection (26348 D)

    Details:

    Under the in-licensing pact, Dr Reddy's USA will commercialise the Cyclophosphamide injection, an alkylating drug indicated for treatment of malignant lymphomas, for the US market.


    Lead Product(s): Cyclophosphamide

    Therapeutic Area: Oncology Product Name: Cyclophosphamide-Generic

    Highest Development Status: ApprovedProduct Type: Small molecule

    Recipient: Ingenus Pharmaceuticals

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement June 12, 2024

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    Dr. Reddy\\\'s Laboratories

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    Lead Product(s) : Cyclophosphamide

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Recipient : Ingenus Pharmaceuticals

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Dr Reddy's Signs In-Licensing Pact with Ingenus for Cancer Treatment Injection (26348 D)

    Details : Under the in-licensing pact, Dr Reddy's USA will commercialise the Cyclophosphamide injection, an alkylating drug indicated for treatment of malignant lymphomas, for the US market.

    Product Name : Cyclophosphamide-Generic

    Product Type : Small molecule

    Upfront Cash : Undisclosed

    June 12, 2024

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    Dr. Reddy’s and Novartis sign distribution agreement for anti-diabetes products (26153 D)

    Details:

    Novartis Pharma will be responsible for the supply of Galvus and Galvus Met to DRL. Galvus and Galvus Met are prominent assets in the Dipeptidyl Peptidase-4 (DPP4) inhibitor category.


    Lead Product(s): Vildagliptin

    Therapeutic Area: Endocrinology Product Name: Galvus

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement May 27, 2024

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    Dr. Reddy\\\'s Laboratories

    India
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    Lead Product(s) : Vildagliptin

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Novartis Pharmaceuticals Corporation

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Dr. Reddy’s and Novartis sign distribution agreement for anti-diabetes products (26153 D)

    Details : Novartis Pharma will be responsible for the supply of Galvus and Galvus Met to DRL. Galvus and Galvus Met are prominent assets in the Dipeptidyl Peptidase-4 (DPP4) inhibitor category.

    Product Name : Galvus

    Product Type : Small molecule

    Upfront Cash : Undisclosed

    May 27, 2024

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    Alvotech, Dr. Reddy's Collaborate on Denosumab Biosimilar in US, EU, UK (26049 D)

    Details:

    The collaboration aims for commercialization of AVT03 (denosumab), a monoclonal antibody and a biosimilar to Prolia & Xgeva. It is a RANK ligand inhibitor, being evaluated in bone loss in adult men.


    Lead Product(s): Denosumab

    Therapeutic Area: Musculoskeletal Product Name: AVT03

    Highest Development Status: Phase IProduct Type: Large molecule

    Recipient: Alvotech

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration May 21, 2024

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    Dr. Reddy\\\'s Laboratories

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    Lead Product(s) : Denosumab

    Therapeutic Area : Musculoskeletal

    Highest Development Status : Phase I

    Recipient : Alvotech

    Deal Size : Undisclosed

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Alvotech, Dr. Reddy's Collaborate on Denosumab Biosimilar in US, EU, UK (26049 D)

    Details : The collaboration aims for commercialization of AVT03 (denosumab), a monoclonal antibody and a biosimilar to Prolia & Xgeva. It is a RANK ligand inhibitor, being evaluated in bone loss in adult men.

    Product Name : AVT03

    Product Type : Large molecule

    Upfront Cash : Undisclosed

    May 21, 2024

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    Dr. Reddy's Laboratories Announces the Launch of Doxycycline Capsules, 40 mg in the U.S. (43270 DU)

    Details:

    Oracea-Generic (doxycycline) is a tetracycline class drug indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.


    Lead Product(s): Doxycycline

    Therapeutic Area: Dermatology Product Name: Oracea-Generic

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 03, 2024

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    Dr. Reddy\\\'s Laboratories

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    Lead Product(s) : Doxycycline

    Therapeutic Area : Dermatology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Dr. Reddy's Laboratories Announces the Launch of Doxycycline Capsules, 40 mg in the U.S. (43270 DU...

    Details : Oracea-Generic (doxycycline) is a tetracycline class drug indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.

    Product Name : Oracea-Generic

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    May 03, 2024

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    Nestlé India and Dr. Reddy’s to Form Joint Venture to Take Health Science Nutraceutical Portfolio to Consumers Across India and Other Agreed Territor...

    Details:

    Through the agreement, the two companies will establish a joint venture aimed at introducing innovative nutraceutical brands to consumers. The Nestlé Group will license brands like Nature's Bounty (biotin), an approved nutritional supplement for hair, skin, and nails.


    Lead Product(s): Biotin,Keratin

    Therapeutic Area: Nutrition and Weight Loss Product Name: Nature’s Bounty

    Highest Development Status: ApprovedProduct Type: Small molecule

    Recipient: Nestlé India Limited

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement April 25, 2024

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    Dr. Reddy\\\'s Laboratories

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    Lead Product(s) : Biotin,Keratin

    Therapeutic Area : Nutrition and Weight Loss

    Highest Development Status : Approved

    Recipient : Nestlé India Limited

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Nestlé India and Dr. Reddy’s to Form Joint Venture to Take Health Science Nutraceutical Portfol...

    Details : Through the agreement, the two companies will establish a joint venture aimed at introducing innovative nutraceutical brands to consumers. The Nestlé Group will license brands like Nature's Bounty (biotin), an...

    Product Name : Nature’s Bounty

    Product Type : Small molecule

    Upfront Cash : Undisclosed

    April 25, 2024

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    SEC Recommends Approval to Dr Reddy's to Import and Market Anti-cancer Drug Toripalimab (42960 DU)

    Details:

    Loqtorzi (toripalimab-tpzi) is an anti-PD-1 monoclonal antibody, which is an approved product in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma.


    Lead Product(s): Toripalimab,Cisplatin,Gemcitabine

    Therapeutic Area: Oncology Product Name: Loqtorzi

    Highest Development Status: Phase IIIProduct Type: Large molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 18, 2024

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    Dr. Reddy\\\'s Laboratories

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    Lead Product(s) : Toripalimab,Cisplatin,Gemcitabine

    Therapeutic Area : Oncology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    SEC Recommends Approval to Dr Reddy's to Import and Market Anti-cancer Drug Toripalimab (42960 DU)

    Details : Loqtorzi (toripalimab-tpzi) is an anti-PD-1 monoclonal antibody, which is an approved product in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent lo...

    Product Name : Loqtorzi

    Product Type : Large molecule

    Upfront Cash : Not Applicable

    April 18, 2024

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    01

    Brand Name : N/A

    India
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    Regulatory Info : Lead Market Dossiers- Filed

    Registration Country : India

    Abiraterone Acetate

    Dr. Reddy\\\'s Laboratories

    Dosage Form : Oral Solid Dosage Form

    Brand Name :

    Dosage Strength : 500MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Lead Market Dossiers- Filed

    Registration Country : India

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    Brand Name : N/A

    India
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    Regulatory Info : Lead Market Dossiers- Approved in US

    Registration Country : India

    Abiraterone Acetate

    Dr. Reddy\\\'s Laboratories

    Dosage Form : Tablet

    Brand Name :

    Dosage Strength : 250MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Lead Market Dossiers- Approved in US

    Registration Country : India

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    Brand Name : ABIRATERONE ACETATE

    India
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    Regulatory Info : RX

    Registration Country : USA

    ABIRATERONE ACETATE

    Dr. Reddy\\\'s Laboratories

    Dosage Form : TABLET;ORAL

    Brand Name : ABIRATERONE ACETATE

    Dosage Strength : 500MG

    Packaging :

    Approval Date : 2023-09-01

    Application Number : 208416

    Regulatory Info : RX

    Registration Country : USA

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    04

    Brand Name : N/A

    India
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    Regulatory Info : Lead Market Dossiers- Filed

    Registration Country : India

    Abiraterone Acetate

    Dr. Reddy\\\'s Laboratories

    Dosage Form : Oral Solid Dosage Form

    Brand Name :

    Dosage Strength : 250MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Lead Market Dossiers- Filed

    Registration Country : India

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    Brand Name : ABIRATERONE ACETATE

    India
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    Regulatory Info : RX

    Registration Country : USA

    ABIRATERONE ACETATE

    Dr. Reddy\\\'s Laboratories

    Dosage Form : TABLET;ORAL

    Brand Name : ABIRATERONE ACETATE

    Dosage Strength : 250MG

    Packaging :

    Approval Date : 2020-05-18

    Application Number : 208416

    Regulatory Info : RX

    Registration Country : USA

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    Brand Name : SECTRAL

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    ACEBUTOLOL HYDROCHLORIDE

    Promius Pharma

    Dosage Form : CAPSULE;ORAL

    Brand Name : SECTRAL

    Dosage Strength : EQ 200MG BASE **Federa...

    Packaging :

    Approval Date : 1984-12-28

    Application Number : 18917

    Regulatory Info : DISCN

    Registration Country : USA

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    Brand Name : SECTRAL

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    ACEBUTOLOL HYDROCHLORIDE

    Promius Pharma

    Dosage Form : CAPSULE;ORAL

    Brand Name : SECTRAL

    Dosage Strength : EQ 400MG BASE **Federa...

    Packaging :

    Approval Date : 1984-12-28

    Application Number : 18917

    Regulatory Info : DISCN

    Registration Country : USA

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    Market
    Place

    08

    Brand Name : BUTALBITAL AND ACETA...

    India
    arrow
    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Regulatory Info : RX

    Registration Country : USA

    ACETAMINOPHEN; BUTALBITAL

    Dr. Reddy\\\'s Laboratories

    Dosage Form : CAPSULE;ORAL

    Brand Name : BUTALBITAL AND ACETAMINOP...

    Dosage Strength : 300MG;50MG

    Packaging :

    Approval Date : 2017-12-27

    Application Number : 207313

    Regulatory Info : RX

    Registration Country : USA

    Dr Reddy Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Brand Name : BUTALBITAL, ACETAMIN...

    India
    arrow
    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Regulatory Info : RX

    Registration Country : USA

    ACETAMINOPHEN; BUTALBITAL; CAFFEINE

    Dr. Reddy\\\'s Laboratories

    Dosage Form : CAPSULE;ORAL

    Brand Name : BUTALBITAL, ACETAMINOPHEN...

    Dosage Strength : 300MG;50MG;40MG

    Packaging :

    Approval Date : 2019-12-17

    Application Number : 210817

    Regulatory Info : RX

    Registration Country : USA

    Dr Reddy Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Brand Name : BUTALBITAL, ACETAMIN...

    India
    arrow
    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Regulatory Info : RX

    Registration Country : USA

    ACETAMINOPHEN; BUTALBITAL; CAFFEINE

    Dr. Reddy\\\'s Laboratories

    Dosage Form : CAPSULE;ORAL

    Brand Name : BUTALBITAL, ACETAMINOPHEN...

    Dosage Strength : 325MG;50MG;40MG

    Packaging :

    Approval Date : 1986-03-17

    Application Number : 89007

    Regulatory Info : RX

    Registration Country : USA

    Dr Reddy Company Banner

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    Market
    Place

    Only 10 entries up to this point, click to access all click full view read-more
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    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    FDA Orange Book

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    01

    Brand Name : ABIRATERONE ACETATE

    India
    CPhI Worldwide, Milan
    Booth #24A41
    arrow
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    RLD : No

    TE Code : AB

    ABIRATERONE ACETATE

    Dr. Reddy\\\'s Laboratories

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABIRATERONE ACETATE

    Dosage Strength : 250MG

    Approval Date : 2020-05-18

    Application Number : 208416

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

    Dr Reddy Company Banner

    Product
    Web Link

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    #PipelineProspector

    Market
    Place

    02

    Brand Name : ABIRATERONE ACETATE

    India
    CPhI Worldwide, Milan
    Booth #24A41
    arrow
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    RLD : No

    TE Code : AB

    ABIRATERONE ACETATE

    Dr. Reddy\\\'s Laboratories

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABIRATERONE ACETATE

    Dosage Strength : 500MG

    Approval Date : 2023-09-01

    Application Number : 208416

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

    Dr Reddy Company Banner

    Product
    Web Link

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    Market
    Place

    03

    Brand Name : SECTRAL

    U.S.A
    KY/TN Water Professionals
    Not Confirmed
    arrow
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    RLD : Yes

    TE Code :

    ACEBUTOLOL HYDROCHLORIDE

    Promius Pharma

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : SECTRAL

    Dosage Strength : EQ 200MG BASE **Federal ...

    Approval Date : 1984-12-28

    Application Number : 18917

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

    Dr. Reddy Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    04

    Brand Name : SECTRAL

    U.S.A
    KY/TN Water Professionals
    Not Confirmed
    arrow
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    RLD : Yes

    TE Code :

    ACEBUTOLOL HYDROCHLORIDE

    Promius Pharma

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : SECTRAL

    Dosage Strength : EQ 400MG BASE **Federal ...

    Approval Date : 1984-12-28

    Application Number : 18917

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

    Dr. Reddy Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Brand Name : BUTALBITAL AND ACETA...

    India
    CPhI Worldwide, Milan
    Booth #24A41
    arrow
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    RLD : No

    TE Code : AA

    ACETAMINOPHEN; BUTALBITAL

    Dr. Reddy\\\'s Laboratories

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : BUTALBITAL AND ACETAMINO...

    Dosage Strength : 300MG;50MG

    Approval Date : 2017-12-27

    Application Number : 207313

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AA

    Dr Reddy Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Brand Name : BUTALBITAL, ACETAMIN...

    India
    CPhI Worldwide, Milan
    Booth #24A41
    arrow
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    RLD : No

    TE Code : AA

    ACETAMINOPHEN; BUTALBITAL; CAFFEINE

    Dr. Reddy\\\'s Laboratories

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : BUTALBITAL, ACETAMINOPHE...

    Dosage Strength : 325MG;50MG;40MG

    Approval Date : 1986-03-17

    Application Number : 89007

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AA

    Dr Reddy Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Brand Name : BUTALBITAL, ACETAMIN...

    India
    CPhI Worldwide, Milan
    Booth #24A41
    arrow
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    RLD : No

    TE Code : AA

    ACETAMINOPHEN; BUTALBITAL; CAFFEINE

    Dr. Reddy\\\'s Laboratories

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : BUTALBITAL, ACETAMINOPHE...

    Dosage Strength : 300MG;50MG;40MG

    Approval Date : 2019-12-17

    Application Number : 210817

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AA

    Dr Reddy Company Banner

    Product
    Web Link

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    #PipelineProspector

    Market
    Place

    08

    Brand Name : OXYCODONE AND ACETAM...

    India
    CPhI Worldwide, Milan
    Booth #24A41
    arrow
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    RLD : No

    TE Code :

    ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

    Dr. Reddy\\\'s Laboratories

    Dosage Form : TABLET; ORAL

    Proprietary Name : OXYCODONE AND ACETAMINOP...

    Dosage Strength : 325MG;2.5MG

    Approval Date : 2008-10-20

    Application Number : 90177

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

    Dr Reddy Company Banner

    Product
    Web Link

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    Market
    Place

    09

    Brand Name : OXYCODONE AND ACETAM...

    India
    CPhI Worldwide, Milan
    Booth #24A41
    arrow
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    RLD : No

    TE Code :

    ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

    Dr. Reddy\\\'s Laboratories

    Dosage Form : TABLET; ORAL

    Proprietary Name : OXYCODONE AND ACETAMINOP...

    Dosage Strength : 325MG;5MG

    Approval Date : 2008-10-20

    Application Number : 90177

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

    Dr Reddy Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Brand Name : OXYCODONE AND ACETAM...

    India
    CPhI Worldwide, Milan
    Booth #24A41
    arrow
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    RLD : No

    TE Code :

    ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

    Dr. Reddy\\\'s Laboratories

    Dosage Form : TABLET; ORAL

    Proprietary Name : OXYCODONE AND ACETAMINOP...

    Dosage Strength : 325MG;7.5MG

    Approval Date : 2008-10-20

    Application Number : 90177

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

    Dr Reddy Company Banner

    Product
    Web Link

    Stock Recap
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    Market
    Place

    Only 10 entries up to this point, click to access all click full view read-more
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    Europe

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    01

    Brand Name : AMBRISENTAN DR. REDD...

    India
    arrow
    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Regulatory Info :

    Registration Country : Italy

    Ambrisentan

    Dr. Reddy\\\'s Laboratories

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 10 mg

    Packaging : 30 UNITS 10 MG - O...

    Brand Name : AMBRISENTAN DR. REDDY'S

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

    Dr Reddy Company Banner

    Product
    Web Link

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    #PipelineProspector

    Market
    Place

    02

    Brand Name : AMBRISENTAN DR. REDD...

    India
    arrow
    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Regulatory Info :

    Registration Country : Italy

    Ambrisentan

    Dr. Reddy\\\'s Laboratories

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 5 mg

    Packaging : 30 UNITS 5 MG - OR...

    Brand Name : AMBRISENTAN DR. REDDY'S

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

    Dr Reddy Company Banner

    Product
    Web Link

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    #PipelineProspector

    Market
    Place

    03

    Brand Name : CINACALCET DR REDDY'...

    India
    arrow
    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Regulatory Info :

    Registration Country : Italy

    Cinacalcet

    Dr. Reddy\\\'s Laboratories

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 30 mg

    Packaging : 28 UNITS 30 MG - O...

    Brand Name : CINACALCET DR REDDY'S

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

    Dr Reddy Company Banner

    Product
    Web Link

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    #PipelineProspector

    Market
    Place

    04

    Brand Name : CINACALCET DR REDDY'...

    India
    arrow
    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Regulatory Info :

    Registration Country : Italy

    Cinacalcet

    Dr. Reddy\\\'s Laboratories

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 60 mg

    Packaging : 28 UNITS 60 MG - O...

    Brand Name : CINACALCET DR REDDY'S

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

    Dr Reddy Company Banner

    Product
    Web Link

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    #PipelineProspector

    Market
    Place

    05

    Brand Name : CINACALCET DR REDDY'...

    India
    arrow
    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Regulatory Info :

    Registration Country : Italy

    Cinacalcet

    Dr. Reddy\\\'s Laboratories

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 90 mg

    Packaging : 28 UNITS 90 MG - O...

    Brand Name : CINACALCET DR REDDY'S

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

    Dr Reddy Company Banner

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    Market
    Place

    06

    Brand Name : IMATINIB DR. REDDY'S

    India
    arrow
    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Regulatory Info :

    Registration Country : Italy

    Imatinib

    Dr. Reddy\\\'s Laboratories

    Dosage Form : Hard Capsules

    Dosage Strength : 100 mg

    Packaging : 120 UNITS 100 MG -...

    Brand Name : IMATINIB DR. REDDY'S

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

    Dr Reddy Company Banner

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    Market
    Place

    07

    Brand Name : SILDENAFIL DR. REDDY...

    India
    arrow
    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Regulatory Info :

    Registration Country : Italy

    Sildenafil

    Dr. Reddy\\\'s Laboratories

    Dosage Form : Film-Coated Tablet

    Dosage Strength : 20mg

    Packaging : 90 UNITS 20 MG - O...

    Brand Name : SILDENAFIL DR. REDDY'S

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

    Dr Reddy Company Banner

    Product
    Web Link

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    Market
    Place

    08

    Brand Name : SITAGLIPTIN AND METF...

    India
    arrow
    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Regulatory Info :

    Registration Country : Italy

    Sitagliptin; Metformin

    Dr. Reddy\\\'s Laboratories

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 50 mg/1,000 mg

    Packaging : 56 UNITS (50+1000)...

    Brand Name : SITAGLIPTIN AND METFORMIN DR....

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

    Dr Reddy Company Banner

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    Market
    Place

    09

    Brand Name : SITAGLIPTIN AND METF...

    India
    arrow
    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Regulatory Info :

    Registration Country : Italy

    Sitagliptin; Metformin

    Dr. Reddy\\\'s Laboratories

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 50 mg/850 mg

    Packaging : 56 UNITS (50+850) ...

    Brand Name : SITAGLIPTIN AND METFORMIN DR....

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

    Dr Reddy Company Banner

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    Market
    Place

    10

    Brand Name : TERIFLUNOMIDE DR. RE...

    India
    arrow
    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Regulatory Info :

    Registration Country : Italy

    Teriflunomide

    Dr. Reddy\\\'s Laboratories

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 14 mg

    Packaging : 28 UNITS 14 MG - O...

    Brand Name : TERIFLUNOMIDE DR. REDDY'S

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

    Dr Reddy Company Banner

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    Market
    Place

    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    Listed Dossiers

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    01

    Brand Name : N/A

    India
    arrow
    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Regulatory Info : Lead Market Dossiers- Filed

    Registration Country : India

    Abiraterone Acetate

    Dr. Reddy\\\'s Laboratories

    Dosage Form : Oral Solid Dosage Form

    Brand Name :

    Dosage Strength : 250MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Lead Market Dossiers- Filed

    Registration Country : India

    Dr Reddy Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    Brand Name : N/A

    India
    arrow
    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Regulatory Info : Lead Market Dossiers- Filed

    Registration Country : India

    Abiraterone Acetate

    Dr. Reddy\\\'s Laboratories

    Dosage Form : Oral Solid Dosage Form

    Brand Name :

    Dosage Strength : 500MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Lead Market Dossiers- Filed

    Registration Country : India

    Dr Reddy Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Brand Name : N/A

    India
    arrow
    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Regulatory Info : Lead Market Dossiers- Approved...

    Registration Country : India

    Abiraterone Acetate

    Dr. Reddy\\\'s Laboratories

    Dosage Form : Tablet

    Brand Name :

    Dosage Strength : 250MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Lead Market Dossiers- Approved...

    Registration Country : India

    Dr Reddy Company Banner

    Product
    Web Link

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    Market
    Place

    04

    Brand Name : N/A

    India
    arrow
    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Regulatory Info :

    Registration Country : India

    Ambrisentan

    Dr. Reddy\\\'s Laboratories

    Dosage Form : Tablet

    Brand Name :

    Dosage Strength : 5MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Dr Reddy Company Banner

    Product
    Web Link

    Stock Recap
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    Market
    Place

    05

    Brand Name : N/A

    India
    arrow
    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Regulatory Info :

    Registration Country : India

    Ambrisentan

    Dr. Reddy\\\'s Laboratories

    Dosage Form : Tablet

    Brand Name :

    Dosage Strength : 10MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Dr Reddy Company Banner

    Product
    Web Link

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    Market
    Place

    06

    Brand Name : N/A

    India
    arrow
    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Regulatory Info : Lead Market Dossiers- Under De...

    Registration Country : India

    Amphotericin B

    Dr. Reddy\\\'s Laboratories

    Dosage Form : Injection

    Brand Name :

    Dosage Strength : 50MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Lead Market Dossiers- Under De...

    Registration Country : India

    Dr Reddy Company Banner

    Product
    Web Link

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    #PipelineProspector

    Market
    Place

    07

    Brand Name : N/A

    India
    arrow
    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Regulatory Info : Lead Market Dossiers- Filed

    Registration Country : India

    Apixaban

    Dr. Reddy\\\'s Laboratories

    Dosage Form : Oral Solid Dosage Form

    Brand Name :

    Dosage Strength : 2.5MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Lead Market Dossiers- Filed

    Registration Country : India

    Dr Reddy Company Banner

    Product
    Web Link

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    #PipelineProspector

    Market
    Place

    08

    Brand Name : N/A

    India
    arrow
    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Regulatory Info : Lead Market Dossiers- Filed

    Registration Country : India

    Apixaban

    Dr. Reddy\\\'s Laboratories

    Dosage Form : Oral Solid Dosage Form

    Brand Name :

    Dosage Strength : 5MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Lead Market Dossiers- Filed

    Registration Country : India

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    Brand Name : N/A

    India
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    Booth #24A41
    • fda
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    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Regulatory Info : Lead Market Dossiers- Filed

    Registration Country : India

    Apremilast

    Dr. Reddy\\\'s Laboratories

    Dosage Form : Oral Solid Dosage Form

    Brand Name :

    Dosage Strength : 10MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Lead Market Dossiers- Filed

    Registration Country : India

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    Brand Name : N/A

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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Regulatory Info : Lead Market Dossiers- Filed

    Registration Country : India

    Apremilast

    Dr. Reddy\\\'s Laboratories

    Dosage Form : Oral Solid Dosage Form

    Brand Name :

    Dosage Strength : 20MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Lead Market Dossiers- Filed

    Registration Country : India

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    Market
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    KEY PRODUCTS

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    Excipients

    Discover the DDS // excipients from this company

    All Excipients

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    01

    Salcaprozate Sodium Excipient

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38202

    Submission : 2023-03-31

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Inspections and registrations

    Check the inspections & registration from this company

    FDA

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    01

    FDA Audited

    USA
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    CPhI Worldwide, Milan
    Booth #24A41

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2020-02-28

    Dr. Reddy\\\'s Laboratories

    City : Medchal Malkajgiri Distri...

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2020-02-28

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    02

    FDA Audited

    USA
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    Booth #24A41

    District Decision : No Action Indicated

    Inspection End Date : 2020-02-27

    Dr. Reddy\\\'s Laboratories

    City : Hyderabad

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2020-02-27

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    03

    FDA Audited

    USA
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    Booth #24A41

    District Decision : No Action Indicated

    Inspection End Date : 2020-02-14

    Dr. Reddy\\\'s Laboratories

    City : Ranasthalam Mandal, Srika...

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2020-02-14

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    04

    FDA Audited

    USA
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    Booth #24A41

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2020-01-28

    Dr. Reddy\\\'s Laboratories

    City : Srikakulam District

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2020-01-28

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    05

    FDA Audited

    USA
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    CPhI Worldwide, Milan
    Booth #24A41

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-08-20

    Dr. Reddy\\\'s Laboratories

    City : Duvvada

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-08-20

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    06

    FDA Audited

    USA
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    Booth #24A41

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-10-24

    Dr. Reddy\\\'s Laboratories

    City : Mirfield

    State :

    Country/Area : UK

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-10-24

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    07

    FDA Audited

    USA
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    Booth #24A41

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-07-12

    Dr. Reddy\\\'s Laboratories

    City : Hyderabad

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-07-12

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    08

    FDA Audited

    USA
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    CPhI Worldwide, Milan
    Booth #24A41

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-06-21

    Dr. Reddy\\\'s Laboratories

    City : Duvvada

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDRH

    Project Area : Compliance: Devices

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-06-21

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    09

    FDA Audited

    USA
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    CPhI Worldwide, Milan
    Booth #24A41

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-02-08

    Dr. Reddy\\\'s Laboratories

    City : Medchal Malkajgiri Distri...

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-02-08

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    10

    FDA Audited

    USA
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    Booth #24A41

    District Decision : No Action Indicated

    Inspection End Date : 2019-06-21

    Dr. Reddy\\\'s Laboratories

    City : Duvvada

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2019-06-21

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    EDQM

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    01

    GMP Certified

    EU
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    Booth #24A41

    Dr. Reddy\\\'s Laboratories

    Type : GMP Certificates

    Number : UK MIA(IMP)...

    EudraGMDP Key : 47969

    Country : United Kingdom

    Issue Date : 2018-04-30

    Post Code :

    NCA Ref : 18014-DR RED...

    City : BEVERLEY

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    02

    GMP Certified

    EU
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    Booth #24A41

    Dr. Reddy\\\'s Laboratories

    Type : GMP Certificates

    Number : IT/E/API/12...

    EudraGMDP Key : 47844

    Country : India

    Issue Date : 2018-05-04

    Post Code :

    NCA Ref : 548371525451...

    City : Hyderabad

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    03

    GMP Certified

    EU
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    Booth #24A41

    Dr. Reddy\\\'s Laboratories

    Type : GMP Certificates

    Number : DE_HH_01_GM...

    EudraGMDP Key : 45474

    Country : India

    Issue Date : 2017-12-19

    Post Code :

    NCA Ref : 00026268

    City : INDIA 502 325

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    04

    GMP Certified

    EU
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    Booth #24A41

    Dr. Reddy\\\'s Laboratories

    Type : GMP Certificates

    Number : 032/2016/RO

    EudraGMDP Key : 40918

    Country : India

    Issue Date : 2016-09-30

    Post Code :

    NCA Ref : 466781491481...

    City : Visakhapatnam

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    05

    GMP Certified

    EU
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    Booth #24A41

    Dr. Reddy\\\'s Laboratories

    Type : GMP Certificates

    Number : UK GMP 8512...

    EudraGMDP Key : 37014

    Country : India

    Issue Date : 2016-08-10

    Post Code :

    NCA Ref : 17970-DR RED...

    City : QUTUBULLAPUR MANDAL, RA...

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    06

    GMP Certified

    EU
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    CPhI Worldwide, Milan
    Booth #24A41

    Dr. Reddy\\\'s Laboratories

    Type : GMP Certificates

    Number : DE_BY_04_GM...

    EudraGMDP Key : 37238

    Country : India

    Issue Date : 2016-07-21

    Post Code :

    NCA Ref : 00024315

    City : Andhra Pradesh 530046

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    07

    GMP Certified

    EU
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    CPhI Worldwide, Milan
    Booth #24A41

    Dr. Reddy\\\'s Laboratories

    Type : GMP Certificates

    Number : HMP/PT/35/2...

    EudraGMDP Key : 29861

    Country : India

    Issue Date : 2015-06-23

    Post Code :

    NCA Ref : A0191863144

    City : ANDHRA PRADESH

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    08

    GMP Certified

    EU
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    CPhI Worldwide, Milan
    Booth #24A41

    Dr. Reddy\\\'s Laboratories

    Type : GMP Certificates

    Number : VMP/PT/5/20...

    EudraGMDP Key : 29862

    Country : India

    Issue Date : 2015-06-23

    Post Code :

    NCA Ref : A0191863144

    City : ANDHRA PRADESH

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    09

    GMP Certified

    EU
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    CPhI Worldwide, Milan
    Booth #24A41

    Dr. Reddy\\\'s Laboratories

    Type : GMP Certificates

    Number : DE_BY_04_GM...

    EudraGMDP Key : 23938

    Country : India

    Issue Date : 2014-06-10

    Post Code :

    NCA Ref : 00020840

    City : 530 046 Andhra Pradesh

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    10

    GMP Certified

    EU
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    Booth #24A41

    Dr. Reddy\\\'s Laboratories

    Type : GMP Certificates

    Number : UK API 8512...

    EudraGMDP Key : 4900

    Country : India

    Issue Date : 2010-04-07

    Post Code :

    NCA Ref : 21841-DR RED...

    City : JINNARAM MANDAL, SANGAR...

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    GDUFA

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    01

    GDUFA fees paid

    USA
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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Paid in : 2024

    Dr. Reddy\\\'s Laboratories

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : Dr. Reddy's Laboratories Limit...

    Business Address : Chemical Technical Operation...

    FEI Number : 3005447965

    Country : India

    Paid in : 2024

    Dr Reddy Company Banner

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    02

    GDUFA fees paid

    USA
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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Paid in : 2019

    Dr. Reddy\\\'s Laboratories

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : Dr Reddy's Laboratories Limite...

    Business Address : Plot No. 9/A, Phase III, IDA...

    FEI Number : 3002806664

    Country : India

    Paid in : 2019

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    03

    GDUFA fees paid

    USA
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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Paid in : 2024

    Dr. Reddy\\\'s Laboratories

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : Dr. Reddy's Laboratories (EU) ...

    Business Address : Steanard Lane, Mirfield, Wes...

    FEI Number : 3002807544

    Country : India

    Paid in : 2024

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    04

    GDUFA fees paid

    USA
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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Paid in : 2019

    Dr. Reddy\\\'s Laboratories

    API Manufacturer :

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : Dr. Reddy's Laboratories Inc D...

    Business Address : 201 Industrial Drive Bristol...

    FEI Number : 1047293

    Country : India

    Paid in : 2019

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    05

    GDUFA fees paid

    USA
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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Paid in : 2024

    Dr. Reddy\\\'s Laboratories

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : Dr. Reddy's Laboratories Limit...

    Business Address : Chemical Technical Operation...

    FEI Number : 3002949085

    Country : India

    Paid in : 2024

    Dr Reddy Company Banner

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    06

    GDUFA fees paid

    USA
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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Paid in : 2024

    Dr. Reddy\\\'s Laboratories

    API Manufacturer :

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : DR. REDDY'S LABORATORIES LIMIT...

    Business Address : Formulation Technical Operat...

    FEI Number : 3002949099

    Country : India

    Paid in : 2024

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    07

    GDUFA fees paid

    USA
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    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Paid in : 2024

    Dr. Reddy\\\'s Laboratories

    API Manufacturer :

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : DR. REDDY'S LABORATORIES LIMIT...

    Business Address : Formulation Technical Operat...

    FEI Number : 3006549835

    Country : India

    Paid in : 2024

    Dr Reddy Company Banner

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    08

    GDUFA fees paid

    USA
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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Paid in : 2024

    Dr. Reddy\\\'s Laboratories

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : Dr. Reddy's Laboratories Limit...

    Business Address : Chemical Technical Operation...

    FEI Number : 3002806851

    Country : India

    Paid in : 2024

    Dr Reddy Company Banner

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    09

    GDUFA fees paid

    USA
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    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Paid in : 2024

    Dr. Reddy\\\'s Laboratories

    API Manufacturer :

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : DR. REDDY'S LABORATORIES LIMIT...

    Business Address : FTO-SEZ-Process Unit-01 Surv...

    FEI Number : 3009193040

    Country : India

    Paid in : 2024

    Dr Reddy Company Banner

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    10

    GDUFA fees paid

    USA
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    CPhI Worldwide, Milan
    Booth #24A41
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Paid in : 2024

    Dr. Reddy\\\'s Laboratories

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : Dr. Reddy's Laboratories Limit...

    Business Address : Chemical Technical Operation...

    FEI Number : 3005448030

    Country : India

    Paid in : 2024

    Dr Reddy Company Banner

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    ABOUT THIS PAGE

    Contact Dr. Reddy\\\\\\\'s Laboratories and get a quotation

    Dr. Reddy\\\\\\\'s Laboratories is a supplier offers 182 products (APIs, Excipients or Intermediates).

    Find a price of Atorvastatin bulk with DMF, CEP, JDMF, WC offered by Dr. Reddy\\\\\\\'s Laboratories

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