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    Dr. Reddy’s launches Toripalimab under brand name Zytorvi in India

    30 Nov 2024

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    Senores Pharma Launches Ivermectin Tablets In US With Dr. Reddy’s

    28 Nov 2024

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    Dr. Reddy's & Senores Pharma Launch of Ivermectin US Market

    26 Nov 2024

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    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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    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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    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397  Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17   13 37 Taiwan 9 6 5 4 24 Switzerland 15 4   4 23 France 16     6 22 Japan 18   1   19 United Kingdom 12 1   2 15 Mexico 9 1   1 11 Ireland 5 5   1 11   Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years. 
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    #PharmaFlow by PHARMACOMPASS
    21 Nov 2024
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    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024.  Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent.  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each.  The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders).  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available)    GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453   US$ 3,21,920   Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427   US$ 2,31,952 FDF—Foreign US$ 2,35,427   US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629   US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852   US$ 7,56,666 Small business generic drug applicant US$ 1,72,963   US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.   
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    24 Oct 2024
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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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    08 Aug 2024
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    FDA approves record eight biosimilars in H1 2024; okays first interchangeable biosimilars for Eylea

    FDA approves record eight biosimilars in H1 2024; okays first interchangeable biosimilars for Eylea

    Biologics, or complex drugs that are derived from living organisms, have revolutionized treatment of various conditions such as cancer, autoimmune diseases, and chronic illnesses. In 2023, eight out of 10 of the world’s top-selling drugs were biologics, including Merck’s Keytruda, AbbVie’s Humira, and Sanofi’s Dupixent.Due to their high costs, accessibility of biologics has been a challenge. That’s why biosimilars, or game-changing copycats of biologics that provide highly similar yet more affordable alternatives to established biologics, are becoming popular.The first biosimilar — Sandoz’ Zarxio — was approved by the US Food and Drug Administration (FDA) in 2015. Its reference biologic was Amgen’s Neupogen (filgrastim).  Since then, the global market for biosimilars has been growing at an impressive pace — between 2015 and 2020, it grew at a whopping compounded annual growth rate (CAGR) of 78 percent, touching US$ 17.9 billion in size. It is expected to continue growing at a CAGR of 15 percent and reach a size of about US$ 75 billion by 2030.Major biosimilar players include Amgen, Sandoz, Samsung Bioepis, Pfizer, Biocon Biologics, Celltrion, Stada Arzneimittel, Accord Healthcare, Fresenius Kabi, Coherus Biosciences, Apotex, and Sanofi. The increasing demand for biosimilars has propelled growth in contract manufacturing. Some of the leading contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) that manufacture biosimilars are Polpharma Biologics, Catalent, Pfizer CentreOne, Lonza, Boehringer Ingelheim BioXcellence, Thermo Fisher Scientific, WuXi Biologics, and FUJIFILM Diosynth Biotechnologies.Access the Interactive Dashboard for Biosimilar Developments (Free Excel)Amgen, Sandoz top list of ‘approved biosimilars’; FDA okays 8 copycats in H1 2024Over the recent years, regulatory agencies like the FDA and the European Medicines Agency (EMA) have established rigorous approval pathways for biosimilars.Since 2015,  FDA has approved 53 biosimilars, while the EMA has approved 86 biosimilars. Among the US, European and Canadian markets, Amgen and Sandoz are tied in the first place with 13 approved biosimilars each. Samsung Biologics has nine approved biosimilars, followed by Pfizer with eight and Biocon Biologics with seven. In the first half of this year, FDA set a record by approving eight biosimilars — the highest for H1 of any year. EMA has okayed six biosimilars so far in 2024.In 2023, five biosimilars were approved by the FDA with just one being okayed in the first half. The year marked the end of exclusivity for Humira after 20 years, in which it netted a total of US$ 200 billion in sales. AbbVie’s flagship autoimmune drug has a record 10 biosimilars.Johnson & Johnson’s Stelara also lost exclusivity in 2023 and as many as 11 drugmakers hope to bring its biosimilars to the market. Amgen’s Wezlana was the first biosimilar to Stelara, and it was approved as interchangeable by FDA in October last year.Access the Interactive Dashboard for Biosimilar Developments (Free Excel) FDA approves first interchangeable biosimilar for Eylea, cuts regulatory feeDeveloping a biosimilar costs both money and time. According to Pfizer, developing a biosimilar can take five to nine years and cost over US$ 100 million, not including regulatory fees.In October 2023, FDA slashed its fees with the program fee at US$ 177,397, down from US$ 304,162. The application fees for products that require clinical data has been set at US$ 1,018,753, down from US$ 1,746,745. The application fee for products that don’t require clinical data has been set lower — at US$ 509,377 —  down from US$ 873,373 set earlier. This reduction in application fee has propelled demand for contract manufacturing of biosimilars.There has also been a rise in approvals of interchangeable biosimilars this year. Interchangeable biosimilars meet additional requirements and may be substituted for its reference product by a pharmacist without consulting the prescriber. This year saw FDA approve the first interchangeable biosimilars for bone cancer drug denosumab (Prolia and Xgeva) in Jubbonti and Wyost as well as for eculizumab (Soliris) in Bkemv.In May, FDA approved the first interchangeable biosimilars for eye drug aflibercept (Eylea) in Opuviz and Yesafili. Other biosimilars approved in 2024 include Simlandi for adalimumab (Humira), Tyenne for tocilizumab (Actemra), Selarsdi for ustekinumab (Stelara), and Hercessi for trastuzumab (Herceptin).Access the Interactive Dashboard for Biosimilar Developments (Free Excel) Merck’s Keytruda, BMS’ Opdivo, Novartis’ Cosentyx brace for biosimilar competitionHealthcare spending in the US is projected to rise from US$ 4.5 trillion in 2022 to US$ 6 trillion by 2027. While biologics involve just two percent of prescriptions, they account for 46 percent of all pharmaceutical spending. In 2022, US$ 252 billion was spent on biologics.Biosimilar-related savings in 2023 were estimated to be US$ 9.4 billion in the US and € 10 billion (US$ 10.68 billion) in Europe. With expensive and widely used drugs like AbbVie’s Humira, J&J’s Stelara, and Regeneron’s Eylea coming under competition, US savings are projected to reach US$ 181 billion through 2027. Between 2026 and 2032, about 39 blockbusters are set to lose exclusivity in the US and Europe. Merck’s Keytruda (pembrolizumab) was the world’s top-selling drug last year, generating US$ 25 billion in sales. Its patent is set to expire in 2028 with sales expected to drop 19 percent to US$ 27.4 billion in 2029 from US$ 33.7 billion the previous year. Samsung Bioepis and Amgen initiated phase 3 trials of pembrolizumab in April and May of this year, respectively.Opdivo (nivolumab), belonging to the same class of drugs, competes with Keytruda and is also set to lose patent protection in 2028. It hauled in US$ 10 billion in total global sales in 2023 for Bristol Myers Squibb. The key patents of Novartis’ Cosentyx (secukinumab) are set to expire between 2025 and 2026. Cosentyx saw sales of US$ 5 billion in 2023. Taizhou Mabtech Pharmaceutical and Bio-Thera Solutions are conducting phase 3 trials of secukinumab.Access the Interactive Dashboard for Biosimilar Developments (Free Excel) Our viewWith over 2 billion people worldwide unable to access life-saving medicines, biosimilars hold the key to healthcare accessibility. In 2023, a record 13 biosimilars were launched in the market — the highest for a single year. And this included nine much-anticipated biosimilars to AbbVie’s Humira.  In April this year, FDA announced a Biosimilars Action Plan to streamline the development of biosimilars. With a sharp focus on biosimilars, we expect more records to be broken in the near term. New launches of biosimilars to drugs like J&J’s Stelara, Regeneron’s Eylea and Merck’s Keytruda will surely help in creating new records.
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    Impressions: 2425

    https://www.pharmacompass.com/radio-compass-blog/fda-approves-record-eight-biosimilars-in-h1-2024-okays-first-interchangeable-biosimilars-for-eylea

    #PharmaFlow by PHARMACOMPASS
    27 Jun 2024
    Share Share
    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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    Impressions: 3341

    https://www.pharmacompass.com/radio-compass-blog/dmf-submissions-from-china-jump-42-as-india-continues-to-top-list-in-q1-2024

    #PharmaFlow by PHARMACOMPASS
    23 May 2024
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    NEWS #PharmaBuzz

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    Dr. Reddy’s launches Toripalimab under brand name Zytorvi in India
    Dr. Reddy’s launches Toripalimab under brand name Zytorvi in India

    30 Nov 2024

    // PRESS RELEASE

    https://www.drreddys.com/cms/cms/sites/default/files/2024-11/Dr.%20Reddy%27s%20press%20release%20-%20launch%20of%20Toripalimab%20in%20India.pdf

    PRESS RELEASE
    30 Nov 2024
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    Senores Pharma Launches Ivermectin Tablets In US With Dr. Reddy’s
    Senores Pharma Launches Ivermectin Tablets In US With Dr. Reddy’s

    28 Nov 2024

    // INDPHARMAPOST

    https://www.indianpharmapost.com/news/senores-pharmaceuticals-launches-ivermectin-tablets-in-us-with-dr-reddys-laboratories-16491

    INDPHARMAPOST
    28 Nov 2024
    Share Share
    Dr. Reddy's & Senores Pharma Launch of Ivermectin US Market
    Dr. Reddy's & Senores Pharma Launch of Ivermectin US Market

    26 Nov 2024

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20241126395966/en

    BUSINESSWIRE
    26 Nov 2024
    Share Share
    6 pharma companies sign MoUs with Telangana for Pharma City
    6 pharma companies sign MoUs with Telangana for Pharma City

    23 Nov 2024

    // BUSINESS STD

    https://www.business-standard.com/industry/news/six-pharma-companies-sign-mous-with-telangana-govt-for-pharma-city-124112201333_1.html

    BUSINESS STD
    23 Nov 2024
    Share Share
    Enforcement Report - Week of November 13, 2024
    Enforcement Report - Week of November 13, 2024

    13 Nov 2024

    // FDA

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-november-13-2024-31538.pdf

    FDA
    13 Nov 2024
    Share Share
    Enforcement Report - Week of November 6, 2024
    Enforcement Report - Week of November 6, 2024

    06 Nov 2024

    // FDA

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-november-6-2024-85888.pdf

    FDA
    06 Nov 2024
    Share Share

    ALL APIs

    read-moreClick the button for full data set
    read-moreClick the button for full data set

    01

    Atorvastatin

    India

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
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    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 : Reviewed

    Rev. Date : 2013-02-27

    Pay. Date : 2013-02-05

    DMF Number : 18468

    Submission : 2005-06-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

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

    Issue Date : 2023-06-02

    Type : Chemical

    Substance Number : 2191

    Status : Valid

     JDMF arrow-down
    ✖

    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
    ✖

    Date of Issue : 2022-06-15

    Valid Till : 2025-06-16

    Written Confirmation Number : WC-0034

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    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

     VMF Others AUDIT
    Dr Reddy Company Banner

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    Market
    Place

    02

    Cetirizine Dihydrochloride

    India

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • 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 : 2014-06-16

    Pay. Date : 2014-06-06

    DMF Number : 18395

    Submission : 2005-05-27

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

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

    Issue Date : 2020-01-08

    Type : Chemical

    Substance Number : 1084

    Status : Valid

     JDMF arrow-down
    ✖

    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
    ✖

    Date of Issue : 2022-06-06

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0039

    Address of the Firm :

    NDC arrow-down
    ✖

    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

    KDMF arrow-down
    ✖

    Registrant Name : Pami Future 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

     VMF Others AUDIT
    Dr Reddy Company Banner

    Product
    Web Link

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    Market
    Place

    03

    Clopidogrel

    India

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
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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 : 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
    ✖

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

    Issue Date : 2022-09-27

    Type : Chemical

    Substance Number : 2531

    Status : Valid

     JDMF arrow-down
    ✖

    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
    ✖

    Date of Issue : 2022-06-06

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0039

    Address of the Firm :

    NDC arrow-down
    ✖

    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

    KDMF arrow-down
    ✖

    Registrant Name : Huseeed 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

     VMF Others AUDIT
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    04

    Fexofenadine Hydrochloride

    India

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

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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 : 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
    ✖

    Certificate Number : R0-CEP 2021-067 - Rev 00

    Issue Date : 2023-07-06

    Type : Chemical

    Substance Number : 2280

    Status : Valid

     JDMF arrow-down
    ✖

    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 :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Sangjin Corporation

    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 Others AUDIT
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    Market
    Place

    05

    Finasteride

    India

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • 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 :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Sangjin Corporation

    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 Others AUDIT
    Dr Reddy Company Banner

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    Web Link

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    #PipelineProspector

    Market
    Place

    06

    Gemcitabine

    India

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • 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 :

    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 Others AUDIT
    Dr Reddy Company Banner

    Product
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    Market
    Place

    07

    Levetiracetam

    India

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
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    • 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 : 2022-06-17

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0067

    Address of the Firm :

    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 Corporation

    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 Others AUDIT
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    08

    Nizatidine

    India

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

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    Pharma, Lab & Chemical Expo
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    • fda
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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 : 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-0067

    Address of the Firm :

    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 : Bansen 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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    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 :

    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 Others AUDIT
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    10

    Rabeprazole

    India

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

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    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 2021-023 - Rev 00

    Issue Date : 2023-01-10

    Type : Chemical

    Substance Number : 2868

    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 :

    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 Others AUDIT
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    Abiraterone Acetate

    India
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    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

    Dr Reddy Company Banner

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    02

    Amlodipine Besilate Usp

    India
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    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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    03

    Apalutamide

    India
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    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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    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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    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

    Dr Reddy Company Banner

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    Market
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    06

    Apremilast (form B)

    India
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    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

    Dr Reddy Company Banner

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    07

    Apremilast [amorphous]

    India
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    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

    Dr Reddy Company Banner

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    08

    Atomoxetine Hydrochloride Usp

    India
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    Dr. Reddy's Laboratories

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18440

    Submission : 2005-06-22

    Status : Active

    Type : II

    Dr Reddy Company Banner

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    09

    Atorvastatin Calcium (amorphous)

    India
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    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

    Dr Reddy Company Banner

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    10

    Atorvastatin Calcium (butylated Hydr...

    India
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    Dr. Reddy's Laboratories

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 25902

    Submission : 2012-03-23

    Status : Active

    Type : II

    Dr Reddy Company Banner

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    Amlodipine besilate

    India
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    Dr. Reddy's Laboratories

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

    Status : Valid

    Issue Date : 2017-08-23

    Type : Chemical

    Substance Number : 1491

    Dr Reddy Company Banner

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    02

    Atorvastatin calcium, Form I, ATN proces...

    India
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    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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    03

    Atorvastatin calcium, Form-I

    India
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    Dr. Reddy's Laboratories

    Certificate Numbers : CEP 2011-222 - Rev 02

    Status : Valid

    Issue Date : 2023-09-11

    Type : Chemical

    Substance Number : 2191

    Dr Reddy Company Banner

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    04

    Capecitabine

    India
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    Dr. Reddy's Laboratories

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

    Status : Valid

    Issue Date : 2020-05-07

    Type : Chemical

    Substance Number : 2762

    Dr Reddy Company Banner

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    05

    Capecitabine

    India
    arrow
    Pharma, Lab & Chemical Expo
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    Dr. Reddy's Laboratories

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

    Status : Valid

    Issue Date : 2022-09-13

    Type : Chemical

    Substance Number : 2762

    Dr Reddy Company Banner

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    06

    Cetirizine dihydrochloride

    India
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    Pharma, Lab & Chemical Expo
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    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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    07

    Cetirizine dihydrochloride, Process II

    India
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    Dr. Reddy's Laboratories

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

    Status : Valid

    Issue Date : 2020-01-08

    Type : Chemical

    Substance Number : 1084

    Dr Reddy Company Banner

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    08

    Clopidogrel hydrogen sulfate, Form II

    India
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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

    India
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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

    India
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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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    01

    Abacavir IH

    India
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    Dr. Reddy's Laboratories

    Date of Issue : 2022-06-17

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0067

    Address of the Firm : Chemical Technical Operations ...

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    Agomelatine Phosphoric Acid ...

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    Dr. Reddy's Laboratories

    Date of Issue : 2022-06-17

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0067

    Address of the Firm : Chemical Technical Operations ...

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    Amtolmetin Guacil IH

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    Dr. Reddy's Laboratories

    Date of Issue : 2022-06-17

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0067

    Address of the Firm : Chemical Technical Operations ...

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    Apalutamide IH

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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

    Apixaban IH

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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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    Apremilast IH

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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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    Asenapine Maleate IH

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    Dr. Reddy's Laboratories

    Date of Issue : 2022-06-17

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0067

    Address of the Firm : Chemical Technical Operations ...

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    Atomoxetine Hydrochloride IH

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    Dr. Reddy's Laboratories

    Date of Issue : 2022-07-28

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    Written Confirmation Number : WC-0390

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

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    Atomoxetine Hydrochloride IH

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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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    Atomoxetine Hydrochloride IH

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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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    KDMF

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    Amlodipine besilate

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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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    Amlodipine besilate

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    Dr. Reddy's Laboratories

    Registrant Name : Lee Yeon 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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    Amlodipine besilate

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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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    Amlodipine besilate

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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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    Amlodipine besilate

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    Dr. Reddy's Laboratories

    Registrant Name : Ankuk 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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    Amlodipine besilate

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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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    Amlodipine besilate

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    Dr. Reddy's Laboratories

    Registrant Name : Daeshin 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 besilate

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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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    Amlodipine besilate

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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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    Amlodipine besilate

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    Dr. Reddy's Laboratories

    Registrant Name : Sangjin Corporation

    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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    Drugs in Development

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    Dr. Reddy’s launches Toripalimab under the brand name Zytorvi in India

    Details:

    Zytorvi (toripalimab) is an approved anti-PD-1 monoclonal antibody, in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic nasopharyngeal carcinoma.


    Lead Product(s): Toripalimab,Cisplatin,Gemcitabine

    Therapeutic Area: Oncology Brand Name: Zytorvi

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 28, 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 : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Dr. Reddy’s launches Toripalimab under the brand name Zytorvi in India

    Details : Zytorvi (toripalimab) is an approved anti-PD-1 monoclonal antibody, in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic nasopharyngeal carcinoma.

    Brand Name : Zytorvi

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    November 28, 2024

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    Dr. Reddy's Laboratories and Senores Pharmaceuticals Launch Ivermectin Tablets in US

    Details:

    Stromectol-Generic (ivermectin) is a glutamate-gated chloride channel modulator, small molecule drug candidate, which is indicated for the treatment of patients with strongyloidiasis & onchocerciasis.


    Lead Product(s): Ivermectin

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Stromectol-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Senores Pharmaceuticals

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 26, 2024

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    Dr. Reddy's Laboratories

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    Lead Product(s) : Ivermectin

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Senores Pharmaceuticals

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Dr. Reddy's Laboratories and Senores Pharmaceuticals Launch Ivermectin Tablets in US

    Details : Stromectol-Generic (ivermectin) is a glutamate-gated chloride channel modulator, small molecule drug candidate, which is indicated for the treatment of patients with strongyloidiasis & onchocerciasis.

    Brand Name : Stromectol-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    November 26, 2024

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    Dr Reddy's Launches Medication to Treat Chronic Constipation

    Details:

    Bixibat (elobixibat hydrate) is a bile acid transporter inhibitor, small molecule drug candidate, which is indicated for the treatment of chronic constipation.


    Lead Product(s): Elobixibat Hydrate

    Therapeutic Area: Gastroenterology Brand Name: Bixibat

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 28, 2024

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    03

    Dr. Reddy's Laboratories

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    Lead Product(s) : Elobixibat Hydrate

    Therapeutic Area : Gastroenterology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Dr Reddy's Launches Medication to Treat Chronic Constipation

    Details : Bixibat (elobixibat hydrate) is a bile acid transporter inhibitor, small molecule drug candidate, which is indicated for the treatment of chronic constipation.

    Brand Name : Bixibat

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    October 28, 2024

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    Dr. Reddy’s Partners with Gilead to Manufacture Lenacapavir in India and Beyond

    Details:

    The agreement aims to make and sell generic lenacapavir, subject to required regulatory approvals, in 120 high-incidence, resource-limited countries for HIV prevention.


    Lead Product(s): Lenacapavir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Sunlenca

    Study Phase: Phase IIIProduct Type: Small molecule

    Recipient: Gilead Sciences

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement October 02, 2024

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    Dr. Reddy's Laboratories

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    Lead Product(s) : Lenacapavir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase III

    Recipient : Gilead Sciences

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Dr. Reddy’s Partners with Gilead to Manufacture Lenacapavir in India and Beyond

    Details : The agreement aims to make and sell generic lenacapavir, subject to required regulatory approvals, in 120 high-incidence, resource-limited countries for HIV prevention.

    Brand Name : Sunlenca

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    October 02, 2024

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    Dr. Reddy’s Receives Positive CHMP Opinion from EMA for its Proposed Rituximab Biosimilar

    Details:

    Ituxredi (rituximab) is an anti-CD20 monoclonal antibody, which is indicated for the treatment of non-hodgkin’s lymphoma, chronic lymphocytic leukemia & rheumatoid arthritis.


    Lead Product(s): Rituximab

    Therapeutic Area: Oncology Brand Name: Ituxredi

    Study Phase: Phase IIIProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 29, 2024

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    Dr. Reddy's Laboratories

    India
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    Lead Product(s) : Rituximab

    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

    Dr. Reddy’s Receives Positive CHMP Opinion from EMA for its Proposed Rituximab Biosimilar

    Details : Ituxredi (rituximab) is an anti-CD20 monoclonal antibody, which is indicated for the treatment of non-hodgkin’s lymphoma, chronic lymphocytic leukemia & rheumatoid arthritis.

    Brand Name : Ituxredi

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    July 29, 2024

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    Dr. Reddy's Signs Patent Licensing Agreement with Takeda to Commercialize Vonoprazan

    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 Brand Name: Vault

    Study Phase: ApprovedProduct Type: Small molecule

    Recipient: Takeda Pharmaceutical

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement July 18, 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 : Approved

    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

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

    Brand Name : Vault

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    July 18, 2024

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

    Details:

    Under the agreement, product will be marketed by Zydus under the brand Sigrima while Dr. Reddy’s will market it under brand name Womab used for treatment of Breast Cancer.


    Lead Product(s): Pertuzumab

    Therapeutic Area: Oncology Brand Name: Womab

    Study Phase: 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

    DEALS_DEV arrow-down

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

    Details : Under the agreement, product will be marketed by Zydus under the brand Sigrima while Dr. Reddy’s will market it under brand name Womab used for treatment of Breast Cancer.

    Brand Name : Womab

    Molecule Type : Large molecule

    Upfront Cash : Undisclosed

    June 28, 2024

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    Virtual Booth

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

    Dr. Reddy's Acquire Nicotinell and Related Portfolio

    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 Brand Name: Nicotinell

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

    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

    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.

    Brand Name : Nicotinell

    Molecule Type : Small molecule

    Upfront Cash : $579.8 million

    June 26, 2024

    Dr Reddy Company Banner

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    Virtual Booth

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

    Dr Reddy's Signs In-Licensing Pact with Ingenus for Cancer Treatment Injection

    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 Brand Name: Cyclophosphamide-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Recipient: Ingenus Pharmaceuticals

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement June 12, 2024

    Dr Reddy Company Banner

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    Dr. Reddy's Laboratories

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

    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

    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.

    Brand Name : Cyclophosphamide-Generic

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    June 12, 2024

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    Virtual Booth

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    Dr. Reddy’s and Novartis sign distribution agreement for anti-diabetes products

    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 Brand Name: Galvus

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Novartis Pharmaceuticals Corporation

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement May 27, 2024

    Dr Reddy Company Banner

    10

    Dr. Reddy's Laboratories

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

    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

    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.

    Brand Name : Galvus

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    May 27, 2024

    Dr Reddy Company Banner

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    Virtual Booth

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    FDF Dossiers

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    01

    Brand Name : N/A

    India
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    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

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    02

    Brand Name : ABIRATERONE ACETATE

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

    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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    Market
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    03

    Brand Name : N/A

    India
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    Pharma, Lab & Chemical Expo
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    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

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    04

    Brand Name : ABIRATERONE ACETATE

    India
    arrow
    Pharma, Lab & Chemical Expo
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    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

    Dr Reddy Company Banner

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    05

    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

    Dr Reddy Company Banner

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    06

    Brand Name : SECTRAL

    U.S.A
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    Pharma, Lab & Chemical Expo
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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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    07

    Brand Name : SECTRAL

    U.S.A
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    Pharma, Lab & Chemical Expo
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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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    Market
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    08

    Brand Name : BUTALBITAL AND ACETA...

    India
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    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

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    Market
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    09

    Brand Name : BUTALBITAL, ACETAMIN...

    India
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    Pharma, Lab & Chemical Expo
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    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

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    Market
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    10

    Brand Name : BUTALBITAL, ACETAMIN...

    India
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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    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

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    Market
    Place

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    FDA Orange Book

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    01

    Brand Name : ABIRATERONE ACETATE

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    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

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    02

    Brand Name : ABIRATERONE ACETATE

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    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

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    03

    Brand Name : SECTRAL

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    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

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    04

    Brand Name : SECTRAL

    U.S.A
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    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

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    05

    Brand Name : BUTALBITAL AND ACETA...

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    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

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    Market
    Place

    06

    Brand Name : BUTALBITAL, ACETAMIN...

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    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

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    07

    Brand Name : BUTALBITAL, ACETAMIN...

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    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

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    08

    Brand Name : ACETAMINOPHEN AND IB...

    India
    Pharma, Lab & Chemical Expo
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    RLD : No

    TE Code :

    ACETAMINOPHEN; IBUPROFEN

    Dr. Reddy's Laboratories

    Dosage Form : TABLET; ORAL

    Proprietary Name : ACETAMINOPHEN AND IBUPRO...

    Dosage Strength : 250MG;125MG

    Approval Date : 2024-08-23

    Application Number : 218247

    RX/OTC/DISCN : OTC

    RLD : No

    TE Code :

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    Market
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    09

    Brand Name : OXYCODONE AND ACETAM...

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    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 :

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    10

    Brand Name : OXYCODONE AND ACETAM...

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    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

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    Europe

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    Brand Name : AMBRISENTAN DR. REDD...

    India
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    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

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    02

    Brand Name : AMBRISENTAN DR. REDD...

    India
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    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

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    03

    Brand Name : CINACALCET DR REDDY'...

    India
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    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

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    04

    Brand Name : CINACALCET DR REDDY'...

    India
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    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

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    05

    Brand Name : CINACALCET DR REDDY'...

    India
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    Pharma, Lab & Chemical Expo
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    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

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    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Brand Name : IMATINIB DR. REDDY'S

    India
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    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

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    Brand Name : SILDENAFIL DR. REDDY...

    India
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    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

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    08

    Brand Name : SITAGLIPTIN AND METF...

    India
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    Pharma, Lab & Chemical Expo
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    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

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    09

    Brand Name : SITAGLIPTIN AND METF...

    India
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    Pharma, Lab & Chemical Expo
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    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

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    10

    Brand Name : TERIFLUNOMIDE DR. RE...

    India
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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    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

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    Listed Dossiers

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    01

    Brand Name : N/A

    India
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
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    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

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    Market
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    02

    Brand Name : N/A

    India
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    Pharma, Lab & Chemical Expo
    Not Confirmed
    • 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

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    Market
    Place

    03

    Brand Name : N/A

    India
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
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    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

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    Market
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    04

    Brand Name : N/A

    India
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    Pharma, Lab & Chemical Expo
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    • EDQM
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    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

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    05

    Brand Name : N/A

    India
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    • fda
    • EDQM
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    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

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    Market
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    06

    Brand Name : N/A

    India
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    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
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    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

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    07

    Brand Name : N/A

    India
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    Pharma, Lab & Chemical Expo
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    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

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    08

    Brand Name : N/A

    India
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    Pharma, Lab & Chemical Expo
    Not Confirmed
    • 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

    Dr Reddy Company Banner

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    09

    Brand Name : N/A

    India
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
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    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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    10

    Brand Name : N/A

    India
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    Pharma, Lab & Chemical Expo
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    • 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

    Dr Reddy Company Banner

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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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    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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    Pharma, Lab & Chemical Expo
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-11-10

    Dr. Reddy's Laboratories

    City : Shreveport

    State : Louisiana

    Country/Area : US

    Zip : 71106

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-11-10

    Dr Reddy Company Banner

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    02

    FDA Audited

    USA
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2024-05-17

    Dr. Reddy's Laboratories

    City : Visakhapatnam

    State : -

    Country/Area : IN

    Zip : -

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2024-05-17

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    03

    FDA Audited

    USA
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2024-09-20

    Dr. Reddy's Laboratories

    City : Bachupally

    State : -

    Country/Area : IN

    Zip : -

    District :

    Center :

    Project Area : Bioresearch Monitoring

    District Decision : No Action Indicated

    Inspection End Date : 2024-09-20

    Dr Reddy Company Banner

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    04

    FDA Audited

    USA
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2023-10-27

    Dr. Reddy's Laboratories

    City : Medchal-Malkajgiri Distri...

    State : -

    Country/Area : IN

    Zip : -

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2023-10-27

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    05

    FDA Audited

    USA
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2023-05-12

    Dr. Reddy's Laboratories

    City : Devunipalavalasa

    State : -

    Country/Area : IN

    Zip : -

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2023-05-12

    Dr Reddy Company Banner

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    06

    FDA Audited

    USA
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2023-06-16

    Dr. Reddy's Laboratories

    City : Jinnaram

    State : -

    Country/Area : IN

    Zip : -

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2023-06-16

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    07

    FDA Audited

    USA
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2023-07-19

    Dr. Reddy's Laboratories

    City : Srikakulam

    State : -

    Country/Area : IN

    Zip : -

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2023-07-19

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    08

    FDA Audited

    USA
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2022-05-20

    Dr. Reddy's Laboratories

    City : Srikakulam

    State : -

    Country/Area : IN

    Zip : -

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2022-05-20

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    09

    FDA Audited

    USA
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2022-05-26

    Dr. Reddy's Laboratories

    City : Princeton

    State : New Jersey

    Country/Area : US

    Zip : 08540

    District :

    Center :

    Project Area : Bioresearch Monitoring

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2022-05-26

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    10

    FDA Audited

    USA
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2023-05-05

    Dr. Reddy's Laboratories

    City : Sangareddy, Hyderabad

    State : -

    Country/Area : IN

    Zip : -

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2023-05-05

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    Data Compilation
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    ABOUT THIS PAGE

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

    Dr. Reddy\'s Laboratories is a supplier offers 217 products (APIs, Excipients or Intermediates).

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