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    Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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    About

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertica...
    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.

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    CONTACT DETAILS

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    India
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    7-2-A2, Hetero Corporate Industrial Estates, Sanath Nagar Hyderabad,Telangana
    Telephone
    Telephone
    +91 40 23704923/24
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    enquiries@pharmacompass.com
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    https://www.hetero.com/
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    This week, SpeakPharma interviews Denise Sutton, Chief Operating Officer and Site Head at Quotient Sciences’ Nottingham facility in the UK. Quotient Sciences is a drug development and manufacturing accelerator that offers the innovative Translational Pharmaceutics platform to support customers in overcoming drug development challenges. Sutton has been with the company for over 25 years. In this interview, she provides insights into the evolution of Quotient Sciences’ Nottingham facility and discusses how the organization has transformed from a small 10-bed clinic to a comprehensive drug development campus with six GMP suites. She also shares her perspective on the company’s unique approach to integrating drug development services. HIGHLIGHTS// evolution of Quotient Sciences’ Nottingham facility/ unique approach to integrating drug development services How has the Nottingham site transformed from when it was founded, to what it is today? Initially, we were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90 percent of our work focused on gamma scintigraphic imaging (a diagnostic test that creates images of the body’s internal organs and tissues using gamma rays). Due to the short half-life radionuclides we used to label dosage forms, every product we manufactured had a limited time to be dosed. At the end of 1999, we moved our headquarters to a purpose-built, two-storey facility—now known as Trent House on our now much larger Nottingham campus. We built three good manufacturing practice (GMP) suites on the top floor and three clinical wards on the bottom floor. These were very early days that marked the start of our Translational Pharmaceutics platform. We continued to expand the range of scintigraphy applications we offered in response to changing customer requirements until, in 2008, when we approached the MHRA (UK’s Medicines and Healthcare products Regulatory Agency) with a new request. We asked if it might be possible to work at the same pace as we did in our scintigraphic imaging studies, but do so for conventional drug development, without the radiolabel. We explored the application of ICH Q8 Quality by Design (QbD) guidelines to introduce a compositional design space into the CMC section of our regulatory dossier. This officially created a methodology for applying the Translational Pharmaceutics platform, and we haven't looked back since. Today, we have expanded substantially. Our Nottingham site is a campus of five buildings. We have development and analytical labs, six GMP suites, six clinical wards with a total of 85 beds (where we conduct healthy volunteer phase 1 clinical studies), and many talented colleagues covering our spectrum of CRO and CDMO services. HIGHLIGHTS// officially created a methodology for applying the Translational Pharmaceutics platform/ development and analytical labs/ six GMP suites   How is Translational Pharmaceutics applied to drug development programs? We apply Translational Pharmaceutics across three core applications: first-in-human clinical studies, drug product optimization programs through rapid formulation development and clinical testing, and as a part of human ADME (absorption, distribution, metabolism, and excretion) programs. No matter how a client chooses to work with us to apply Translational Pharmaceutics, the benefits of using a single organization and project management team to integrate services lets our clients remain in control and one step ahead of the emerging data that impacts the success of their molecule. Over all these years, our flagship Translational Pharmaceutics platform for drug development has remained unchanged in the way it empowers our customers and offers them unparalleled flexibility. HIGHLIGHTS// three core applications/ benefits of using a single organization/ clients remain in control   What would you say are the key strengths of Quotient Sciences’ Nottingham site? How do you support customer programs? Nowhere else would a single project manager oversee such a broad spectrum of activities, let alone be expected to ensure seamless, timely progression across functions that in any other company (i.e. at other CDMOs or CROs) would be delivered through multiple operating areas or through the use of a combination of third-party vendors. The project managers do face challenges. But by working with the project team, they are able to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers. A project Gantt chart is our project management team’s guiding light. I believe our project management team is truly world-leading – they communicate well, show great compassion, and lead with integrity. I’m super proud of our high-performing, supportive, cross-functional teams that support our customers when they trust their molecules to us, and work collaboratively to deliver the best possible service. After 25 years at Quotient, I continue to really enjoy going to work. I am indebted to various colleagues for helping me continue to feel this way. HIGHLIGHTS// project management team is truly world-leading/ high-performing, supportive, cross-functional teams/ 25 years at Quotient  

    Impressions: 4916

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    https://www.pharmacompass.com/speak-pharma/translational-pharmaceutics-our-flagship-platform-for-drug-development-empowers-our-clients-with-unparalleled-flexibility

    Radio Compass
    16 Dec 2024
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    VLOG #PharmaReel

    [Sponsored by another company]

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    BMS, J&J, Bayer lead 25,000+ pharma layoffs in 2024; Amylyx, FibroGen, Kronos Bio hit by trial failures, cash crunch

    BMS, J&J, Bayer lead 25,000+ pharma layoffs in 2024; Amylyx, FibroGen, Kronos Bio hit by trial failures, cash crunch

    Since 2022, there has been a significant surge in layoffs by pharmaceutical and biotech companies. While this trend continued into 2024, the industry showed signs of stabilization in the last four months of the year with the pace of layoffs slowing down. Nonetheless, 2024 was a challenging year. Data compiled by PharmaCompass indicates that over 25,000 layoffs were announced in 2024, driven by economic pressures, failed clinical trials, and strategic pivots. Bristol Myers Squibb and Johnson & Johnson led the layoffs with about 2,300 job cuts each. Bayer announced elimination of 1,800 positions.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available) US, Europe, China bear brunt of job cuts; Big Pharma hands pink slips to 10,000 Over 190 biopharma companies announced layoffs in 2024. The year began on a grim note — 27 firms announced significant job cuts in January 2024. By the yearend, Big Pharma alone had contributed more than 10,000 layoffs to the year’s total of over 25,000. Novartis announced over 1,200 job cuts in 2024. It eliminated 330 jobs after it acquired German biotech MorphoSys through the closure of sites in Munich and Boston. Similarly, Bayer announced significant reductions at its US and Swiss facilities.  North America saw increased retrenchments, especially at biotech hubs such as Boston, San Diego, and New Jersey. Massachusetts, with Boston and Cambridge as the epicenter of US biotechnology, saw around 4,000 layoffs, with companies like Relay Therapeutics, Editas Medicine, and Takeda driving the numbers. In San Diego, workforce reductions by Takeda, and Bavarian Nordic collectively resulted in over 900 job losses, significantly impacting the local biotech ecosystem. New Jersey was subject to broader restructuring efforts with BMS and Bayer contributing nearly 1,500 layoffs. The impact in Europe was equally severe. Germany, home to some of the world’s largest pharmaceutical companies, saw over 2,500 layoffs as Bayer and Boehringer Ingelheim scaled back operations. Novartis’ decision to shut down its Munich site added hundreds more to the tally. In Switzerland, Idorsia eliminated 270 positions. Dutch biotech UniQure reduced its workforce by 65 percent (around 300 jobs). That included the sale of a Massachusetts manufacturing facility to Genezen. Denmark also felt the strain, with Leo Pharma cutting 250 roles as part of a strategic revamp. China emerged as another focal point of workforce reductions in 2024. Global pharmaceutical giants, such as Merck and Johnson & Johnson, restructured their operations in response to market complexities in the region. Local companies such as Connect Biopharma, which is transitioning to a US-focused company, also scaled back their presence in the country.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Amylyx, FibroGen, Lyra, Athira drastically reduce staff over setbacks in clinical trials Clinical trial failures were one of the most significant drivers of layoffs in 2024. For instance, Amylyx Pharmaceuticals faced a devastating blow when its amyotrophic lateral sclerosis (ALS) therapy, Relyvrio, failed a confirmatory trial. This led to a 70 percent reduction in its workforce, leaving only 100 employees from the 384 full-time staff reported at the end of 2023. The company’s decision to pull the therapy from the market compounded the layoffs. BioMarin Pharmaceutical had to reduce its workforce, as it streamlined its pipeline in response to trial challenges. In August, the company announced a reduction of 225 employees, citing “organizational redesign efforts”. These layoffs followed 170 redundancies announced earlier in May. FibroGen, once considered a leader in oncology drug development, was among the most heavily impacted. The high-profile failure of its anti-CTGF antibody in two late-stage cancer trials led to the discontinuation of its lead candidate, resulting in a 75 percent reduction in its US workforce. Lyra Therapeutics also implemented a 75 percent workforce reduction, affecting 87 employees, after its chronic rhinosinusitis program struggled. Similarly, Athira Pharma cut 70 percent of its team after its Alzheimer’s candidate failed a phase 2/3 trial.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Cash crunch, mergers compel Kronos Bio, Editas, Vincerx, Gilead to downsize In addition to clinical failures, funding constraints played a pivotal role in reshaping the biotech landscape. Kronos Bio stood out as one of the hardest-hit firms, cutting 21 percent and 83 percent of its existing workforce in March and November, respectively, as it sought to divest assets and conserve cash. Editas Medicine’s inability to secure partnerships for its sickle cell program forced the company to revert to preclinical research, resulting in a 65 percent workforce reduction. The trend of scaling back R&D pipelines was particularly evident among biotechs struggling to advance preclinical programs to clinical trials. Boundless Bio and Senti Bio exemplified this, choosing to focus on a handful of promising candidates, while reducing discovery efforts. Consolidation often results in overlapping roles, leading to inevitable workforce reductions. Apart from the MorphoSys layoffs by Novartis, Vincerx Pharma faced job losses after it got acquired by Oqory (a clinical-stage ADC company). Vincerx had to cut its workforce by 55 percent.  Amid ongoing reorganization efforts, Gilead closed its Seattle, Washington (US), office and laid off 72 employees of its subsidiary Kite Pharma. Gilead also announced that its Kite facility in Philadelphia, Pennsylvania (US), would close by mid-2025. That was followed by 104 additional layoffs at its California headquarters. In April, it had cut 58 jobs in California. Gilead also announced that its Kite facility in Philadelphia would close by mid-2025. Vir Biotechnology reduced its workforce by 25 percent (i.e. 140 layoffs) to focus on its hepatitis program, and GlycoMimetics let go of 80 percent of its workforce after the FDA demanded an additional clinical trial for its leukemia treatment. Meanwhile, Lexicon Pharmaceuticals reduced its workforce by 60 percent after it stopped commercial operations and transitioned back to being a clinical stage company.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Our view It takes decades to build innovation ecosystems. The concentration of layoffs in major biotech hubs has raised concerns about the potential long-term impact on these ecosystems. In 2025, the key challenge will be to maintain the momentum of innovation, as organizations operate with a leaner workforce and a more focused pipeline.  
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    Impressions: 4560

    https://www.pharmacompass.com/radio-compass-blog/bms-j-j-bayer-lead-25-000-pharma-layoffs-in-2024-amylyx-fibrogen-kronos-bio-hit-by-trial-failures-cash-crunch

    #PharmaFlow by PHARMACOMPASS
    16 Jan 2025
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    NEWS #PharmaBuzz

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    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
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    Hetero Labs`s Generics Mycophenolate Mofetil Receives Approval in US
    Hetero Labs`s Generics Mycophenolate Mofetil Receives Approval in US

    22 Oct 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208119

    FDA
    22 Oct 2024
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    Hetero Lab`s Generics Milnacipran HCl Receives Approval in US
    Hetero Lab`s Generics Milnacipran HCl Receives Approval in US

    03 Oct 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205147

    FDA
    03 Oct 2024
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    Hetero's Generic Pemetrexed Disodium Receives Approval in the U.S.
    Hetero's Generic Pemetrexed Disodium Receives Approval in the U.S.

    14 Jun 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215460

    FDA
    14 Jun 2024
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    Hetero Labs Generic Ertugliflozin Receives Tentative Approval in US
    Hetero Labs Generic Ertugliflozin Receives Tentative Approval in US

    17 Apr 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217071

    FDA
    17 Apr 2024
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    Hetero's Generic Eszopiclone Receives Approval in the U.S.
    Hetero's Generic Eszopiclone Receives Approval in the U.S.

    04 Jan 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205504

    FDA
    04 Jan 2024
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    ALL APIs

    read-moreClick the button for full data set
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    01

    Atomoxetin Hydrochloride

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

    Duphat
    Not Confirmed
    arrow

    Atomoxetin Hydrochloride

    India

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

    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20246

    Submission : 2007-02-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-128 - Rev 01

    Issue Date : 2022-08-29

    Type : Chemical

    Substance Number : 2640

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10156

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2017-08-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0021

    Start Marketing Date : 2002-11-26

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Youngjin Pharmaceutical Co., Ltd.

    Registration Date : 2024-05-01

    Registration Number : No. 3838-3-ND(7)

    Manufacturer Name : Hetero Labs Limited

    Manufacturer Address : Sy.No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana, INDIA

     VMF Others AUDIT
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    Market
    Place

    02

    Bicalutamide

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

    Duphat
    Not Confirmed
    arrow

    Bicalutamide

    India

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

    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18496

    Submission : 2005-07-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2012-254 - Rev 02

    Issue Date : 2023-01-09

    Type : Chemical

    Substance Number : 2196

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 226MF10046

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2014-02-20

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0001

    Start Marketing Date : 1995-10-04

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

    Product
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    Market
    Place

    03

    Escitalopram Oxalate

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

    Duphat
    Not Confirmed
    arrow

    Escitalopram Oxalate

    India

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

    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-03-17

    Pay. Date : 2013-03-07

    DMF Number : 17960

    Submission : 2004-12-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-306 - Rev 00

    Issue Date : 2023-05-23

    Type : Chemical

    Substance Number : 2733

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 303MF10125

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2021-08-16

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0007

    Start Marketing Date : 2002-08-14

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Mirae Pharmchem Co., Ltd.

    Registration Date : 2021-04-21

    Registration Number : 20180604-209-J-223(8)

    Manufacturer Name : Hetero Labs Limited

    Manufacturer Address : Survey. No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana State India

     VMF Others AUDIT
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    Market
    Place

    04

    Finasteride

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

    Duphat
    Not Confirmed
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    Finasteride

    India

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

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    Duphat
    Not Confirmed
    • fda
    • EDQM
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-05-16

    Pay. Date : 2014-05-05

    DMF Number : 20893

    Submission : 2007-09-27

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2011-351 - Rev 03

    Issue Date : 2024-11-04

    Type : Chemical

    Substance Number : 1615

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 227MF10060

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2015-03-06

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0022

    Start Marketing Date : 1992-06-19

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Sungwoo Chemical Co., Ltd.

    Registration Date : 2014-09-19

    Registration Number : 20130314-94-E-111-08(1)

    Manufacturer Name : Hetero Labs Limited

    Manufacturer Address : Sy.No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana, INDIA

     VMF Others AUDIT
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    Market
    Place

    05

    Irbesartan

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

    Duphat
    Not Confirmed
    arrow

    Irbesartan

    India

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

    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-05-27

    Pay. Date : 2016-05-12

    DMF Number : 17507

    Submission : 2004-07-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-104 - Rev 04

    Issue Date : 2024-03-25

    Type : Chemical

    Substance Number : 2465

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10007

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2016-01-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0005

    Start Marketing Date : 1997-09-30

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    06

    Lamivudine

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

    Duphat
    Not Confirmed
    arrow

    Lamivudine

    India

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

    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-12-27

    Pay. Date : 2012-12-03

    DMF Number : 18252

    Submission : 2005-04-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2019-082 - Rev 01

    Issue Date : 2023-03-20

    Type : Chemical

    Substance Number : 2217

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10157

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2017-08-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0016

    Start Marketing Date : 1995-11-17

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    07

    Levetiracetam

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

    Duphat
    Not Confirmed
    arrow

    Levetiracetam

    India

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

    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-12-26

    Pay. Date : 2012-11-30

    DMF Number : 17738

    Submission : 2004-10-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2014-113 - Rev 02

    Issue Date : 2024-11-25

    Type : Chemical

    Substance Number : 2535

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 302MF10091

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2020-07-29

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0006

    Start Marketing Date : 1999-11-30

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Myungin Pharmaceutical Co., Ltd.

    Registration Date : 2017-08-03

    Registration Number : 20120210-183-I-21-19(6)

    Manufacturer Name : Hetero Labs Limited

    Manufacturer Address : Sy No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana State, India

     VMF Others AUDIT
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    Market
    Place

    08

    Lisinopril

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

    Duphat
    Not Confirmed
    arrow

    Lisinopril

    India

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

    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-11

    Pay. Date : 2012-11-29

    DMF Number : 16510

    Submission : 2003-03-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2016-197 - Rev 02

    Issue Date : 2024-07-03

    Type : Chemical

    Substance Number : 1120

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10145

    Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telangana, INDIA

    Initial Date of Registration : 2010-04-22

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-04

    Valid Till : 2025-07-03

    Written Confirmation Number : WC-0040

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65977-0009

    Start Marketing Date : 1987-12-29

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

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    Market
    Place

    09

    Losartan Potassium

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

    Duphat
    Not Confirmed
    arrow

    Losartan Potassium

    India

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

    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-04-30

    Pay. Date : 2013-04-23

    DMF Number : 19988

    Submission : 2006-11-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2009-247 - Rev 09

    Issue Date : 2024-12-02

    Type : Chemical

    Substance Number : 2232

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 303MF10096

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2021-06-22

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0008

    Start Marketing Date : 1995-04-14

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

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    Market
    Place

    10

    Olanzapine

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

    Duphat
    Not Confirmed
    arrow

    Olanzapine

    India

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

    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-01-24

    Pay. Date : 2013-12-10

    DMF Number : 20591

    Submission : 2007-06-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2022-126 - Rev 00

    Issue Date : 2022-06-22

    Type : Chemical

    Substance Number : 2258

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 227MF10065

    Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telangana, INDIA

    Initial Date of Registration : 2015-03-06

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-04

    Valid Till : 2025-07-03

    Written Confirmation Number : WC-0040

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65977-0026

    Start Marketing Date : 1996-09-30

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Lee Sung International Co., Ltd.

    Registration Date : 2021-05-18

    Registration Number : 20210518-209-J-928

    Manufacturer Name : Hetero Drugs Limited Unit I

    Manufacturer Address : Survey. No. 213, 214 and 255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Telangana State, India

     VMF Others AUDIT
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    USDMF

    read-more
    read-more

    01

    Abacavir Sulfate

    India
    Duphat
    Not Confirmed
    arrow

    02

    Abacavir Sulfate (process-ii), Usp

    India
    Duphat
    Not Confirmed
    arrow

    03

    Abiraterone Acetate

    India
    Duphat
    Not Confirmed
    arrow

    04

    Acyclovir

    India
    Duphat
    Not Confirmed
    arrow

    05

    Afatinib Dimaleate

    India
    Duphat
    Not Confirmed
    arrow

    06

    Afatinib Dimaleate (form A)

    India
    Duphat
    Not Confirmed
    arrow

    07

    Alectinib Hydrochloride

    India
    Duphat
    Not Confirmed
    arrow

    08

    Alfuzosin Hydrochloride

    India
    Duphat
    Not Confirmed
    arrow

    09

    Allopurinol

    India
    Duphat
    Not Confirmed
    arrow

    10

    Amifampridine Phosphate

    India
    Duphat
    Not Confirmed
    arrow
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    CEP/COS

    read-more
    read-more

    01

    Abacavir sulfate

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    02

    Aciclovir

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    03

    Allopurinol

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    04

    Amlodipine besilate

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    05

    Amlodipine besilate, Process II

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    06

    Anastrozole

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    07

    Aprepitant

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    08

    Aripiprazole, Type-I

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    09

    Atazanavir sulfate

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    10

    Atomoxetine hydrochloride

    CEP/COS

    Duphat
    Not Confirmed
    arrow
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    JDMF

    read-more
    read-more

    01

    Abiraterone Acetate

    JDMF

    Duphat
    Not Confirmed
    arrow

    Abiraterone Acetate

    India
    arrow
    Duphat
    Not Confirmed
    • fda
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    Hetero Drugs

    Registration Number : 304MF10108

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana I...

    Initial Date of Registration : 2022-08-03

    Latest Date of Registration : 2022-08-03

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    Market
    Place

    02

    Abiraterone acetate

    JDMF

    Duphat
    Not Confirmed
    arrow

    Abiraterone acetate

    India
    arrow
    Duphat
    Not Confirmed
    • fda
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    Hetero Drugs

    Registration Number : 301MF10049

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana I...

    Initial Date of Registration : 2019-08-20

    Latest Date of Registration : 2019-08-20

    blank

    Product
    Web Link

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    #PipelineProspector

    Market
    Place

    03

    Amlodipine besylate

    JDMF

    Duphat
    Not Confirmed
    arrow

    Amlodipine besylate

    India
    arrow
    Duphat
    Not Confirmed
    • fda
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    Hetero Drugs

    Registration Number : 218MF10912

    Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Andhra...

    Initial Date of Registration : 2006-11-10

    Latest Date of Registration : 2006-11-10

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    Market
    Place

    04

    Amlodipine besylate "F"

    JDMF

    Duphat
    Not Confirmed
    arrow

    Amlodipine besylate "F"

    India
    arrow
    Duphat
    Not Confirmed
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    Hetero Drugs

    Registration Number : 223MF10106

    Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telang...

    Initial Date of Registration : 2011-07-15

    Latest Date of Registration : 2011-07-15

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    Market
    Place

    05

    Anastrozole

    JDMF

    Duphat
    Not Confirmed
    arrow

    Anastrozole

    India
    arrow
    Duphat
    Not Confirmed
    • fda
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    • WHO-GMP
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    Hetero Drugs

    Registration Number : 228MF10140

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana I...

    Initial Date of Registration : 2016-08-02

    Latest Date of Registration : 2016-08-02

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    Market
    Place

    06

    Apremi last

    JDMF

    Duphat
    Not Confirmed
    arrow

    Apremi last

    India
    arrow
    Duphat
    Not Confirmed
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    Hetero Drugs

    Registration Number : 306MF10024

    Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telang...

    Initial Date of Registration : 2024-02-07

    Latest Date of Registration : 2024-02-07

    blank

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    Market
    Place

    07

    Aripiprazole

    JDMF

    Duphat
    Not Confirmed
    arrow

    Aripiprazole

    India
    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Hetero Drugs

    Registration Number : 306MF10017

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana I...

    Initial Date of Registration : 2024-01-24

    Latest Date of Registration : 2024-01-24

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    Market
    Place

    08

    Aripiprazole

    JDMF

    Duphat
    Not Confirmed
    arrow

    Aripiprazole

    India
    arrow
    Duphat
    Not Confirmed
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    Hetero Drugs

    Registration Number : 228MF10005

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana I...

    Initial Date of Registration : 2016-01-08

    Latest Date of Registration : 2016-01-08

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    Market
    Place

    09

    Atomoxetine hydrochloride

    JDMF

    Duphat
    Not Confirmed
    arrow

    Atomoxetine hydrochloride

    India
    arrow
    Duphat
    Not Confirmed
    • fda
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    Hetero Drugs

    Registration Number : 229MF10156

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana I...

    Initial Date of Registration : 2017-08-08

    Latest Date of Registration : 2017-08-08

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    Market
    Place

    10

    Atorvastatin calcium hydrate [Form-I]

    JDMF

    Duphat
    Not Confirmed
    arrow

    Atorvastatin calcium hydrate [Form-I]

    India
    arrow
    Duphat
    Not Confirmed
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    Hetero Drugs

    Registration Number : 229MF10202

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana I...

    Initial Date of Registration : 2017-11-20

    Latest Date of Registration : 2017-11-20

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    EU WC

    read-more
    read-more

    01

    Abacavir IH

    India
    Duphat
    Not Confirmed
    arrow

    02

    Abacavir Sulfate (USP)

    India
    Duphat
    Not Confirmed
    arrow

    03

    Abacavir Sulphate USP

    India
    Duphat
    Not Confirmed
    arrow

    04

    Abacavir Sulfate (USP)

    India
    Duphat
    Not Confirmed
    arrow

    05

    Abiraterone Acetate IH/USP

    India
    Duphat
    Not Confirmed
    arrow

    06

    Acyclovir (USP)

    India
    Duphat
    Not Confirmed
    arrow

    07

    Adefovir Dipivoxil (IH)

    India
    Duphat
    Not Confirmed
    arrow

    08

    Afatinib Dimaleate IH

    India
    Duphat
    Not Confirmed
    arrow

    09

    Afatinib Dimaleate IH

    India
    Duphat
    Not Confirmed
    arrow

    10

    Alfuzosin Hydrochloride (USP...

    India
    Duphat
    Not Confirmed
    arrow
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    KDMF

    read-more
    read-more

    01

    Abiraterone acetate

    India
    Duphat
    Not Confirmed
    arrow

    Abiraterone acetate

    India
    arrow
    Duphat
    Not Confirmed
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    Hetero Drugs

    Registrant Name : Lee Sung International Co., Ltd.

    Registration Date : 2022-12-05

    Registration Number : Thu21-22-ND

    Manufacturer Name : Hetero Labs Limited Unit-I

    Manufacturer Address : Survey No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, SangaReddy District.-50231...

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    Market
    Place

    02

    Abiraterone acetate

    India
    Duphat
    Not Confirmed
    arrow

    Abiraterone acetate

    India
    arrow
    Duphat
    Not Confirmed
    • fda
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    Hetero Drugs

    Registrant Name : Hanmi Pharmaceutical Co., Ltd.

    Registration Date : 2023-03-03

    Registration Number : Thu21-22-ND(1)

    Manufacturer Name : Hetero Labs Limited Unit-I

    Manufacturer Address : Survey No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, SangaReddy District.-50231...

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    Market
    Place

    03

    Amlodipine besilate

    India
    Duphat
    Not Confirmed
    arrow

    Amlodipine besilate

    India
    arrow
    Duphat
    Not Confirmed
    • fda
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    • WHO-GMP
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    Hetero Drugs

    Registrant Name : Hanmi Pharmaceutical Co., Ltd.

    Registration Date : 2016-02-25

    Registration Number : 20120120-130-H-183-36(3)

    Manufacturer Name : Hetero Drugs Limited

    Manufacturer Address : Sy.No.213,214&255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Tela...

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    04

    Amlodipine besilate

    India
    Duphat
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    Amlodipine besilate

    India
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    Hetero Drugs

    Registrant Name : Wonpung Pharmaceutical Co., Ltd.

    Registration Date : 2012-01-20

    Registration Number : 20120120-130-H-183-36

    Manufacturer Name : Hetero Drugs Limited

    Manufacturer Address : Sy.No.213,214&255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Tela...

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    05

    Amlodipine besilate

    India
    Duphat
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    Amlodipine besilate

    India
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    Hetero Drugs

    Registrant Name : Celltrion Pharmaceutical Co., Ltd.

    Registration Date : 2015-04-15

    Registration Number : 20120120-130-H-183-36(2)

    Manufacturer Name : Hetero Drugs Limited.

    Manufacturer Address : Sy.No.213,214&255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Tela...

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    06

    Amlodipine besilate

    India
    Duphat
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    Amlodipine besilate

    India
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    Duphat
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    Hetero Drugs

    Registrant Name : Novartis Korea Ltd.

    Registration Date : 2022-10-18

    Registration Number : 20120120-130-H-183-36(7)

    Manufacturer Name : Hetero Drugs Limited

    Manufacturer Address : Sy.No.213,214&255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Tela...

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    07

    Amlodipine besilate

    India
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    Amlodipine besilate

    India
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    Hetero Drugs

    Registrant Name : Seongi Bio Co., Ltd.

    Registration Date : 2014-03-06

    Registration Number : 20120120-130-H-183-36(1)

    Manufacturer Name : Hetero Drugs Limited

    Manufacturer Address : Sy.No.213,214&255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Tela...

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    08

    Amlodipine besilate

    India
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    Amlodipine besilate

    India
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    Hetero Drugs

    Registrant Name : Hoosung Bio Co., Ltd.

    Registration Date : 2023-09-08

    Registration Number : 20120120-130-H-183-36(8)

    Manufacturer Name : Hetero Drugs Limited

    Manufacturer Address : Sy.No.213,214&255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Tela...

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    09

    Amlodipine besilate

    India
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    Amlodipine besilate

    India
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    Duphat
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    Hetero Drugs

    Registrant Name : Inist Farm Co., Ltd.

    Registration Date : 2017-04-17

    Registration Number : 20120120-130-H-183-36(5)

    Manufacturer Name : Hetero Drugs Limited

    Manufacturer Address : Sy.No.213.214&255, Bonthapally Village, Jinnaram Mandal, Medak District, Telangana, I...

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    10

    Amlodipine besilate

    India
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    Amlodipine besilate

    India
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    Hetero Drugs

    Registrant Name : Lee Sung International Co., Ltd.

    Registration Date : 2019-10-17

    Registration Number : 20120120-130-H-183-36(6)

    Manufacturer Name : Hetero Drugs Limited

    Manufacturer Address : Sy.No.213,214&255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Tela...

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    NDC API

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    01

    ABACAVIR SULFATE

    India
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    ABACAVIR SULFATE

    India
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    Hetero Drugs

    NDC Package Code : 68554-0063

    Start Marketing Date : 1998-12-17

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    02

    ABACAVIR SULFATE

    India
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    ABACAVIR SULFATE

    India
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    Hetero Drugs

    NDC Package Code : 68554-0032

    Start Marketing Date : 1998-12-17

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    03

    ABIRATERONE ACETATE

    India
    Duphat
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    ABIRATERONE ACETATE

    India
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    Hetero Drugs

    NDC Package Code : 68554-0082

    Start Marketing Date : 2011-04-28

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    04

    ACYCLOVIR

    India
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    Not Confirmed
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    ACYCLOVIR

    India
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    Hetero Drugs

    NDC Package Code : 65977-0058

    Start Marketing Date : 1982-03-29

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    05

    ACYCLOVIR

    India
    Duphat
    Not Confirmed
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    ACYCLOVIR

    India
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    Hetero Drugs

    NDC Package Code : 68554-0159

    Start Marketing Date : 1982-03-29

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    06

    AFATINIB DIMALEATE

    India
    Duphat
    Not Confirmed
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    AFATINIB DIMALEATE

    India
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    Hetero Drugs

    NDC Package Code : 68554-0107

    Start Marketing Date : 2013-07-12

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    07

    ALECTINIB HYDROCHLORIDE

    India
    Duphat
    Not Confirmed
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    ALECTINIB HYDROCHLORIDE

    India
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    Hetero Drugs

    NDC Package Code : 68554-0150

    Start Marketing Date : 2015-12-11

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    08

    ALFUZOSIN HYDROCHLORIDE

    India
    Duphat
    Not Confirmed
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    ALFUZOSIN HYDROCHLORIDE

    India
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    Hetero Drugs

    NDC Package Code : 65977-0023

    Start Marketing Date : 2003-12-06

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    09

    ALLOPURINOL

    India
    Duphat
    Not Confirmed
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    ALLOPURINOL

    India
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    Hetero Drugs

    NDC Package Code : 65977-0124

    Start Marketing Date : 1982-01-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    10

    AMIFAMPRIDINE PHOSPHATE

    India
    Duphat
    Not Confirmed
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    AMIFAMPRIDINE PHOSPHATE

    India
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    Hetero Drugs

    NDC Package Code : 65977-0138

    Start Marketing Date : 2018-11-28

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    LISTED APIs

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    Abacavir

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    Market
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    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offe...
    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    01

    Abacavir

    India
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    Not Confirmed
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    Abacavir

    India
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    Hetero Drugs

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.

    About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosage...

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    Abiraterone

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    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offe...
    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    02

    Abiraterone

    India
    Duphat
    Not Confirmed
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    Abiraterone

    India
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    Hetero Drugs

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.

    About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosage...

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    Acalabrutinib

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    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offe...
    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    03

    Acalabrutinib

    India
    Duphat
    Not Confirmed
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    Acalabrutinib

    India
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    Hetero Drugs

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.

    About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosage...

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    Aciclovir

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    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offe...
    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    Aciclovir

    India
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    Aciclovir

    India
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    Hetero Drugs

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.

    About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosage...

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    Adefovir Dipivoxil

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    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offe...
    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    Adefovir Dipivoxil

    India
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    Not Confirmed
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    Adefovir Dipivoxil

    India
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    Hetero Drugs

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.

    About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosage...

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    Afatinib

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    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offe...
    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    06

    Afatinib

    India
    Duphat
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    Afatinib

    India
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    Hetero Drugs

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.

    About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosage...

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    Alectinib Hydrochloride

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    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offe...
    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    Alectinib Hydrochloride

    India
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    Alectinib Hydrochloride

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    Hetero Drugs

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.

    About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosage...

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    Alfuzosin HCl

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    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offe...
    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    Alfuzosin HCl

    India
    Duphat
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    Alfuzosin HCl

    India
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    Hetero Drugs

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.

    About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosage...

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    Alogliptin Benzoate

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    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offe...
    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    Alogliptin Benzoate

    India
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    Alogliptin Benzoate

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    Hetero Drugs

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.

    About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosage...

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    Alpelisib

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    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offe...
    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    Alpelisib

    India
    Duphat
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    Alpelisib

    India
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    Hetero Drugs

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.

    About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosage...

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    Drugs in Development

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    Hetero Gets CDSCO Panel Nod to Study Tedizolid Phosphate for Bacterial Skin Infections

    Details:

    Tedizolid phosphate is an oxazolidinone-class antibacterial drug indicated in adult patients for the treatment of acute bacterial skin and skin structure infections.


    Lead Product(s): Tedizolid

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Tedizolid Phosphate-Generic

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 16, 2024

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    Hetero Drugs

    India
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    Hetero Drugs

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    Lead Product(s) : Tedizolid

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Hetero Gets CDSCO Panel Nod to Study Tedizolid Phosphate for Bacterial Skin Infections

    Details : Tedizolid phosphate is an oxazolidinone-class antibacterial drug indicated in adult patients for the treatment of acute bacterial skin and skin structure infections.

    Brand Name : Tedizolid Phosphate-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    August 16, 2024

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    Pfizer's "Game-Changing" COVID-19 pill, Paxlovid, Gets India’s DCGI Nod

    Details:

    India's drug regulator approved antiviral medication Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for restricted emergency use against Covid-19 amid rising infections in the country.


    Lead Product(s): Ritonavir,Nirmatrelvir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Paxlovid

    Study Phase: ApprovedProduct Type: Small molecule

    Recipient: Pfizer Inc

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 23, 2022

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    02

    Hetero Drugs

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    Hetero Drugs

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    Lead Product(s) : Ritonavir,Nirmatrelvir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Recipient : Pfizer Inc

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Pfizer's "Game-Changing" COVID-19 pill, Paxlovid, Gets India’s DCGI Nod

    Details : India's drug regulator approved antiviral medication Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for restricted emergency use against Covid-19 amid rising infections in the country.

    Brand Name : Paxlovid

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    April 23, 2022

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    Hetero Enters Into a Voluntary Licensing Agreement with MSD for the Manufacturing and Distribution of ‘Molnupiravir

    Details:

    Under this licensing deal, Hetero will be allowed to expand access of Molnupiravir in India and in other low-and middle-income countries (LMICs), following the approvals for emergency use authorization by local regulatory agencies.


    Lead Product(s): Molnupiravir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: MK-4482

    Study Phase: Phase IIIProduct Type: Small molecule

    Recipient: Merck & Co

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement April 27, 2021

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    03

    Hetero Drugs

    India
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    Hetero Drugs

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    Lead Product(s) : Molnupiravir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase III

    Recipient : Merck & Co

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Hetero Enters Into a Voluntary Licensing Agreement with MSD for the Manufacturing and Distribution...

    Details : Under this licensing deal, Hetero will be allowed to expand access of Molnupiravir in India and in other low-and middle-income countries (LMICs), following the approvals for emergency use authorization by local regulatory agencies.

    Brand Name : MK-4482

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    April 27, 2021

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    Hetero Announces the Approval and Launch of First Generic ‘COVIFOR’ (Remdesivir) in India for the Treatment of Covid-19

    Details:

    Hetero announced today that it has received the manufacturing and marketing approval for the investigational antiviral medicine ‘Remdesivir’ from the Drug Controller General of India (DCGI) for the treatment of Covid-19.


    Lead Product(s): Remdesivir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Covifor

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable June 21, 2020

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    Hetero Drugs

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    Hetero Drugs

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    Lead Product(s) : Remdesivir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Hetero Announces the Approval and Launch of First Generic ‘COVIFOR’ (Remdesivir) in India for ...

    Details : Hetero announced today that it has received the manufacturing and marketing approval for the investigational antiviral medicine ‘Remdesivir’ from the Drug Controller General of India (DCGI) for the treatment of Covid-19.

    Brand Name : Covifor

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    June 21, 2020

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    FDF Dossiers

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    01

    Brand Name : Hetbaclam

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Brand Name : Hetbaclam

    India
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir

    Hetero Drugs

    Dosage Form : FCT

    Brand Name : Hetbaclam

    Dosage Strength : 600mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    02

    Brand Name : Heteruam 600/300 mg

    India
    Pharma, Lab & Chemical Expo
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    Brand Name : Heteruam 600/300 mg

    India
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir

    Hetero Drugs

    Dosage Form : FCT

    Brand Name : Heteruam 600/300 mg

    Dosage Strength : 600mg

    Packaging : 28X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    03

    Brand Name : Heteruam 600/300 mg

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Brand Name : Heteruam 600/300 mg

    India
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    Pharma, Lab & Chemical Expo
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir

    Hetero Drugs

    Dosage Form : FCT

    Brand Name : Heteruam 600/300 mg

    Dosage Strength : 600mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    04

    Brand Name : ABACAVIR SULFATE

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE

    India
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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Regulatory Info : RX

    Registration Country : USA

    ABACAVIR SULFATE

    Hetero Drugs

    Dosage Form : SOLUTION;ORAL

    Brand Name : ABACAVIR SULFATE

    Dosage Strength : EQ 20MG BASE/ML

    Packaging :

    Approval Date : 2016-09-26

    Application Number : 201107

    Regulatory Info : RX

    Registration Country : USA

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    05

    Brand Name : ABACAVIR SULFATE

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE

    India
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    Pharma, Lab & Chemical Expo
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    Regulatory Info : RX

    Registration Country : USA

    ABACAVIR SULFATE

    Hetero Drugs

    Dosage Form : TABLET;ORAL

    Brand Name : ABACAVIR SULFATE

    Dosage Strength : EQ 300MG BASE

    Packaging :

    Approval Date : 2013-09-13

    Application Number : 91560

    Regulatory Info : RX

    Registration Country : USA

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    06

    Brand Name : ABACAVIR SULFATE; LA...

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE; LA...

    India
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    Regulatory Info :

    Registration Country : USA

    ABACAVIR SULFATE; LAMIVUDINE

    Hetero Drugs

    Dosage Form : TABLET;ORAL

    Brand Name : ABACAVIR SULFATE; LAMIVUD...

    Dosage Strength : 600;300MG

    Packaging :

    Approval Date :

    Application Number : 205412

    Regulatory Info :

    Registration Country : USA

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    07

    Brand Name : Hetacav 300

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Brand Name : Hetacav 300

    India
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir Sulphate

    Hetero Drugs

    Dosage Form : FCT

    Brand Name : Hetacav 300

    Dosage Strength : 300mg

    Packaging : 60X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Market
    Place

    08

    Brand Name : Hetacav Oral Solutio...

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Brand Name : Hetacav Oral Solutio...

    India
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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir Sulphate

    Hetero Drugs

    Dosage Form : SOL

    Brand Name : Hetacav Oral Solution Het...

    Dosage Strength : 20mg/ml

    Packaging : 240X1mg/ml

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    09

    Brand Name : ABACAVIR; LAMIVUDINE

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Brand Name : ABACAVIR; LAMIVUDINE

    India
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    Not Confirmed
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    Regulatory Info :

    Registration Country : USA

    ABACAVIR; LAMIVUDINE

    Hetero Drugs

    Dosage Form : TABLET;ORAL

    Brand Name : ABACAVIR; LAMIVUDINE

    Dosage Strength : 60MG;30MG

    Packaging :

    Approval Date :

    Application Number : 207369

    Regulatory Info :

    Registration Country : USA

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    10

    Brand Name : Heteran 250

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Brand Name : Heteran 250

    India
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    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
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    • WHO-GMP
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abiraterone Acetate

    Hetero Drugs

    Dosage Form : TAB

    Brand Name : Heteran 250

    Dosage Strength : 250mg

    Packaging : 120X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    FDA Orange Book

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    01

    Brand Name : ABACAVIR SULFATE

    India
    Duphat
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE

    India
    Duphat
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    RLD : No

    TE Code : AB

    ABACAVIR SULFATE

    Hetero Drugs

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE

    Dosage Strength : EQ 300MG BASE

    Approval Date : 2013-09-13

    Application Number : 91560

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    02

    Brand Name : ABACAVIR SULFATE

    India
    Duphat
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE

    India
    Duphat
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    RLD : No

    TE Code : AA

    ABACAVIR SULFATE

    Hetero Drugs

    Dosage Form : SOLUTION; ORAL

    Proprietary Name : ABACAVIR SULFATE

    Dosage Strength : EQ 20MG BASE/ML

    Approval Date : 2016-09-26

    Application Number : 201107

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AA

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    03

    Brand Name : ABACAVIR SULFATE; LA...

    India
    Duphat
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE; LA...

    India
    Duphat
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    RLD :

    TE Code :

    ABACAVIR SULFATE; LAMIVUDINE

    Hetero Drugs

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE; LAMIVU...

    Dosage Strength : 600;300MG

    Approval Date :

    Application Number : 205412

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    Brand Name : ABACAVIR; LAMIVUDINE

    India
    Duphat
    Not Confirmed
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    Brand Name : ABACAVIR; LAMIVUDINE

    India
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    RLD :

    TE Code :

    ABACAVIR; LAMIVUDINE

    Hetero Drugs

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR; LAMIVUDINE

    Dosage Strength : 60MG;30MG

    Approval Date :

    Application Number : 207369

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    05

    Brand Name : ACYCLOVIR

    India
    Duphat
    Not Confirmed
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    Brand Name : ACYCLOVIR

    India
    Duphat
    Not Confirmed
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    RLD : No

    TE Code : AB

    ACYCLOVIR

    Hetero Drugs

    Dosage Form : TABLET; ORAL

    Proprietary Name : ACYCLOVIR

    Dosage Strength : 400MG

    Approval Date : 2013-10-29

    Application Number : 203834

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Brand Name : ACYCLOVIR

    India
    Duphat
    Not Confirmed
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    Brand Name : ACYCLOVIR

    India
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    RLD : No

    TE Code : AB

    ACYCLOVIR

    Hetero Drugs

    Dosage Form : TABLET; ORAL

    Proprietary Name : ACYCLOVIR

    Dosage Strength : 800MG

    Approval Date : 2013-10-29

    Application Number : 203834

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Brand Name : ACYCLOVIR

    India
    Duphat
    Not Confirmed
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    Brand Name : ACYCLOVIR

    India
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    RLD : No

    TE Code : AB

    ACYCLOVIR

    Hetero Drugs

    Dosage Form : SUSPENSION; ORAL

    Proprietary Name : ACYCLOVIR

    Dosage Strength : 200MG/5ML

    Approval Date : 2022-07-01

    Application Number : 215669

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    08

    Brand Name : ALLOPURINOL

    India
    Duphat
    Not Confirmed
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    Brand Name : ALLOPURINOL

    India
    Duphat
    Not Confirmed
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    RLD : No

    TE Code : AB

    ALLOPURINOL

    Hetero Drugs

    Dosage Form : TABLET; ORAL

    Proprietary Name : ALLOPURINOL

    Dosage Strength : 100MG

    Approval Date : 2023-08-03

    Application Number : 217748

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    09

    Brand Name : ALLOPURINOL

    India
    Duphat
    Not Confirmed
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    Brand Name : ALLOPURINOL

    India
    Duphat
    Not Confirmed
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    RLD : No

    TE Code : AB

    ALLOPURINOL

    Hetero Drugs

    Dosage Form : TABLET; ORAL

    Proprietary Name : ALLOPURINOL

    Dosage Strength : 300MG

    Approval Date : 2023-08-03

    Application Number : 217748

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    10

    Brand Name : AMLODIPINE BESYLATE ...

    India
    Duphat
    Not Confirmed
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    Brand Name : AMLODIPINE BESYLATE ...

    India
    Duphat
    Not Confirmed
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    RLD : No

    TE Code : AB

    AMLODIPINE BESYLATE; VALSARTAN

    Hetero Drugs

    Dosage Form : TABLET; ORAL

    Proprietary Name : AMLODIPINE BESYLATE AND ...

    Dosage Strength : EQ 5MG BASE;160MG

    Approval Date : 2016-09-16

    Application Number : 205137

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Inspections and registrations

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    FDA

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    01

    FDA Audited

    USA
    BIO Partnering at JPM
    Not Confirmed
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    FDA Audited

    USA
    arrow
    BIO Partnering at JPM
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2011-12-09

    Hetero Drugs

    City : Medak District

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2011-12-09

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    02

    FDA Audited

    USA
    BIO Partnering at JPM
    Not Confirmed
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    FDA Audited

    USA
    arrow
    BIO Partnering at JPM
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2011-12-15

    Hetero Drugs

    City : Visakhapatnam

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2011-12-15

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    03

    FDA Audited

    USA
    BIO Partnering at JPM
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    BIO Partnering at JPM
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2013-11-29

    Hetero Drugs

    City : Medak District

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2013-11-29

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    04

    FDA Audited

    USA
    BIO Partnering at JPM
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    BIO Partnering at JPM
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-03-14

    Hetero Drugs

    City : Sangareddy District

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-03-14

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    05

    FDA Audited

    USA
    BIO Partnering at JPM
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    BIO Partnering at JPM
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-02-10

    Hetero Drugs

    City : Visakhapatnam

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-02-10

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    06

    FDA Audited

    USA
    BIO Partnering at JPM
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    BIO Partnering at JPM
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-09-15

    Hetero Drugs

    City : Medak District

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-09-15

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    EDQM

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    01

    GMP Certified

    EU
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    GMP Certified

    EU
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed

    Hetero Drugs

    Type : GMP Certificates

    Number : HeteroLabs/...

    EudraGMDP Key : 10988

    Country : India

    Issue Date :

    Post Code : Andhra Pradesh

    NCA Ref : 1.0988131498...

    City : Jadcherla Mandal

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    02

    GMP Certified

    EU
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    GMP Certified

    EU
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed

    Hetero Drugs

    Type : GMP Certificates

    Number : HeteroLabs/...

    EudraGMDP Key : 10988

    Country : India

    Issue Date :

    Post Code : Andhra Pradesh

    NCA Ref : 1.0988131498...

    City : Jadcherla Mandal

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    03

    GMP Certified

    EU
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    GMP Certified

    EU
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed

    Hetero Drugs

    Type : GMP Certificates

    Number : 11/09557-9

    EudraGMDP Key : 11251

    Country : India

    Issue Date :

    Post Code : Pin-509301

    NCA Ref : 1.1251132258...

    City : Andhra Pradesh

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    04

    GMP Certified

    EU
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    GMP Certified

    EU
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed

    Hetero Drugs

    Type : GMP Certificates

    Number : DK API-H 00...

    EudraGMDP Key : 11637

    Country : India

    Issue Date :

    Post Code : 502313

    NCA Ref : 260609

    City : Hyderabad, Andhra Prade...

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    05

    GMP Certified

    EU
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    GMP Certified

    EU
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed

    Hetero Drugs

    Type : GMP Certificates

    Number : 005/2012/RO

    EudraGMDP Key : 11637

    Country : India

    Issue Date :

    Post Code : 502313

    NCA Ref : 260609

    City : Hyderabad, Andhra Prade...

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    06

    GMP Certified

    EU
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed

    Hetero Drugs

    Type : GMP Certificates

    Number : HeteroLabs/...

    EudraGMDP Key : 10988

    Country : India

    Issue Date :

    Post Code : Andhra Pradesh

    NCA Ref : 1.0988131498...

    City : Jadcherla Mandal

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    07

    GMP Certified

    EU
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed

    Hetero Drugs

    Type : GMP Certificates

    Number : F112/01/201...

    EudraGMDP Key : 16279

    Country : India

    Issue Date :

    Post Code : 531081

    NCA Ref : 1.6279136732...

    City : Andhra Pradesh

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    08

    GMP Certified

    EU
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed

    Hetero Drugs

    Type : GMP Certificates

    Number : FI11/01/201...

    EudraGMDP Key : 16408

    Country : India

    Issue Date :

    Post Code : 531081 Andhra Pradesh

    NCA Ref : 1.6408136871...

    City : Visakhapatnam District

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    09

    GMP Certified

    EU
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed

    Hetero Drugs

    Type : GMP Certificates

    Number : FI12/01/201...

    EudraGMDP Key : 16444

    Country : India

    Issue Date :

    Post Code : 531081 Andhra Pradesh

    NCA Ref : 1.6444136871...

    City : Visakhapatnam District

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    10

    GMP Certified

    EU
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed

    Hetero Drugs

    Type : GMP Certificates

    Number : FI06/02/201...

    EudraGMDP Key : 10988

    Country : India

    Issue Date :

    Post Code : Andhra Pradesh

    NCA Ref : 1.0988131498...

    City : Jadcherla Mandal

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    WHO-GMP

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    01

    WHO GMP Certified

    Switzerland
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    WHO GMP Certified

    Switzerland
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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Hetero Drugs

    Name and address of WHO GMP certified Manufacturer : Hetero Labs Limited (Unit - 11) Vill. Kalyanpur, Chakkan Road, Baddi, Distt. Solan (H.P.)

    Country : India

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    02

    WHO GMP Certified

    Switzerland
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    WHO GMP Certified

    Switzerland
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    Not Confirmed
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    Hetero Drugs

    Name and address of WHO GMP certified Manufacturer : Hetero Labs Ltd, Sy.No.10, IDA., Gaddapotharam, Medak Dist.

    Country : India

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    03

    WHO GMP Certified

    Switzerland
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    WHO GMP Certified

    Switzerland
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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Hetero Drugs

    Name and address of WHO GMP certified Manufacturer : Hetero Labs Ltd, Sy.No.10, IDA., Gaddapotharam, Medak Dist.

    Country : India

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    04

    WHO GMP Certified

    Switzerland
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    WHO GMP Certified

    Switzerland
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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Hetero Drugs

    Name and address of WHO GMP certified Manufacturer : Hetero Labs Ltd, Unit-V, Sy.No. 410&411, APIIC Formulation SEZ, Polepally Village, Jedcherla Mandal, Mahaboobnagar

    Country : India

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    05

    WHO GMP Certified

    Switzerland
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    WHO GMP Certified

    Switzerland
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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    • WHO-GMP
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    Hetero Drugs

    Name and address of WHO GMP certified Manufacturer : Hetero Labs Ltd, Unit-V, Sy.No. 410&411, APIIC Formulation SEZ, Polepally Village, Jedcherla Mandal, Mahaboobnagar

    Country : India

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    06

    WHO GMP Certified

    Switzerland
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    WHO GMP Certified

    Switzerland
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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Hetero Drugs

    Name and address of WHO GMP certified Manufacturer : Hetero Labs Ltd, Unit-VI, Sy.No. 410&411, APIIC Formulation SEZ, Polepally Village, Jedcherla Mandal, Mahaboobnagar

    Country : India

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    07

    WHO GMP Certified

    Switzerland
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    WHO GMP Certified

    Switzerland
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Name and address of WHO GMP certified Manufacturer : Hetero Labs Ltd, Unit-VI, Sy.No. 410&411, APIIC Formulation SEZ, Polepally Village, Jedcherla Mandal, Mahaboobnagar

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    Name and address of WHO GMP certified Manufacturer : Hetero Labs Ltd, Unit-VI, Sy.No. 410&411, APIIC Formulation SEZ, Polepally Village, Jedcherla Mandal, Mahaboobnagar

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    Hetero Drugs

    Name and address of WHO GMP certified Manufacturer : Hetero Labs Ltd, Unit-VI, Sy.No. 410&411, APIIC Formulation SEZ, Polepally Village, Jedcherla Mandal, Mahaboobnagar

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    Hetero Drugs

    Name and address of WHO GMP certified Manufacturer : Hetero Labs Ltd, Unit-VI, Sy.No. 410&411, APIIC Formulation SEZ, Polepally Village, Jedcherla Mandal, Mahaboobnagar

    Country : India

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    Hetero Drugs

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : HETERO DRUGS LIMITED

    Business Address : UNIT-IX, Plot No.1, Hetero I...

    FEI Number : 3009225386

    Country : India

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    Hetero Drugs

    API Manufacturer : API MANUFACTURE

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    Facility Name : HETERO DRUGS LIMITED

    Business Address : UNIT-I, Sy.No. 213, 214 and ...

    FEI Number : 3003510514

    Country : India

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    API Manufacturer : API MANUFACTURE

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    Facility Name : HETERO LABS LIMITED

    Business Address : Unit-I, Survey.No.10, I.D.A....

    FEI Number : 3004378446

    Country : India

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    Hetero Drugs

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : HETERO LABS LIMITED

    Business Address : UNIT-IX, Plot No.2, Hetero I...

    FEI Number : 3009093782

    Country : India

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    Hetero Drugs

    API Manufacturer :

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : Hetero Labs Limited Unit-III

    Business Address : Plot No. 22-110, Part-II, ID...

    FEI Number : 3005406526

    Country : India

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    Hetero Drugs

    API Manufacturer :

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : Hetero Labs Limited Unit-V

    Business Address : Sy. No. 439, 440, 441 & 458,...

    FEI Number : 3008307735

    Country : India

    Paid in : 2019

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    Contact Hetero Drugs and get a quotation

    Hetero Drugs is a supplier offers 495 products (APIs, Excipients or Intermediates).

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