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    Company profile for Hetero Drugs

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

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    Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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    xyz-pharma-m-2024-10-07

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    With Fermion, start the journey of your innovative API.

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    Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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    EVENTS

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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
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    +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  

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    16 Dec 2024
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    VLOG #PharmaReel

    [Sponsored by another company]

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

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

    Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397  Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17   13 37 Taiwan 9 6 5 4 24 Switzerland 15 4   4 23 France 16     6 22 Japan 18   1   19 United Kingdom 12 1   2 15 Mexico 9 1   1 11 Ireland 5 5   1 11   Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years. 
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    Impressions: 11518

    https://www.pharmacompass.com/radio-compass-blog/chinese-fda-registered-generic-facilities-gain-steam-india-maintains-lead-with-396-facilities

    #PharmaFlow by PHARMACOMPASS
    21 Nov 2024
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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

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    01

    Atomoxetin Hydrochloride

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

    Antibody Engineering
    Not Confirmed
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    Atomoxetin Hydrochloride

    India

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

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    Antibody Engineering
    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 : 2024-12-31

    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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    02

    Bicalutamide

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

    Antibody Engineering
    Not Confirmed
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    Bicalutamide

    India

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

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    Antibody Engineering
    Not Confirmed
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    • EDQM
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    ✖

    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 : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    03

    Escitalopram Oxalate

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

    Antibody Engineering
    Not Confirmed
    arrow

    Escitalopram Oxalate

    India

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

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    Antibody Engineering
    Not Confirmed
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    ✖

    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 : 2024-12-31

    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

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    04

    Irbesartan

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

    Antibody Engineering
    Not Confirmed
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    Irbesartan

    India

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

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    Antibody Engineering
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    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 : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    05

    Lamivudine

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

    Antibody Engineering
    Not Confirmed
    arrow

    Lamivudine

    India

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

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    Antibody Engineering
    Not Confirmed
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    • EDQM
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    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 : R1-CEP 2008-160 - Rev 02

    Issue Date : 2017-08-10

    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 : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    06

    Levetiracetam

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

    Antibody Engineering
    Not Confirmed
    arrow

    Levetiracetam

    India

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

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    Antibody Engineering
    Not Confirmed
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    ✖

    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 : 2024-12-31

    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

    07

    Lisinopril

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

    Antibody Engineering
    Not Confirmed
    arrow

    Lisinopril

    India

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

    arrow
    Antibody Engineering
    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
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    Market
    Place

    08

    Losartan Potassium

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

    Antibody Engineering
    Not Confirmed
    arrow

    Losartan Potassium

    India

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

    arrow
    Antibody Engineering
    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 : R1-CEP 2009-247 - Rev 08

    Issue Date : 2023-07-04

    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 : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    09

    Olanzapine

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

    Antibody Engineering
    Not Confirmed
    arrow

    Olanzapine

    India

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

    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
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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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    10

    Quetiapine Hemifumarate

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

    Antibody Engineering
    Not Confirmed
    arrow

    Quetiapine Hemifumarate

    India

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

    arrow
    Antibody Engineering
    Not Confirmed
    • fda
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-07-23

    Pay. Date : 2013-07-12

    DMF Number : 20845

    Submission : 2007-09-12

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-153 - Rev 02

    Issue Date : 2023-06-15

    Type : Chemical

    Substance Number : 2541

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10094

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

    Initial Date of Registration : 2016-04-27

    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 : 68554-0024

    Start Marketing Date : 1997-09-26

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Mirae Pharmchem Co., Ltd.

    Registration Date : 2021-07-05

    Registration Number : 20120816-172-I-120-06(2)

    Manufacturer Name : Hetero Labs Limited

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

     VMF Others AUDIT
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    USDMF

    read-more
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    01

    Abacavir Sulfate

    India
    Antibody Engineering
    Not Confirmed
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    02

    Abacavir Sulfate (process-ii), Usp

    India
    Antibody Engineering
    Not Confirmed
    arrow

    03

    Abiraterone Acetate

    India
    Antibody Engineering
    Not Confirmed
    arrow

    04

    Acyclovir

    India
    Antibody Engineering
    Not Confirmed
    arrow

    Acyclovir

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

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-01-09

    Pay. Date : 2012-12-10

    DMF Number : 25587

    Submission : 2011-12-13

    Status : Active

    Type : II

    blank

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    Market
    Place

    05

    Afatinib Dimaleate

    India
    Antibody Engineering
    Not Confirmed
    arrow

    06

    Afatinib Dimaleate (form A)

    India
    Antibody Engineering
    Not Confirmed
    arrow

    07

    Alectinib Hydrochloride

    India
    Antibody Engineering
    Not Confirmed
    arrow

    08

    Alfuzosin Hydrochloride

    India
    Antibody Engineering
    Not Confirmed
    arrow

    09

    Allopurinol

    India
    Antibody Engineering
    Not Confirmed
    arrow

    Allopurinol

    India
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
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    Hetero Drugs

    GDUFA

    DMF Review : Complete

    Rev. Date : 2021-03-17

    Pay. Date : 2020-12-17

    DMF Number : 35422

    Submission : 2020-12-21

    Status : Active

    Type : II

    blank

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    Market
    Place

    10

    Amifampridine Phosphate

    India
    Antibody Engineering
    Not Confirmed
    arrow
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    CEP/COS

    read-more
    read-more

    01

    Abacavir sulfate

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    02

    Aciclovir

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    03

    Allopurinol

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    04

    Amlodipine besilate

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    05

    Amlodipine besilate, Process II

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    06

    Anastrozole

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    07

    Aprepitant

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    08

    Aripiprazole, Process-II

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    09

    Aripiprazole, Type-I

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow

    10

    Atazanavir sulfate

    CEP/COS

    Antibody Engineering
    Not Confirmed
    arrow
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    JDMF

    read-more
    read-more

    01

    Abiraterone Acetate

    JDMF

    Antibody Engineering
    Not Confirmed
    arrow

    Abiraterone Acetate

    India
    arrow
    Antibody Engineering
    Not Confirmed
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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

    blank

    Product
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    Market
    Place

    02

    Abiraterone acetate

    JDMF

    Antibody Engineering
    Not Confirmed
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    Abiraterone acetate

    India
    arrow
    Antibody Engineering
    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
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    Market
    Place

    03

    Amlodipine besylate

    JDMF

    Antibody Engineering
    Not Confirmed
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    Amlodipine besylate

    India
    arrow
    Antibody Engineering
    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
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    04

    Amlodipine besylate "F"

    JDMF

    Antibody Engineering
    Not Confirmed
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    Amlodipine besylate "F"

    India
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    Antibody Engineering
    Not Confirmed
    • fda
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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
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    05

    Anastrozole

    JDMF

    Antibody Engineering
    Not Confirmed
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    Anastrozole

    India
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • 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
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    06

    Apremi last

    JDMF

    Antibody Engineering
    Not Confirmed
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    Apremi last

    India
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    Antibody Engineering
    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

    Antibody Engineering
    Not Confirmed
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    Aripiprazole

    India
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
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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

    Antibody Engineering
    Not Confirmed
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    Aripiprazole

    India
    arrow
    Antibody Engineering
    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
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    09

    Atomoxetine hydrochloride

    JDMF

    Antibody Engineering
    Not Confirmed
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    Atomoxetine hydrochloride

    India
    arrow
    Antibody Engineering
    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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    10

    Atorvastatin calcium hydrate [Form-I]

    JDMF

    Antibody Engineering
    Not Confirmed
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    Atorvastatin calcium hydrate [Form-I]

    India
    arrow
    Antibody Engineering
    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
    Antibody Engineering
    Not Confirmed
    arrow

    02

    Abacavir Sulfate (USP)

    India
    Antibody Engineering
    Not Confirmed
    arrow

    03

    Abacavir Sulphate USP

    India
    Antibody Engineering
    Not Confirmed
    arrow

    04

    Abacavir Sulfate (USP)

    India
    Antibody Engineering
    Not Confirmed
    arrow

    05

    Abiraterone Acetate IH/USP

    India
    Antibody Engineering
    Not Confirmed
    arrow

    06

    Acyclovir (USP)

    India
    Antibody Engineering
    Not Confirmed
    arrow

    07

    Adefovir Dipivoxil (IH)

    India
    Antibody Engineering
    Not Confirmed
    arrow

    08

    Afatinib Dimaleate IH

    India
    Antibody Engineering
    Not Confirmed
    arrow

    09

    Afatinib Dimaleate IH

    India
    Antibody Engineering
    Not Confirmed
    arrow

    10

    Alfuzosin Hydrochloride (USP...

    India
    Antibody Engineering
    Not Confirmed
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    Contact Hetero Drugs and get a quotation

    Hetero Drugs is a supplier offers 493 products (APIs, Excipients or Intermediates).

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