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    Company profile for Hetero Drugs

    Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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    Kewpie is your partner for Sodium Hyaluronate & Hyaluronic Acid// CEP, USDMF, KDMF & JDMF registered.

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    Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.

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    AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical 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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    7-2-A2, Hetero Corporate Industrial Estates, Sanath Nagar Hyderabad,Telangana
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    +91 40 23704923/24
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”

    “Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”

    This week, SpeakPharma interviews Pete Werth III, the new president of ChemWerth, a company that has been at the forefront of the generic pharmaceutical industry for over four decades. He shares his vision for ChemWerth, which includes his commitment to strengthening global manufacturing relationships, and enhancing supply chain resilience. Additionally, he highlights the key aspects of a successful drug master file (DMF). HIGHLIGHTS// Pete Werth III, the new president of ChemWerth/ vision for ChemWerth/ commitment to strengthening global manufacturing relationships/ key aspects of a successful drug master file Your father, Peter J. Werth, is recognized as one of the founders of the generic pharmaceutical industry, having built ChemWerth from the ground up over four decades ago. How do you view his legacy? As you take the helm, what key lessons or principles from his leadership do you intend to carry forward? My father, Peter J. Werth, is a true pioneer in the generic pharmaceutical industry. Over his 42‐year tenure, he not only built ChemWerth from a humble garage startup into a global leader in generic API development but also established standards that many in our industry now take for granted. Under his leadership, we filed our very first DMF in 1987 and have since achieved more than 500 DMF filings. With an average review cycle of just 0.79, we have been far outperforming the industry average of 2.5 cycles. His focus on quality, regulatory excellence, and a relentless commitment to customers’ success set the foundation for our reputation as a trusted supplier of over 500 APIs sourced from more than 30 cGMP-certified facilities worldwide. Equally inspiring is his dedication to nurture long-term, mutually beneficial relationships with manufacturing partners across the US, Europe, India, and China, as well as his passion for giving back to the community through philanthropic initiatives. As I take the helm, I intend to build on his guiding principles — sustaining our high standards of quality and compliance while pursuing innovation in regulatory strategy, diversifying our supply chain, and embracing new technologies and approaches to remain competitive in an evolving market. I will also strive to continue his legacy of mentorship, ensuring that our company culture remains rooted in integrity and diligence, with an unyielding focus on making safe, affordable medicines available worldwide. HIGHLIGHTS// trusted supplier of over 500 APIs/ 30 cGMP-certified facilities worldwide/ embracing new technologies and approaches to remain competitive What are your top priorities as the new president of ChemWerth? How do you plan to strengthen and expand relationships with manufacturers worldwide? My immediate priorities as the new president are twofold: to enhance the value we deliver to our customers and, to deepen our relationships with our manufacturing partners worldwide. We will further diversify our supply chain and broaden our product portfolio. Our expansion plans include upgrading equipment, and hiring additional highly skilled scientists, engineers, and GMP auditors. We will also leverage our proprietary product selection and regulatory submission processes. These processes help us get the regulatory filing right the first time, and allows us to be approved 44 percent faster than the industry average. This helps our customers gain a competitive edge in the market. In essence, by strengthening operational excellence and expanding our global network, we intend to continue the company’s long-standing commitment to customer success and process innovation. We plan to reinforce our long-standing relationships with our manufacturers — especially those in strategic markets like China and India — by helping our partners meet the highest standards of regulatory compliance and current good manufacturing practice (cGMP) quality. This balanced approach of strengthening existing partnerships while pioneering new ones is key to maintaining and growing our competitive edge. HIGHLIGHTS// diversify our supply chain and broaden our product portfolio/ commitment to customer success and process innovation/ filings approved 44 percent faster than the industry average When ChemWerth last spoke to PharmaCompass, there was a mention of investing millions of dollars in expanding manufacturing partnerships in China and India. Can you elaborate on the success of these partnerships, and how have they contributed to ChemWerth’s overall growth? Our strategic, multimillion-dollar investments in manufacturing partnerships are a cornerstone of our growth strategy. Over the past few years, these joint ventures have proven their worth by diversifying our supply base and mitigating the risk of global supply chain disruptions — a lesson that became all too clear during the Covid-19 pandemic. These investments are already paying dividends. They help us support manufacturers producing steroids, hormones, veterinary products, and large-volume APIs, while also accelerating the development of small-molecule inhibitors and new generic APIs. We have ensured that our partners are equipped with the latest equipment and trained personnel to meet cGMP standards. By partnering with facilities in these markets, we now have access to state-of-the-art production capabilities that enable us to produce a wider range of APIs at competitive costs. The success of these partnerships is evident in our ability to consistently file DMFs rapidly — often on the first cycle — and deliver affordable, high-quality medicines to patients worldwide. This supports our clients’ growth trajectory and has helped us expand into new markets. This strategy has reinforced our global footprint — supporting our presence in 38 countries with over 100 products — and positioned us well to capitalize on a global generic drug market projected to grow at a compounded annual growth rate of 5.4 percent from 2022 to 2030, to reach a size of US$ 671 billion by 2030. HIGHLIGHTS// strategic multimillion-dollar investments/ support manufacturers producing steroid, hormone, veterinary products/ development of small-molecule inhibitors and new generic APIs/ ensured partners are equipped with the latest equipment and trained personnel ChemWerth has an impressive track record, and an over 40-year relationship with the US Food and Drug Administration (FDA). What are the key aspects of a successful DMF? Are there specific challenges manufacturers face in preparing DMFs, and how does ChemWerth help them overcome these hurdles? ChemWerth’s record of filing over 500 DMFs in 38 countries reflects our commitment to excellence in regulatory compliance and quality management. A successful DMF is built on comprehensive documentation that rigorously follows cGMP guidelines, robust analytical validation, and detailed tracking of every step. Every DMF we file meticulously details the entire manufacturing process — from raw material acquisition to final batch production. This comprehensive approach ensures that our submissions meet the rigorous quality, safety, and efficacy standards expected by the FDA. Our team stays continuously updated on the evolving guidelines and protocols, which allows us to file DMFs that align with current FDA practices. We recognize that many manufacturers face challenges such as complex regulatory requirements, lengthy review cycles, and the need for precise coordination between various production stages. ChemWerth helps them overcome these hurdles by offering end-to-end regulatory support, detailed internal audits, and continuous training on cGMP and FDA requirements. Our efficiency is a critical competitive advantage. By receiving approvals 44 percent faster than the industry average, we help our customers get their products to market faster, resulting in larger market share and increased profits. HIGHLIGHTS// over 500 DMFs in 38 countries/ robust analytical validation/ end-to-end regulatory support What is your vision for ChemWerth over the next few years? How do you plan to navigate the challenges and opportunities in the generic pharmaceutical industry? I plan to continue to add value for our customers, and look for innovative ways to compete in today’s generic pharmaceutical landscape. At ChemWerth, our vision for the future is rooted in both our proud legacy and our relentless drive for innovation. We will further diversify our supply chain and expand our product portfolio. We have begun leveraging our expertise to supply APIs for biosimilars and new drug applications (NDAs), while maintaining our reputation for rapid regulatory approvals. With unwavering determination, we uphold our “First to Quality. Fast to Market.” approach — delivering high-quality APIs to customers worldwide while leveraging our expertise to give them a competitive edge in their markets. HIGHLIGHTS// supply APIs for biosimilars and NDAs/ give customers a competitive edge in their markets 

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    Radio Compass
    12 Mar 2025
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    [Sponsored by another company]
    Molecular glue degraders: Lilly, AbbVie sign billion-dollar deals; BMS leads with three late-stage drugs

    Molecular glue degraders: Lilly, AbbVie sign billion-dollar deals; BMS leads with three late-stage drugs

    This week, we delve into molecular glue degraders (MGDs), one of the most promising frontiers in drug development. MGDs address a vast number of previously “undruggable” disease-causing proteins.Unlike traditional small molecule drugs that require specific binding pockets, MGDs function by enhancing protein-protein interactions. MGDs selectively target disease-causing proteins and an enzyme known as E3 ubiquitin ligase. By creating a binding interface between the two, MGDs  destroy the target proteins.Another kind of degraders are proteolysis targeting chimeras (PROTACs) that use a bifunctional approach — one binds the target proteins, and the other binds to an E3 ligases together. These degraders induce the degradation of specific proteins by using the cell’s natural ubiquitin-proteasome system (a process in cells where damaged or unneeded proteins are tagged by a small molecule called ubiquitin and then broken down by a structure called the proteasome so that cells stay healthy and function properly).MGDs constitute a rapidly growing market, where both the targeted protein degradation technologies and investment in research and development are witnessing growth.Currently, the most recognized molecular glues are the immunomodulatory imide drugs (IMiDs), such as thalidomide, lenalidomide and pomalidomide, which have been around for some time. According to GlobalData, lenalidomide generated over US$ 6 billion in sales in 2023, thereby demonstrating the commercial viability of this therapeutic approach.Lilly, AbbVie ink billion-dollar MGD deals; Biogen partners Neomorph; Pfizer, Triana ink collaborationThe MGD space has witnessed extraordinary deal-making activity over the recent months, with major pharmaceutical companies committing billions of dollars to secure access to novel MGD platforms and pipelines. This surge in investment reflects the industry’s growing confidence in the therapeutic potential of MGDs to address previously undruggable targets.This year has already seen two landmark deals. In February, Magnet Biomedicine entered into a collaboration and license agreement with Eli Lilly worth up to US$ 1.29 billion to discover and develop novel MGDs. This partnership leverages Magnet’s TrueGlue discovery platform and approach with Lilly’s expertise in the development of small molecule therapeutics. In January, AbbVie crafted a US$ 1.64 billion deal with molecular glue biotech Neomorph, combining AbbVie’s oncology and immunology drug development capabilities with Neomorph's leading molecular glue discovery platform.While oncology remains the primary focus, these collaborations are increasingly expanding into neurodegenerative diseases, immunological disorders, and other therapeutic areas. For instance, in October, Biogen and Neomorph announced a multi-target research collaboration to discover and develop MGDs for Alzheimer’s, rare neurological, and immunological diseases, potentially worth up to US$ 1.45 billion.October also saw Novartis sign a potential US$ 2.25 billion deal with Monte Rosa Therapeutics. The deal gives Novartis exclusive worldwide rights to develop, manufacture and commercialize multiple MGDs (including MRT-6160) for undruggable targets, including in the areas of immunology and inflammation, metabolism, and genetic diseases.Earlier in October, Triana Biomedicines and Pfizer entered into a research collaboration to discover novel MGDs for multiple targets across several disease areas, including oncology, with a total potential value of up to US$ 1.55 billion.And in August 2024, SEED Therapeutics entered into a strategic research collaboration with Eisai to discover and develop novel MGDs for neurodegenerative and oncological indications, potentially worth up to US$ 1.5 billion.BMS leads with three MGDs in late-stage trials; Monte Rosa’s MRT-2359 targets solid tumorsBristol Myers Squibb has established itself as a leader in the clinical development of MGDs with three products in late-stage development. These include a next-gen MGD mezigdomide (CC-92480), which is currently in phase 3 trials in combination with carfilzomib and dexamethasone for relapsed/refractory multiple myeloma. Another candidate is golcadomide, which is in late-stage clinical trials for high-risk first-line large B-cell lymphoma. And the third MGD in BMS’ portfolio is iberdomide, which has reached phase 3 development for multiple myeloma.Monte Rosa Therapeutics has made significant progress with MRT-2359, an investigational MGD that is currently in phase 1/2 clinical trials for the treatment of patients with MYC-driven solid tumors, including non-small cell lung cancer, small cell lung cancer, and high-grade neuroendocrine cancer. Myelocytomatosis or MYC is a gene which causes various solid tumors when overactive.MRT-2359 represents an important advancement in extending the molecular glue approach beyond hematological malignancies to solid tumors, which have historically proven more challenging to address with protein degradation strategies.Other significant early-stage candidates are Nested Therapeutics’ NST-628 and Plexium's PLX-4545. NST-628 relies on a novel mechanism of action in its category of RAS-MAPK inhibitors, and overcomes some traditional limitations in the treatment of cancers.PLX-4545 is Plexium’s first small molecule degrader program to enter clinical development. This potent and selective MGD of a classically undruggable transcription factor, also known as Helios (IKZF2), explores treating solid tumors. Transcription factors are proteins that regulate gene expression by binding to specific DNA sequences.Boehringer’s KRAS degrader advances PROTACs approach; Arvinas tests ARV-102 for neurodegenerative diseasesLike MGDs, PROTACs are also witnessing advancements in both R&D and dealmaking. For instance, BridGene Biosciences recently expanded its strategic collaboration with Galapagos to develop a selective oral SMARCA2 PROTAC in precision oncology. The SMARCA2 gene provides instructions for making one piece (subunit) of a group of similar protein complexes known as SWI/SNF complexes.In the clinical arena, Prelude Therapeutics announced a collaboration with Merck to evaluate PRT3789 in combination with Keytruda (pembrolizumab) in patients with SMARCA4-mutated cancers. PRT3789 is a potent and highly selective, first-in-class SMARCA2 degrader.On the molecular front, ACBI3, a novel pan-KRAS degrader developed through a collaboration between the University of Dundee and Boehringer Ingelheim, addresses a critical gap in cancer therapy by targeting 13 out of 17 prevalent KRAS mutants. KRAS mutation is a change in the KRAS gene, a common gene that can cause cancer. ACBI3’s development is a potential breakthrough for millions of cancer patients with KRAS-driven tumors.Vepdegestrant (ARV-471), a collaborative effort between Arvinas and Pfizer, remains the most advanced PROTAC candidate to date and has met its primary endpoint in a late-stage study in breast cancer patients with estrogen receptor 1 mutations.  Similarly, Arvinas’ ARV-102 became the first PROTAC to be tested in humans for neurodegenerative diseases, marking a significant milestone in addressing brain-related disorders.Our viewMGDs offer a new, and groundbreaking approach to treating cancers and various other diseases, thereby attracting substantial investments by major pharmaceutical companies. As clinical trials show encouraging results, we expect investments in the MGDs space to increase even further. 
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    https://www.pharmacompass.com/radio-compass-blog/molecular-glue-degraders-lilly-abbvie-sign-billion-dollar-deals-bms-leads-with-three-late-stage-drugs

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    27 Mar 2025
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    NEWS #PharmaBuzz

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    Hetero`s Generics Eltrombopag Olamine Receives Approval in US
    Hetero`s Generics Eltrombopag Olamine Receives Approval in US

    17 Jan 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206788

    FDA
    17 Jan 2025
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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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    ALL APIs

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

    01

    Atomoxetin Hydrochloride

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

    ELCC
    Not Confirmed
    arrow

    Atomoxetin Hydrochloride

    India

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

    arrow
    ELCC
    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 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 : R0-CEP 2020-091 - Rev 01

    Issue Date : 2021-03-19

    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 : Hansol Pharma Co., Ltd.

    Registration Date : 2014-09-19

    Registration Number : No. 3838-3-ND(5)

    Manufacturer Name : Hetero Labs Limited

    Manufacturer Address : Survey No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, SangaReddy District-502319, Telangana, INDIA

     VMF Others AUDIT
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    Market
    Place

    02

    Bicalutamide

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

    ELCC
    Not Confirmed
    arrow

    Bicalutamide

    India

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

    arrow
    ELCC
    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 : 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
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    03

    Escitalopram Oxalate

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

    ELCC
    Not Confirmed
    arrow

    Escitalopram Oxalate

    India

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

    arrow
    ELCC
    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 : 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 : CEP 2017-080 - Rev 06

    Issue Date : 2023-10-27

    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 : Hanlim Pharmaceutical Co., Ltd.

    Registration Date : 2019-04-12

    Registration Number : 20180604-209-J-223(5)

    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
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    04

    Finasteride

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

    ELCC
    Not Confirmed
    arrow

    Finasteride

    India

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

    arrow
    ELCC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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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
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    05

    Irbesartan

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

    ELCC
    Not Confirmed
    arrow

    Irbesartan

    India

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

    arrow
    ELCC
    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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    Place

    06

    Lamivudine

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

    ELCC
    Not Confirmed
    arrow

    Lamivudine

    India

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

    arrow
    ELCC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    ✖

    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 : CEP 2013-168 - Rev 01

    Issue Date : 2024-05-02

    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

    ELCC
    Not Confirmed
    arrow

    Levetiracetam

    India

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

    arrow
    ELCC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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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 : 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

    ELCC
    Not Confirmed
    arrow

    Lisinopril

    India

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

    arrow
    ELCC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    ✖

    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 : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

    Product
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    #PipelineProspector

    Market
    Place

    09

    Losartan Potassium

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

    ELCC
    Not Confirmed
    arrow

    Losartan Potassium

    India

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

    arrow
    ELCC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    ✖

    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

    Product
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    #PipelineProspector

    Market
    Place

    10

    Olanzapine

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

    ELCC
    Not Confirmed
    arrow

    Olanzapine

    India

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

    arrow
    ELCC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    ✖

    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 : 2025-12-31

    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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    Market
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    USDMF

    read-more
    read-more

    01

    Abacavir Sulfate

    India
    ELCC
    Not Confirmed
    arrow

    02

    Abacavir Sulfate (process-ii), Usp

    India
    ELCC
    Not Confirmed
    arrow

    03

    Abiraterone Acetate

    India
    ELCC
    Not Confirmed
    arrow

    04

    Acyclovir

    India
    ELCC
    Not Confirmed
    arrow

    05

    Afatinib Dimaleate

    India
    ELCC
    Not Confirmed
    arrow

    06

    Afatinib Dimaleate (form A)

    India
    ELCC
    Not Confirmed
    arrow

    07

    Alectinib Hydrochloride

    India
    ELCC
    Not Confirmed
    arrow

    08

    Alfuzosin Hydrochloride

    India
    ELCC
    Not Confirmed
    arrow

    09

    Allopurinol

    India
    ELCC
    Not Confirmed
    arrow

    10

    Amifampridine Phosphate

    India
    ELCC
    Not Confirmed
    arrow
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    CEP/COS

    read-more
    read-more

    01

    Abacavir sulfate

    CEP/COS

    ELCC
    Not Confirmed
    arrow

    02

    Aciclovir

    CEP/COS

    ELCC
    Not Confirmed
    arrow

    03

    Allopurinol

    CEP/COS

    ELCC
    Not Confirmed
    arrow

    04

    Amlodipine besilate

    CEP/COS

    ELCC
    Not Confirmed
    arrow

    05

    Amlodipine besilate, Process II

    CEP/COS

    ELCC
    Not Confirmed
    arrow

    06

    Anastrozole

    CEP/COS

    ELCC
    Not Confirmed
    arrow

    07

    Aprepitant

    CEP/COS

    ELCC
    Not Confirmed
    arrow

    08

    Aripiprazole, Type-I

    CEP/COS

    ELCC
    Not Confirmed
    arrow

    09

    Atazanavir sulfate

    CEP/COS

    ELCC
    Not Confirmed
    arrow

    10

    Atomoxetine hydrochloride

    CEP/COS

    ELCC
    Not Confirmed
    arrow
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    JDMF

    read-more
    read-more

    01

    Abiraterone Acetate

    JDMF

    ELCC
    Not Confirmed
    arrow

    Abiraterone Acetate

    India
    arrow
    ELCC
    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

    ELCC
    Not Confirmed
    arrow

    Abiraterone acetate

    India
    arrow
    ELCC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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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

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    Market
    Place

    03

    Amlodipine besylate

    JDMF

    ELCC
    Not Confirmed
    arrow

    Amlodipine besylate

    India
    arrow
    ELCC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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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

    ELCC
    Not Confirmed
    arrow

    Amlodipine besylate "F"

    India
    arrow
    ELCC
    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
    Place

    05

    Anastrozole

    JDMF

    ELCC
    Not Confirmed
    arrow

    Anastrozole

    India
    arrow
    ELCC
    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

    ELCC
    Not Confirmed
    arrow

    Apremi last

    India
    arrow
    ELCC
    Not Confirmed
    • fda
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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

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    Market
    Place

    07

    Aripiprazole

    JDMF

    ELCC
    Not Confirmed
    arrow

    Aripiprazole

    India
    arrow
    ELCC
    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

    ELCC
    Not Confirmed
    arrow

    Aripiprazole

    India
    arrow
    ELCC
    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

    ELCC
    Not Confirmed
    arrow

    Atomoxetine hydrochloride

    India
    arrow
    ELCC
    Not Confirmed
    • fda
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    • WHO-GMP
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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
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    10

    Atorvastatin calcium hydrate [Form-I]

    JDMF

    ELCC
    Not Confirmed
    arrow

    Atorvastatin calcium hydrate [Form-I]

    India
    arrow
    ELCC
    Not Confirmed
    • fda
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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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    KDMF

    read-more
    read-more

    01

    Abiraterone acetate

    India
    ELCC
    Not Confirmed
    arrow

    Abiraterone acetate

    India
    arrow
    ELCC
    Not Confirmed
    • fda
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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
    ELCC
    Not Confirmed
    arrow

    Abiraterone acetate

    India
    arrow
    ELCC
    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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    Amlodipine besilate

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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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    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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    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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    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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    07

    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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    Amlodipine besilate

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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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    09

    Amlodipine besilate

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    Hetero Drugs

    Registrant Name : Sungwoo Chemical Co., Ltd.

    Registration Date : 2016-04-19

    Registration Number : 20120120-130-H-183-36(4)

    Manufacturer Name : Hetero Drugs Limited

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

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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

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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

    ABEMACICLIB

    India
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    Hetero Drugs

    NDC Package Code : 68554-0173

    Start Marketing Date : 2017-09-28

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    04

    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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    05

    ACYCLOVIR

    India
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    ACYCLOVIR

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    Hetero Drugs

    NDC Package Code : 65977-0058

    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

    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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    07

    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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    08

    ALECTINIB HYDROCHLORIDE

    India
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    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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    ALFUZOSIN HYDROCHLORIDE

    India
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    Hetero Drugs

    NDC Package Code : 65977-0023

    Start Marketing Date : 2003-12-06

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    ALLOPURINOL

    India
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    ALLOPURINOL

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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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    EDQM

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    GMP Certified

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    Hetero Drugs

    Type : GMP Certificates

    Number : 15/08782-9

    EudraGMDP Key : 37990

    Country : India

    Issue Date : 2016-01-08

    Post Code : Pin-509301

    NCA Ref : 379901452062...

    City : TELANGANA

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    02

    GMP Certified

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    Hetero Drugs

    Type : GMP Certificates

    Number : DE_BE_01_GM...

    EudraGMDP Key : 37672

    Country : India

    Issue Date : 2015-11-23

    Post Code : 502313

    NCA Ref : 00023335

    City : Medak - District, Bonth...

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    03

    GMP Certified

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    Hetero Drugs

    Type : GMP Certificates

    Number : DE_BE_01_GM...

    EudraGMDP Key : 37707

    Country : India

    Issue Date : 2015-11-23

    Post Code : PIN - 500 055

    NCA Ref : 00023323

    City : Telangana

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    04

    GMP Certified

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    Hetero Drugs

    Type : GMP Certificates

    Number : DE_BE_01_GM...

    EudraGMDP Key : 37706

    Country : India

    Issue Date : 2015-11-23

    Post Code : 502319

    NCA Ref : 00023331

    City : Medak District, Gaddapo...

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    05

    GMP Certified

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    GMP Certified

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    Hetero Drugs

    Type : GMP Certificates

    Number : DE_BE_01_GM...

    EudraGMDP Key : 37706

    Country : India

    Issue Date : 2015-11-23

    Post Code : 502319

    NCA Ref : 00023331

    City : Medak District, Gaddapo...

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    06

    GMP Certified

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    GMP Certified

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    Hetero Drugs

    Type : GMP Certificates

    Number : DE_BE_01_GM...

    EudraGMDP Key : 37672

    Country : India

    Issue Date : 2015-11-23

    Post Code : 502313

    NCA Ref : 00023335

    City : Medak - District, Bonth...

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    07

    GMP Certified

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    Hetero Drugs

    Type : GMP Certificates

    Number : DK API-H 00...

    EudraGMDP Key : 18133

    Country : India

    Issue Date : 2015-02-24

    Post Code : 502313

    NCA Ref : S.No.s 213, ...

    City : Jinneram Mandal

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    08

    GMP Certified

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    Hetero Drugs

    Type : GMP Certificates

    Number : MT/002HM/20...

    EudraGMDP Key : 23591

    Country : Malta

    Issue Date : 2014-02-25

    Post Code : PLA3000

    NCA Ref : 235911392908...

    City : Paola

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    GMP Certified

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    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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    10

    GMP Certified

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    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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    ABOUT THIS PAGE

    Contact HETERO DRUGS LTD and get a quotation

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