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    Company profile for Viatris

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

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    Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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    LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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    Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.

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    About

    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to co...
    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.

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    Robert J. Coury Global Center 1000 Mylan Blvd. Canonsburg, PA 15317
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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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    VLOG #PharmaReel

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    DATA COMPILATION #PharmaFlow

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    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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    Impressions: 313

    https://www.pharmacompass.com/radio-compass-blog/molecular-glue-degraders-lilly-abbvie-sign-billion-dollar-deals-bms-leads-with-three-late-stage-drugs

    #Phispers by PHARMACOMPASS
    27 Mar 2025
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    NEWS #PharmaBuzz

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    Mylan Labs is on Health Canada Inspection List
    Mylan Labs is on Health Canada Inspection List

    18 Mar 2025

    // HEALTH CANADA

    https://www.pharmacompass.com/pdf/news/mylan-labs-is-on-health-canada-inspection-list-99723.pdf

    HEALTH CANADA
    18 Mar 2025
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    Viatris to Present at Barclays Global Healthcare Conference
    Viatris to Present at Barclays Global Healthcare Conference

    05 Mar 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/viatris-to-present-at-the-barclays-27th-annual-global-healthcare-conference-302393671.html

    PR NEWSWIRE
    05 Mar 2025
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    Viatris Reports Fourth Quarter and Full Year 2024
    Viatris Reports Fourth Quarter and Full Year 2024

    27 Feb 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/viatris-reports-fourth-quarter-and-full-year-2024-financial-results-and-provides-2025-financial-guidance-302386887.html

    PR NEWSWIRE
    27 Feb 2025
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    Nxera Assigns Japan, APAC Rights For Cenerimod To Viatris
    Nxera Assigns Japan, APAC Rights For Cenerimod To Viatris

    27 Feb 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/02/28/3034436/0/en/Nxera-Pharma-Assigns-Japan-and-APAC-ex-China-Rights-to-Cenerimod-for-Autoimmune-Diseases-to-Viatris.html

    GLOBENEWSWIRE
    27 Feb 2025
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    Idorsia, Viatris update collaboration for selatogrel, cenerimod
    Idorsia, Viatris update collaboration for selatogrel, cenerimod

    26 Feb 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/02/26/3032551/0/en/Idorsia-and-Viatris-update-their-collaboration-for-selatogrel-and-cenerimod.html

    GLOBENEWSWIRE
    26 Feb 2025
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    Pfizer Partners with Mylan to Boost Ativan & Pacitane Sales
    Pfizer Partners with Mylan to Boost Ativan & Pacitane Sales

    24 Feb 2025

    // INDIAINFOLINE

    https://www.indiainfoline.com/news/business/pfizer-partners-with-mylan-to-boost-ativan-and-pacitane-sales-in-india

    INDIAINFOLINE
    24 Feb 2025
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    ALL APIs

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    01

    Aciclovir

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

    Immuno-Oncology 360
    Not Confirmed
    arrow

    Aciclovir

    U.S.A

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

    arrow
    Immuno-Oncology 360
    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 : Reviewed

    Rev. Date : 2012-12-26

    Pay. Date : 2012-11-19

    DMF Number : 13277

    Submission : 1998-10-22

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 218MF10974

    Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India

    Initial Date of Registration : 2006-12-01

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-22

    Valid Till : 2025-07-28

    Written Confirmation Number : WC-0117

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65015-600

    Start Marketing Date : 2015-01-20

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Bukwang Pharmaceutical Co., Ltd.

    Registration Date : 2018-05-04

    Registration Number : 20050831-33-A-83-09(3)

    Manufacturer Name : Mylan Laboratories Limited

    Manufacturer Address : 14, 99 & 100, Industrial Development Area Pashamylaram, Phase-II, Patancheru, 502 307, Medak District, Telangana, India

     VMF Others AUDIT
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    Web Link

    Stock Recap
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    Market
    Place

    02

    Febuxostat

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

    Immuno-Oncology 360
    Not Confirmed
    arrow

    Febuxostat

    U.S.A

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

    arrow
    Immuno-Oncology 360
    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 : 2013-03-22

    Pay. Date : 2013-01-07

    DMF Number : 26657

    Submission : 2013-01-15

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 230MF10138

    Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India

    Initial Date of Registration : 2018-10-01

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-22

    Valid Till : 2025-07-28

    Written Confirmation Number : WC-0117

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65015-820

    Start Marketing Date : 2015-08-20

    End Marketing Date : 2026-12-01

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    03

    Irbesartan

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

    Immuno-Oncology 360
    Not Confirmed
    arrow

    Irbesartan

    U.S.A

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

    arrow
    Immuno-Oncology 360
    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 : 17912

    Submission : 2004-12-20

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 228MF10138

    Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India

    Initial Date of Registration : 2016-07-27

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-22

    Valid Till : 2025-07-28

    Written Confirmation Number : WC-0117

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    #PipelineProspector

    Market
    Place

    04

    Itraconazole

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

    Immuno-Oncology 360
    Not Confirmed
    arrow

    Itraconazole

    U.S.A

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

    arrow
    Immuno-Oncology 360
    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 : 2013-02-27

    Pay. Date : 2013-02-06

    DMF Number : 17739

    Submission : 2004-10-08

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 219MF10105

    Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India

    Initial Date of Registration : 2007-03-23

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-22

    Valid Till : 2025-07-28

    Written Confirmation Number : WC-0117

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65015-624

    Start Marketing Date : 2015-01-28

    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
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    05

    Lansoprazole

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

    Immuno-Oncology 360
    Not Confirmed
    arrow

    Lansoprazole

    U.S.A

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

    arrow
    Immuno-Oncology 360
    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 : 2015-11-16

    Pay. Date : 2015-11-06

    DMF Number : 19555

    Submission : 2006-06-27

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 227MF10198

    Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India

    Initial Date of Registration : 2015-08-06

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-22

    Valid Till : 2025-07-28

    Written Confirmation Number : WC-0117

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 65015-658

    Start Marketing Date : 2015-01-29

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    06

    Rizatriptan Benzoate

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

    Immuno-Oncology 360
    Not Confirmed
    arrow

    Rizatriptan Benzoate

    U.S.A

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

    arrow
    Immuno-Oncology 360
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-09-11

    Pay. Date : 2015-09-03

    DMF Number : 19098

    Submission : 2006-01-10

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 227MF10282

    Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India

    Initial Date of Registration : 2015-12-15

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-22

    Valid Till : 2025-07-28

    Written Confirmation Number : WC-0117

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65015-653

    Start Marketing Date : 2015-01-28

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    07

    Rosuvastatin Calcium

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

    Immuno-Oncology 360
    Not Confirmed
    arrow

    Rosuvastatin Calcium

    U.S.A

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

    arrow
    Immuno-Oncology 360
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-02-07

    Pay. Date : 2014-02-04

    DMF Number : 23766

    Submission : 2010-04-27

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 228MF10114

    Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India

    Initial Date of Registration : 2016-06-17

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-22

    Valid Till : 2025-07-28

    Written Confirmation Number : WC-0117

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65015-752

    Start Marketing Date : 2015-01-28

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    08

    Valacyclovir Hydrochloride

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

    Immuno-Oncology 360
    Not Confirmed
    arrow

    Valacyclovir Hydrochloride

    U.S.A

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

    arrow
    Immuno-Oncology 360
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-08-13

    Pay. Date : 2019-08-09

    DMF Number : 17943

    Submission : 2004-12-29

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 224MF10156

    Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India

    Initial Date of Registration : 2012-08-16

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-22

    Valid Till : 2025-07-28

    Written Confirmation Number : WC-0117

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65015-629

    Start Marketing Date : 2015-01-28

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Pharma Science Korea Co., Ltd.

    Registration Date : 2022-10-31

    Registration Number : 20221031-209-J-1353

    Manufacturer Name : Mylan Laboratories Limited (Unit-7)

    Manufacturer Address : Plot No. 14, 99 & 100, IDA, Pashamylaram Phase-II, Patancheru, Sangareddy District 502307, Telangana State, India

     VMF Others AUDIT
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    09

    Allopurinol

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

    Immuno-Oncology 360
    Not Confirmed
    arrow

    Allopurinol

    U.S.A

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

    arrow
    Immuno-Oncology 360
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16409

    Submission : 2003-04-23

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 217MF10578

    Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India

    Initial Date of Registration : 2005-09-14

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-06-03

    Valid Till : 2022-06-02

    Written Confirmation Number : WC-0015

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65015-606

    Start Marketing Date : 2015-02-12

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    10

    Lamivudine

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

    Immuno-Oncology 360
    Not Confirmed
    arrow

    Lamivudine

    U.S.A

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

    arrow
    Immuno-Oncology 360
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-08-28

    Pay. Date : 2013-08-20

    DMF Number : 17750

    Submission : 2004-10-08

    Status : Active

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R1-CEP 2011-044 - Rev 01

    Issue Date : 2017-10-25

    Type : Chemical

    Substance Number : 2217

    Status : Withdrawn by Holder

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-07-25

    Written Confirmation Number : WC-0189n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65015-701

    Start Marketing Date : 2015-01-13

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : GlaxoSmithKline Inc.

    Registration Date : 2020-03-05

    Registration Number : 20200305-209-J-420

    Manufacturer Name : Mylan Laboratories Limited (Unit 2)

    Manufacturer Address : Survey No. 10 & 42, Gaddapotharam(V) Kazipally Industrial Area Jinnaram Mandal Sangareddy District – 502319 Telangana State, India

     VMF Others AUDIT
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    USDMF

    read-more
    read-more

    01

    (s)-pregabalin

    U.S.A
    ASPEN
    Not Confirmed
    arrow

    02

    Abacavir Sulfate Usp

    U.S.A
    ASPEN
    Not Confirmed
    arrow

    03

    Abaloparatide

    U.S.A
    ASPEN
    Not Confirmed
    arrow

    04

    Abametapir

    U.S.A
    ASPEN
    Not Confirmed
    arrow

    05

    Acyclovir Usp

    U.S.A
    ASPEN
    Not Confirmed
    arrow

    06

    Adefovir Dipivoxil

    U.S.A
    ASPEN
    Not Confirmed
    arrow

    07

    Alendronate Sodium Usp (trihydrate)

    U.S.A
    ASPEN
    Not Confirmed
    arrow

    08

    Allopurinol Usp

    U.S.A
    ASPEN
    Not Confirmed
    arrow

    09

    Almotriptan Malate Usp

    U.S.A
    ASPEN
    Not Confirmed
    arrow

    10

    Alprazolam Usp

    U.S.A
    ASPEN
    Not Confirmed
    arrow
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    Excipients

    Click here to find the perfect excipient manufacturers by their capabilities

    Inspections and registrations

    Upload your audits for free, ask us

    FDA

    read-more
    read-more

    01

    FDA Audited

    USA
    ASPEN
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    ASPEN
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-09-15

    Viatris

    City : Carole Park

    State :

    Country/Area : AU

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-09-15

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    02

    FDA Audited

    USA
    ASPEN
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    ASPEN
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-08-29

    Viatris

    City : Ahmedabad

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-08-29

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    03

    FDA Audited

    USA
    ASPEN
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    ASPEN
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-07-31

    Viatris

    City : Rockford

    State : IL

    Country/Area : US

    Zip : 61103-1287

    District : CHI

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-07-31

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    04

    FDA Audited

    USA
    ASPEN
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    ASPEN
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-07-31

    Viatris

    City : Rockford

    State : IL

    Country/Area : US

    Zip : 61103-1201

    District : CHI

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-07-31

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    05

    FDA Audited

    USA
    ASPEN
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    ASPEN
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-04-07

    Viatris

    City : Parawada Mandal, Visakhap...

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-04-07

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    06

    FDA Audited

    USA
    ASPEN
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    ASPEN
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-04-04

    Viatris

    City : Anekal Taluk, Bangalore

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-04-04

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    07

    FDA Audited

    USA
    ASPEN
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    ASPEN
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-04-24

    Viatris

    City : Morgantown

    State : WV

    Country/Area : US

    Zip : 26505-2730

    District : BLT

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-04-24

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    08

    FDA Audited

    USA
    ASPEN
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    ASPEN
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-10-31

    Viatris

    City : Etobicoke

    State :

    Country/Area : CA

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-10-31

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    09

    FDA Audited

    USA
    ASPEN
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    ASPEN
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-08-08

    Viatris

    City : Bangalore,

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Postmarket Surv. and Epidemiolog...

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-08-08

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    10

    FDA Audited

    USA
    ASPEN
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    ASPEN
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-05-27

    Viatris

    City : Galway

    State :

    Country/Area : IE

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-05-27

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    Data Compilation
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    ABOUT THIS PAGE

    Contact Viatris and get a quotation

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