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

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

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

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    16 Dec 2024
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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    FDA’s landmark approvals of BMS’ schizo med, Madrigal’s MASH drug, US$ 16.5 bn Catalent buyout make it to top 10 news of 2024

    FDA’s landmark approvals of BMS’ schizo med, Madrigal’s MASH drug, US$ 16.5 bn Catalent buyout make it to top 10 news of 2024

    The year 2024 was marked by some landmark drug approvals in the areas of schizophrenia, metabolic dysfunction-associated steatohepatitis (MASH), chronic obstructive pulmonary disease (COPD) and Alzheimer’s disease. The incoming Trump administration, monkeypox outbreak and drug price negotiations in the US also created big news. Here is PharmaCompass’ compilation of the top 10 news from Phispers of 2024. I. BMS’ US$ 14 bn Karuna bet pays off with landmark FDA approval for schizophrenia med Cobenfy The US Food and Drug Administration’s groundbreaking approval of Bristol Myers Squibb’s Cobenfy to treat schizophrenia has made it to our number one spot. BMS had acquired Cobenfy through its US$ 14 billion purchase of Karuna Therapeutics, announced in December 2023. Cobenfy is the first-ever antipsychotic that targets cholinergic receptors. Cobenfy’s new approach has experts excited. Its peak sales are expected to come in at US$ 7.5 billion a year. While BMS’ Karuna buyout paid off, AbbVie’s US$ 8.7 billion acquisition of Cerevel Therapeutics was dampened when their lead candidate and schizophrenia drug emraclidine failed to meet phase 2 endpoints in two pivotal trials. II. 2024’s biggest deal, US$ 16.5 bn Catalent buyout by Novo’s parent, cleared after intense scrutiny  On number two spot is Novo Nordisk Foundation’s acquistion of Catalent via its investment arm Novo Holdings for US$ 16.5 billion, announced in February 2024. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. Easily the biggest biopharma acquisition of last year, the deal  faced criticism from lawmakers and consumer groups for its potential anti-competitive effects, particularly in the glucagon-like peptide-1 (GLP-1) drug market. Its main competitor Eli Lilly called for scrutiny by competition regulators. However, in December, both the EU regulator and the US Federal Trade Commission gave it the greenlight. III. Madrigal’s Rezdiffra becomes first FDA-approved drug for liver disease MASH For quite some time, the drug development field for the liver condition MASH had been a graveyard for failed programs. In 2024, the field celebrated a hurrah moment when Madrigal’s oral drug Rezdiffra became the first treatment in the US for adults with this common fatty liver disease. The approval has opened a multi-billion dollar opportunity for Madrigal with the American Liver Foundation CEO Lorraine Stiehl calling it a “game-changing” moment. IV. COPD patients get two new treatments — Verona’s Ohtuvayre and Sanofi-Regeneron’s Dupixent The COPD landscape saw remarkable advances in 2024. FDA approved Verona Pharma’s Ohtuvayre, which brings the first new mechanism of action in over two decades for the treatment of COPD. This dual-action, inhaled medication serves as both a bronchodilator and an anti-inflammatory agent, offering a comprehensive approach to symptom management. Adding to this progress, Sanofi and Regeneron’s Dupixent achieved a historic milestone by becoming the first biologic approved for treating COPD. Over 390 million people are living with COPD worldwide. V. Novartis inks 20 deals in 2024, promises over US$ 25 billion in biobucks, lays bets on radiopharmas Novartis has been investing in early-stage science, buying out companies in the sub-US$ 5 billion range. The Swiss drugmaker Novartis inked over 20 deals in 2024, paying over US$ 5.5 billion upfront and promising over US$ 25 billion in biobucks. The company has particularly focused on radiopharmaceuticals and molecular glue degraders. It acquired Mariana Oncology to strengthen its radioligand therapy (RLT) pipeline, and also inked RLT deals with PeptiDream and Ratio Therapeutics. VI. Despite political pressure, FDA rejects first MDMA-assisted therapy to treat PTSD; Lykos faces expanded probe In August, FDA declined to approve an MDMA-assisted therapy from Lykos Therapeutics to treat post-traumatic stress disorder (PTSD). In the lead-up to the FDA decision, 80 members of Congress from both sides of the aisle had urged US President Joe Biden and the FDA to consider further studies on the therapy. Not satisfied with just declining Lykos’ MDMA-assisted therapy for PTSD, FDA had expanded its investigation into the clinical trials that tested it. Lykos CEO Amy Emerson stepped down after reducing its workforce by 75 percent. Additionally, its founder Rick Doblin exited its board. VII. Alzheimer’s gets two new treatments as FDA approves Lilly’s Kisunla, Alpha Cognition’s Zunveyl FDA finally approved Eli Lilly’s Alzheimer’s drug Kisunla in July, after delaying action on it in March. This approval, along with that of Biogen and Eisai’s Leqembi in 2023, mark successes in treating the mind-wasting disease after three decades of failed efforts. FDA also approved Alpha Cognition’s Zunveyl to treat mild-to-moderate Alzheimer’s disease. Zunveyl is a prodrug of Alzheimer’s medication galantamine, and is to be taken orally twice a day. Alpha said Zunveyl is designed to address the tolerability issues with galantamine. VIII. IRA price talks conclude; Stelara, Enbrel, Eliquis to bring 51.4% of Medicare savings After filing futile lawsuits questioning the constitutional validity of the Medicare drug price negotiations under the Inflation Reduction Act (IRA), all drug companies came to the bargaining table. In August, the Biden-Harris Administration announced it had reached agreements for lower prices for all 10 drugs selected for negotiations under the IRA. The new prices come into effect from January 1, 2026. A Brookings Institution report said that just three drugs will account for over half of the expected US$ 6 billion savings in 2026. J&J’s Stelara (US$ 1.4 billion), Amgen’s Enbrel (US$ 1.1 billion), and BMS’ Eliquis (US$ 856 million) are expected to account for US$ 3.28 billion or 51.4 percent of Medicare savings. IX. Trump’s picks for new administration send shockwaves across markets, stocks of vaccine makers tumble  Donald Trump’s picks for his new administration not only created big news, but also impacted the stock markets. His selection of Robert F. Kennedy Jr., an anti-vaccine activist, to lead the Department of Health and Human Services (HHS), sent shares of several vaccine manufacturers plummeting. In the US, stocks of Pfizer, Moderna, and Novavax dipped. In Europe, stocks of BioNTech, GSK, and Bavarian Nordic tumbled. Trump has nominated Mehmet Oz, a celebrity TV host, to run the Centers for Medicare and Medicaid Services (CMS), which oversees health insurance. X. New mpox outbreak in Africa sparks global response; FDA approves Emergent’s vaccine to treat mpox In August, a new mpox virus clade put Africa in the throes of an mpox outbreak. The WHO declared it a public health emergency of international concern. Emergent BioSolutions said it will donate 50,000 doses of its smallpox vaccine ACAM2000. Multiple countries responded with donations of Bavarian Nordic’s Jynneos, the only widely-approved mpox vaccine at the time. In early September, the FDA approved Emergent’s ACAM2000 as the second mpox vaccine.
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    Impressions: 1799

    https://www.pharmacompass.com/radio-compass-blog/fda-s-landmark-approvals-of-bms-schizo-med-madrigal-s-mash-drug-us-16-5-bn-catalent-buyout-make-it-to-top-10-news-of-2024

    #Phispers by PHARMACOMPASS
    02 Jan 2025
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    NEWS #PharmaBuzz

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    Viatris to Present at 43rd Annual J.P. Morgan Conference
    Viatris to Present at 43rd Annual J.P. Morgan Conference

    07 Jan 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/viatris-to-present-at-the-43rd-annual-jp-morgan-healthcare-conference-302343481.html

    PR NEWSWIRE
    07 Jan 2025
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    FDA Issues Form 483 to Mylan Laboratories Ltd
    FDA Issues Form 483 to Mylan Laboratories Ltd

    03 Jan 2025

    // FDA

    https://www.fda.gov/media/184861/download

    FDA
    03 Jan 2025
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    FDA restricts imports of some Viatris drugs made at India facility
    FDA restricts imports of some Viatris drugs made at India facility

    24 Dec 2024

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-sends-warning-letter-viatris-over-india-manufacturing-facility-2024-12-23/

    REUTERS
    24 Dec 2024
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    Viatris Receives FDA Warning Letter
    Viatris Receives FDA Warning Letter

    24 Dec 2024

    // FDA

    https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/viatris-inc-690897-12192024

    FDA
    24 Dec 2024
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    Viatris Publishes Phase 2b CARE Study Data for Cenerimod
    Viatris Publishes Phase 2b CARE Study Data for Cenerimod

    18 Dec 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/viatris-announces-publication-of-phase-2b-care-study-data-for-cenerimod-in-lancet-rheumatology-302334364.html

    PR NEWSWIRE
    18 Dec 2024
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    Enforcement Report - Week of December 18, 2024
    Enforcement Report - Week of December 18, 2024

    18 Dec 2024

    // FDA

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-december-18-2024-87175.pdf

    FDA
    18 Dec 2024
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    ALL APIs

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    01

    Aciclovir

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

    Duphat
    Not Confirmed
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    Aciclovir

    U.S.A

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

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    Duphat
    Not Confirmed
    • fda
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    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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    02

    Febuxostat

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

    Duphat
    Not Confirmed
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    Febuxostat

    U.S.A

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

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    Duphat
    Not Confirmed
    • fda
    • EDQM
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    ✖

    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

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    03

    Irbesartan

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

    Duphat
    Not Confirmed
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    Irbesartan

    U.S.A

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

    arrow
    Duphat
    Not Confirmed
    • fda
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    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 :

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    04

    Itraconazole

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

    Duphat
    Not Confirmed
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    Itraconazole

    U.S.A

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

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    Duphat
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    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

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    05

    Lansoprazole

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

    Duphat
    Not Confirmed
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    Lansoprazole

    U.S.A

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

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    Duphat
    Not Confirmed
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    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
    ✖

    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

    Duphat
    Not Confirmed
    arrow

    Rizatriptan Benzoate

    U.S.A

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 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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    Market
    Place

    07

    Rosuvastatin Calcium

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

    Duphat
    Not Confirmed
    arrow

    Rosuvastatin Calcium

    U.S.A

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-02-07

    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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    Market
    Place

    08

    Valacyclovir Hydrochloride

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

    Duphat
    Not Confirmed
    arrow

    Valacyclovir Hydrochloride

    U.S.A

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 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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    Market
    Place

    09

    Allopurinol

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

    Duphat
    Not Confirmed
    arrow

    Allopurinol

    U.S.A

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 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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    Market
    Place

    10

    Lamivudine

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

    Duphat
    Not Confirmed
    arrow

    Lamivudine

    U.S.A

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-08-28

    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
    Duphat
    Not Confirmed
    arrow

    02

    Abacavir Sulfate Usp

    U.S.A
    Duphat
    Not Confirmed
    arrow

    03

    Abaloparatide

    U.S.A
    Duphat
    Not Confirmed
    arrow

    04

    Abametapir

    U.S.A
    Duphat
    Not Confirmed
    arrow

    05

    Acyclovir Usp

    U.S.A
    Duphat
    Not Confirmed
    arrow

    06

    Adefovir Dipivoxil

    U.S.A
    Duphat
    Not Confirmed
    arrow

    07

    Alendronate Sodium Usp (trihydrate)

    U.S.A
    Duphat
    Not Confirmed
    arrow

    08

    Allopurinol Usp

    U.S.A
    Duphat
    Not Confirmed
    arrow

    09

    Almotriptan Malate Usp

    U.S.A
    Duphat
    Not Confirmed
    arrow

    10

    Alprazolam Usp

    U.S.A
    Duphat
    Not Confirmed
    arrow
    Only 10 entries up to this point, click to access all click full view read-more
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    CEP/COS

    read-more
    read-more

    01

    Amlodipine besilate

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    02

    Amlodipine besilate, Process C

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    03

    Atenolol

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    04

    Azathioprine

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    05

    Capecitabine

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    06

    Ciprofloxacin

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    07

    Ciprofloxacin Hydrochloride

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    08

    Clopidogrel hydrogen sulfate

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    09

    Dacarbazine

    CEP/COS

    Duphat
    Not Confirmed
    arrow

    10

    Desmopressin

    CEP/COS

    Duphat
    Not Confirmed
    arrow
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    Drugs in Development

    read-more
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    Viatris Licenses Sotagliflozin from Lexicon Outside U.S. and Europe

    Details:

    Under the license agreement, Viatris will acquire the rights to Inpefa (sotagliflozin) from Lexicon for the treatment of heart failure and type 2 diabetes in all markets outside the U.S. and Europe.


    Lead Product(s): Sotagliflozin

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Inpefa

    Study Phase: ApprovedProduct Type: Small molecule

    Recipient: Lexicon pharmaceuticals

    Deal Size: Undisclosed Upfront Cash: $25.0 million

    Deal Type: Licensing Agreement October 16, 2024

    blank

    01

    Viatris

    U.S.A
    arrow
    Duphat
    Not Confirmed

    Viatris

    U.S.A
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    Duphat
    Not Confirmed
    • fda
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    Lead Product(s) : Sotagliflozin

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved

    Recipient : Lexicon pharmaceuticals

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Viatris Licenses Sotagliflozin from Lexicon Outside U.S. and Europe

    Details : Under the license agreement, Viatris will acquire the rights to Inpefa (sotagliflozin) from Lexicon for the treatment of heart failure and type 2 diabetes in all markets outside the U.S. and Europe.

    Brand Name : Inpefa

    Molecule Type : Small molecule

    Upfront Cash : $25.0 million

    October 16, 2024

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    Viatris Announces Positive Results from EFFEXOR Study in GAD Patients

    Details:

    Effexor (Venlafaxine HCl) is a serotonin and norepinephrine reuptake inhibitor. It is indicated for the treatment of Generalized Anxiety Disorder.


    Lead Product(s): Venlafaxine Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: Effexor

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 09, 2024

    blank

    02

    Viatris

    U.S.A
    arrow
    Duphat
    Not Confirmed

    Viatris

    U.S.A
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    Duphat
    Not Confirmed
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    Lead Product(s) : Venlafaxine Hydrochloride

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Viatris Announces Positive Results from EFFEXOR Study in GAD Patients

    Details : Effexor (Venlafaxine HCl) is a serotonin and norepinephrine reuptake inhibitor. It is indicated for the treatment of Generalized Anxiety Disorder.

    Brand Name : Effexor

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    October 09, 2024

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    Gilead Partners with Six Generics For Lenacapavir Access in HIV Prevention

    Details:

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


    Lead Product(s): Lenacapavir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Sunlenca

    Study Phase: Phase IIIProduct Type: Small molecule

    Recipient: Gilead Sciences

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement October 02, 2024

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    03

    Viatris

    U.S.A
    arrow
    Duphat
    Not Confirmed

    Viatris

    U.S.A
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    Duphat
    Not Confirmed
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    Lead Product(s) : Lenacapavir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase III

    Recipient : Gilead Sciences

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Gilead Partners with Six Generics For Lenacapavir Access in HIV Prevention

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

    Brand Name : Sunlenca

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    October 02, 2024

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    Calliditas’ Partner Viatris Pharma Starts Phase III Trial with Nefecon in Japan

    Details:

    Nefecon is an oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity, indicated for IgA nephropathy.


    Lead Product(s): Budesonide

    Therapeutic Area: Nephrology Brand Name: Nefecon

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 05, 2024

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    04

    Viatris

    U.S.A
    arrow
    Duphat
    Not Confirmed

    Viatris

    U.S.A
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    Duphat
    Not Confirmed
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    Lead Product(s) : Budesonide

    Therapeutic Area : Nephrology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Calliditas’ Partner Viatris Pharma Starts Phase III Trial with Nefecon in Japan

    Details : Nefecon is an oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity, indicated for IgA nephropathy.

    Brand Name : Nefecon

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 05, 2024

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    Viatris Launches RYZUMVl™ (Phentolamine Ophthalmic Solution) 0.75% in The U.S.

    Details:

    Ryzumvi (phentolamine mesylate) is an alpha adrenergic blocker indicated for treating pharmacologically-induced mydriasis produced by adrenergic agonists or parasympatholytic agents like tropicamide.


    Lead Product(s): Phentolamine Mesylate

    Therapeutic Area: Ophthalmology Brand Name: Ryzumvi

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 01, 2024

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    05

    Viatris

    U.S.A
    arrow
    Duphat
    Not Confirmed

    Viatris

    U.S.A
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    Duphat
    Not Confirmed
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    Lead Product(s) : Phentolamine Mesylate

    Therapeutic Area : Ophthalmology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Viatris Launches RYZUMVl™ (Phentolamine Ophthalmic Solution) 0.75% in The U.S.

    Details : Ryzumvi (phentolamine mesylate) is an alpha adrenergic blocker indicated for treating pharmacologically-induced mydriasis produced by adrenergic agonists or parasympatholytic agents like tropicamide.

    Brand Name : Ryzumvi

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    April 01, 2024

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    Idorsia and Viatris Close Global Research Collaboration Transaction

    Details:

    The collaboration focuses on the clinical development & commercialization of ACT-246475 (selatogrel), a reversible, highly selective P2Y12 inhibitor for treating Acute Myocardial Infarction.


    Lead Product(s): Selatogrel

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: ACT-246475

    Study Phase: Phase IIIProduct Type: Small molecule

    Recipient: Idorsia Pharmaceuticals

    Deal Size: Undisclosed Upfront Cash: $350.0 million

    Deal Type: Collaboration March 18, 2024

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    06

    Viatris

    U.S.A
    arrow
    Duphat
    Not Confirmed

    Viatris

    U.S.A
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    Duphat
    Not Confirmed
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    Lead Product(s) : Selatogrel

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase III

    Recipient : Idorsia Pharmaceuticals

    Deal Size : Undisclosed

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Idorsia and Viatris Close Global Research Collaboration Transaction

    Details : The collaboration focuses on the clinical development & commercialization of ACT-246475 (selatogrel), a reversible, highly selective P2Y12 inhibitor for treating Acute Myocardial Infarction.

    Brand Name : ACT-246475

    Molecule Type : Small molecule

    Upfront Cash : $350.0 million

    March 18, 2024

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    Idorsia and Viatris Enter Into a Significant Global Research and Development Collaboration

    Details:

    The collaboration focuses on the clinical development and commercialization of ACT-246475 (selatogrel), a fast-acting, selective P2Y12 inhibitor for treating Acute Myocardial Infarction.


    Lead Product(s): Selatogrel

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: ACT-246475

    Study Phase: Phase IIIProduct Type: Small molecule

    Recipient: Idorsia Pharmaceuticals

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration February 27, 2024

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    07

    Viatris

    U.S.A
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    Duphat
    Not Confirmed

    Viatris

    U.S.A
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    Lead Product(s) : Selatogrel

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase III

    Recipient : Idorsia Pharmaceuticals

    Deal Size : Undisclosed

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Idorsia and Viatris Enter Into a Significant Global Research and Development Collaboration

    Details : The collaboration focuses on the clinical development and commercialization of ACT-246475 (selatogrel), a fast-acting, selective P2Y12 inhibitor for treating Acute Myocardial Infarction.

    Brand Name : ACT-246475

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    February 27, 2024

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    Viatris and Theravance Biopharma Announce Positive Top-Line Results from YUPELRI® (revefenacin) Phase III Trial in China for the Treatment of Chronic O...

    Details:

    YUPELRI® (revefenacin) inhalation solution is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease.


    Lead Product(s): Revefenacin

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Yupelri

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 13, 2023

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    08

    Viatris

    U.S.A
    arrow
    Duphat
    Not Confirmed

    Viatris

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Revefenacin

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

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    Viatris and Theravance Biopharma Announce Positive Top-Line Results from YUPELRI® (revefenacin) P...

    Details : YUPELRI® (revefenacin) inhalation solution is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease.

    Brand Name : Yupelri

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    November 13, 2023

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    Theramex Announces Agreement to Acquire the European Rights to Duphaston® and Femoston® from Viatris, Inc.

    Details:

    Through the agreement, Viatris divests its rights to women's healthcare products Duphaston (dydrogesterone) and Femoston (estradiol/dydrogesterone) to Theramex.


    Lead Product(s): Dydrogesterone

    Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Duphaston

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Theramex

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Divestment October 10, 2023

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    Viatris

    U.S.A
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    Lead Product(s) : Dydrogesterone

    Therapeutic Area : Obstetrics/Gynecology (Women’s Health)

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Theramex

    Deal Size : Undisclosed

    Deal Type : Divestment

    DEALS_DEV arrow-down

    Theramex Announces Agreement to Acquire the European Rights to Duphaston® and Femoston® from Via...

    Details : Through the agreement, Viatris divests its rights to women's healthcare products Duphaston (dydrogesterone) and Femoston (estradiol/dydrogesterone) to Theramex.

    Brand Name : Duphaston

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    October 10, 2023

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    Viatris Announces Agreements on Remaining Planned Divestitures; Upon Closing Would Achieve its Original Total Target of a Multiple Above 12x on 2022 Est...

    Details:

    Through the agreement, Viatris divests its rights to women's healthcare products Duphaston (dydrogesterone) and Femoston (sstradiol/dydrogesterone) to Theramex and its Women's Healthcare business, primarily related to oral and injectable contraceptives, to Insud Pharma.


    Lead Product(s): Dydrogesterone

    Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Duphaston

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Theramex

    Deal Size: $3,370.0 million Upfront Cash: Undisclosed

    Deal Type: Divestment October 01, 2023

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    Viatris

    U.S.A
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    Lead Product(s) : Dydrogesterone

    Therapeutic Area : Obstetrics/Gynecology (Women’s Health)

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Theramex

    Deal Size : $3,370.0 million

    Deal Type : Divestment

    DEALS_DEV arrow-down

    Viatris Announces Agreements on Remaining Planned Divestitures; Upon Closing Would Achieve its Ori...

    Details : Through the agreement, Viatris divests its rights to women's healthcare products Duphaston (dydrogesterone) and Femoston (sstradiol/dydrogesterone) to Theramex and its Women's Healthcare business, primarily related to oral and injectable contraceptives, ...

    Brand Name : Duphaston

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    October 01, 2023

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    01

    Brand Name : Idarubicin

    U.S.A
    Duphat
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    Brand Name : Idarubicin

    U.S.A
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    Regulatory Info :

    Registration Country : Italy

    4-Demethoxydaunomycin

    Viatris

    Dosage Form : Idarubicin 10Mg 10Ml 1 U...

    Brand Name : Idarubicin

    Dosage Strength : 1 vial EV 10 mg/10 ml

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Brand Name : Kavideza

    U.S.A
    Duphat
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    Brand Name : Kavideza

    U.S.A
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir

    Viatris

    Dosage Form : FCT

    Brand Name : Kavideza

    Dosage Strength : 600mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    03

    Brand Name : Kavimun Paed

    U.S.A
    Duphat
    Not Confirmed
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    Brand Name : Kavimun Paed

    U.S.A
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    Regulatory Info : Originator

    Registration Country : South Africa

    Abacavir

    Viatris

    Dosage Form : TAB

    Brand Name : Kavimun Paed

    Dosage Strength : 60mg

    Packaging : 60X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    04

    Brand Name : KAVIMUN

    U.S.A
    Duphat
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    Brand Name : KAVIMUN

    U.S.A
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir

    Viatris

    Dosage Form : FCT

    Brand Name : KAVIMUN

    Dosage Strength : 300mg

    Packaging : 60X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    05

    Brand Name : KAVIMUN

    U.S.A
    Duphat
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    Brand Name : KAVIMUN

    U.S.A
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir

    Viatris

    Dosage Form : FCT

    Brand Name : KAVIMUN

    Dosage Strength : 300mg

    Packaging : 56X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    06

    Brand Name : Dumiva Dispersible T...

    U.S.A
    Duphat
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    Brand Name : Dumiva Dispersible T...

    U.S.A
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir

    Viatris

    Dosage Form : DSP

    Brand Name : Dumiva Dispersible Tablet...

    Dosage Strength : 120mg

    Packaging : 60X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    07

    Brand Name : MYLAN-ABACAVIR/LAMIV...

    U.S.A
    Duphat
    Not Confirmed
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    Brand Name : MYLAN-ABACAVIR/LAMIV...

    U.S.A
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    Regulatory Info :

    Registration Country : Canada

    ABACAVIR (ABACAVIR SULFATE)

    Viatris

    Dosage Form : TABLET

    Brand Name : MYLAN-ABACAVIR/LAMIVUDINE

    Dosage Strength : 600MG

    Packaging : 30

    Approval Date :

    Application Number : 2450682

    Regulatory Info :

    Registration Country : Canada

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    Brand Name : Abacavir/Lamivudine ...

    Australia
    Duphat
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    Brand Name : Abacavir/Lamivudine ...

    Australia
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    Regulatory Info :

    Registration Country : Australia

    Abacavir + Lamivudine

    Alphapharm PTY Ltd

    Dosage Form : Film-coated Tablet; Film...

    Brand Name : Abacavir/Lamivudine Mylan

    Dosage Strength : 600MG; 300MG

    Packaging : 30

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    09

    Brand Name : Abacavir/Lamivudine ...

    Australia
    Duphat
    Not Confirmed
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    Brand Name : Abacavir/Lamivudine ...

    Australia
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    Regulatory Info :

    Registration Country : Australia

    Abacavir + Lamivudine

    Alphapharm PTY Ltd

    Dosage Form : Film-coated Tablet; Film...

    Brand Name : Abacavir/Lamivudine Viatr...

    Dosage Strength : 600MG; 300MG

    Packaging : 30

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    10

    Brand Name : ABACAVIR SULFATE

    U.S.A
    Duphat
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    ABACAVIR SULFATE

    Viatris

    Dosage Form : TABLET;ORAL

    Brand Name : ABACAVIR SULFATE

    Dosage Strength : EQ 300MG BASE

    Packaging :

    Approval Date : 2012-06-18

    Application Number : 91294

    Regulatory Info : RX

    Registration Country : USA

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    FDA Orange Book

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    01

    Brand Name : ABACAVIR SULFATE

    China
    Duphat
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    Brand Name : ABACAVIR SULFATE

    China
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    RLD :

    TE Code :

    ABACAVIR SULFATE

    MATRIX LABORATORIES XIAMEN LTD.

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE

    Dosage Strength : 300MG

    Approval Date :

    Application Number : 78742

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    02

    Brand Name : ABACAVIR SULFATE

    U.S.A
    Duphat
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE

    U.S.A
    Duphat
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    RLD : No

    TE Code : AB

    ABACAVIR SULFATE

    Viatris

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE

    Dosage Strength : EQ 300MG BASE

    Approval Date : 2012-06-18

    Application Number : 91294

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Brand Name : ABACAVIR SULFATE

    U.S.A
    Duphat
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    Brand Name : ABACAVIR SULFATE

    U.S.A
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    RLD :

    TE Code :

    ABACAVIR SULFATE

    Viatris

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE

    Dosage Strength : 60 MG

    Approval Date :

    Application Number : 200733

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    Brand Name : ABACAVIR SULFATE; LA...

    U.S.A
    Duphat
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE; LA...

    U.S.A
    Duphat
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    RLD :

    TE Code :

    ABACAVIR SULFATE; LAMIVUDINE

    Viatris

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE; LAMIVU...

    Dosage Strength : 600MG; 300MG

    Approval Date :

    Application Number : 90519

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    Brand Name : ABACAVIR SULFATE; LA...

    U.S.A
    Duphat
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE; LA...

    U.S.A
    Duphat
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    RLD :

    TE Code :

    ABACAVIR SULFATE; LAMIVUDINE

    Viatris

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE; LAMIVU...

    Dosage Strength : 60MG; 30MG

    Approval Date :

    Application Number : 202381

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    Brand Name : ABACAVIR SULFATE, LA...

    U.S.A
    Duphat
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE, LA...

    U.S.A
    Duphat
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    RLD :

    TE Code :

    ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

    Viatris

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE, LAMIVU...

    Dosage Strength : EQ 300MG BASE; 150MG; 30...

    Approval Date :

    Application Number : 90309

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    07

    Brand Name : EPZICOM

    U.S.A
    Duphat
    Not Confirmed
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    Brand Name : EPZICOM

    U.S.A
    Duphat
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    RLD :

    TE Code :

    ABACAVIR; LAMIVUDINE

    Viatris

    Dosage Form : TABLET; ORAL

    Proprietary Name : EPZICOM

    Dosage Strength : 600MG;300MG

    Approval Date :

    Application Number : 204004

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    08

    Brand Name : ABACAVIR AND LAMIVUD...

    U.S.A
    Duphat
    Not Confirmed
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    Brand Name : ABACAVIR AND LAMIVUD...

    U.S.A
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    RLD :

    TE Code :

    ABACAVIR; LAMIVUDINE

    Viatris

    Dosage Form : TABLET; ORAL SUSPENSION

    Proprietary Name : ABACAVIR AND LAMIVUDINE

    Dosage Strength : 120MG;60MG

    Approval Date :

    Application Number : 204915

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    Brand Name : ABIRATERONE ACETATE

    U.S.A
    Duphat
    Not Confirmed
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    Brand Name : ABIRATERONE ACETATE

    U.S.A
    Duphat
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    RLD : No

    TE Code : AB

    ABIRATERONE ACETATE

    Viatris

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABIRATERONE ACETATE

    Dosage Strength : 250MG

    Approval Date : 2018-10-31

    Application Number : 208446

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Brand Name : ABIRATERONE ACETATE

    U.S.A
    Duphat
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    Brand Name : ABIRATERONE ACETATE

    U.S.A
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    RLD : No

    TE Code : AB

    ABIRATERONE ACETATE

    Viatris

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABIRATERONE ACETATE

    Dosage Strength : 500MG

    Approval Date : 2020-12-14

    Application Number : 208446

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    FDA

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    01

    FDA Audited

    USA
    Duphat
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    FDA Audited

    USA
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    Duphat
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    District Decision : No Action Indicated

    Inspection End Date : 2014-04-16

    Viatris

    City : Greensboro

    State : NC

    Country/Area : US

    Zip : 27406-4600

    District : ATL

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-04-16

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    FDA Audited

    USA
    Duphat
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    FDA Audited

    USA
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    Duphat
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    District Decision : No Action Indicated

    Inspection End Date : 2009-07-30

    Viatris

    City : Morgantown

    State : WV

    Country/Area : US

    Zip : 26505-2730

    District : BLT

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2009-07-30

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    03

    FDA Audited

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    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-02-17

    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 : 2010-02-17

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    District Decision : No Action Indicated

    Inspection End Date : 2010-12-09

    Viatris

    City : Morgantown

    State : WV

    Country/Area : US

    Zip : 26505-2730

    District : BLT

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2010-12-09

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    FDA Audited

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    FDA Audited

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    Duphat
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2011-07-28

    Viatris

    City : Morgantown

    State : WV

    Country/Area : US

    Zip : 26505-2730

    District : BLT

    Center : CDER

    Project Area : Postmarket Surv. and Epidemiolog...

    District Decision : No Action Indicated

    Inspection End Date : 2011-07-28

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    FDA Audited

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    FDA Audited

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    Duphat
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-02-02

    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 : 2012-02-02

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    07

    FDA Audited

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    FDA Audited

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    Duphat
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-03-21

    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 : 2014-03-21

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    FDA Audited

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    FDA Audited

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    Duphat
    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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    FDA Audited

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    District Decision : No Action Indicated

    Inspection End Date : 2012-03-13

    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 : 2012-03-13

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    FDA Audited

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    District Decision : No Action Indicated

    Inspection End Date : 2012-03-13

    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 : 2012-03-13

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    ABOUT THIS PAGE

    Contact Agila Specialties Private Limited and get a quotation

    Agila Specialties Private Limited is a supplier offers 391 products (APIs, Excipients or Intermediates).

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