Company profile for Viatris

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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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CONTACT DETAILS

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Country
Country
U.S.A
Address
Address
Robert J. Coury Global Center 1000 Mylan Blvd. Canonsburg, PA 15317
Telephone
Telephone
+1.724.514.1800
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INTERVIEW #SpeakPharma

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

Impressions: 4916

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

Radio Compass
16 Dec 2024

VLOG #PharmaReel

[Sponsored by another company]

DATA COMPILATION #PharmaFlow

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

Impressions: 4560

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

#PharmaFlow by PHARMACOMPASS
16 Jan 2025

NEWS #PharmaBuzz

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

PR NEWSWIRE
07 Jan 2025

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

FDA
03 Jan 2025

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

REUTERS
24 Dec 2024

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

FDA
24 Dec 2024

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

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

FDA
18 Dec 2024

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Aciclovir

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

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Aciclovir

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Febuxostat

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Febuxostat

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Irbesartan

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Irbesartan

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Itraconazole

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Itraconazole

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Lansoprazole

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Lansoprazole

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Rizatriptan Benzoate

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Rizatriptan Benzoate

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Rosuvastatin Calcium

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Rosuvastatin Calcium

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Valacyclovir Hydrochloride

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Valacyclovir Hydrochloride

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Allopurinol

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Allopurinol

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Lamivudine

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

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Lamivudine

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USDMF

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CEP/COS

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Atenolol

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Azathioprine

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Capecitabine

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Ciprofloxacin

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Dacarbazine

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Desmopressin

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Drugs in Development

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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

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Viatris

U.S.A
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Viatris

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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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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

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Viatris

U.S.A
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Viatris

U.S.A
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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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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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Viatris

U.S.A
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Viatris

U.S.A
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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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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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Viatris

U.S.A
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Viatris

U.S.A
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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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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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Viatris

U.S.A
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Viatris

U.S.A
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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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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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Viatris

U.S.A
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Viatris

U.S.A
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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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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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Viatris

U.S.A
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Viatris

U.S.A
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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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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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Viatris

U.S.A
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Viatris

U.S.A
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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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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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Viatris

U.S.A
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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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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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Viatris

U.S.A
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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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FDF Dossiers

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01

Brand Name : Idarubicin

Duphat
Not Confirmed
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Brand Name : Idarubicin

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Duphat
Not Confirmed

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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02

Brand Name : Kavideza

Duphat
Not Confirmed
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Brand Name : Kavideza

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Duphat
Not Confirmed

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

Duphat
Not Confirmed
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Brand Name : Kavimun Paed

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Duphat
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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

Duphat
Not Confirmed
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Brand Name : KAVIMUN

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Duphat
Not Confirmed

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

Duphat
Not Confirmed
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Brand Name : KAVIMUN

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Duphat
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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...

Duphat
Not Confirmed
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Brand Name : Dumiva Dispersible T...

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Duphat
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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...

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Not Confirmed
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Brand Name : MYLAN-ABACAVIR/LAMIV...

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Duphat
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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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08

Brand Name : Abacavir/Lamivudine ...

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

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Duphat
Not Confirmed

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 ...

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

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Duphat
Not Confirmed

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

Duphat
Not Confirmed
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Brand Name : ABACAVIR SULFATE

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Not Confirmed

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

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Brand Name : ABACAVIR SULFATE

Duphat
Not Confirmed
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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

Duphat
Not Confirmed
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Brand Name : ABACAVIR SULFATE

Duphat
Not Confirmed
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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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03

Brand Name : ABACAVIR SULFATE

Duphat
Not Confirmed
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Brand Name : ABACAVIR SULFATE

Duphat
Not Confirmed
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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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04

Brand Name : ABACAVIR SULFATE; LA...

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

Duphat
Not Confirmed
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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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05

Brand Name : ABACAVIR SULFATE; LA...

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

Duphat
Not Confirmed
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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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06

Brand Name : ABACAVIR SULFATE, LA...

Duphat
Not Confirmed
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Brand Name : ABACAVIR SULFATE, LA...

Duphat
Not Confirmed
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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

Duphat
Not Confirmed
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Brand Name : EPZICOM

Duphat
Not Confirmed
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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...

Duphat
Not Confirmed
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Brand Name : ABACAVIR AND LAMIVUD...

Duphat
Not Confirmed
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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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09

Brand Name : ABIRATERONE ACETATE

Duphat
Not Confirmed
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Brand Name : ABIRATERONE ACETATE

Duphat
Not Confirmed
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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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10

Brand Name : ABIRATERONE ACETATE

Duphat
Not Confirmed
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Brand Name : ABIRATERONE ACETATE

Duphat
Not Confirmed
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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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Excipients

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Inspections and registrations

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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
Not Confirmed

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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02

FDA Audited

USA
Duphat
Not Confirmed
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FDA Audited

USA
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Duphat
Not Confirmed

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

USA
Duphat
Not Confirmed
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FDA Audited

USA
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Duphat
Not Confirmed

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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04

FDA Audited

USA
Duphat
Not Confirmed
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FDA Audited

USA
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Duphat
Not Confirmed

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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05

FDA Audited

USA
Duphat
Not Confirmed
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FDA Audited

USA
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Duphat
Not Confirmed

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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06

FDA Audited

USA
Duphat
Not Confirmed
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FDA Audited

USA
arrow
Duphat
Not Confirmed

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

USA
Duphat
Not Confirmed
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FDA Audited

USA
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Duphat
Not Confirmed

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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08

FDA Audited

USA
Duphat
Not Confirmed
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FDA Audited

USA
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Duphat
Not Confirmed

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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09

FDA Audited

USA
Duphat
Not Confirmed
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FDA Audited

USA
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Duphat
Not Confirmed

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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10

FDA Audited

USA
Duphat
Not Confirmed
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FDA Audited

USA
arrow
Duphat
Not Confirmed

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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