Lupin Hepatitis B virus drug gets USFDA okay

Published On 2023-04-01 05:53 GMT   |   Update On 2023-04-01 05:53 GMT
Advertisement

Mumbai: Global pharma major Lupin Limited has announced that the company has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Tenofovir Alafenamide Tablets, 25 mg.

The product is a generic equivalent of Vemlidy Tablets, 25 mg, of Gilead Sciences, Inc.

Tenofovir alafenamide is indicated for the treatment of chronic hepatitis B virus infection in patients with compensated liver disease.

Advertisement

This product will be manufactured at Lupin’s Nagpur facility in India. Tenofovir Alafenamide Tablets, 25 mg, (RLD Vemlidy) had estimated annual sales of USD 531 million in the U.S. (IQVIA MAT December 2022).

Read also: USFDA okays Lupin Valbenazine Capsules to treat Dyskinesia

Lupin is a transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 8.7% of its revenue in research and development in FY22. Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

Read also: Lupin successfully completes UK MHRA inspection at Pithampur facilities



Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News