Lupin receives tentative approval from US-FDA for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets under US-PEPFAR; Product to be manufactured at Nagpur facility

Pharmaceutical tablets and capsules are arranged on table in photo illustration
Pharmaceutical tablets and capsules. Meel Bijendra/Agrika/illustration

MUMBAI, July 21 (MeelBijendra) – On Friday, Lupin Limited an Indian multinational pharmaceutical company based in Mumbai announced that it has received tentative approval from the United States Food and Drug Administration (US FDA) under the US President’s Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Dolutegravir Lamivudine and Tenofovir Alafenamide tablets.

As per IQVIA MAT Sep-22, Lupin is ranked 6th in India’s pharma market by sales and the 3rd largest in the US by prescription. Lupin is the market leader in 28 of the 77 products marketed in the US generic market, of which it is among the top 3 by market share in 57 products. In March 2019, the US FDA put several Lupin drug plants on notice for quality problems and indicated it might not approve future Lupin drug applications.

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Lupin’s key focus areas include diabetology, cardiovascular, pediatrics, anti-infectives, asthma and anti-tuberculosis. On the other hand, the company enjoys leadership positions 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 segments.

The company’s Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets will be manufactured in India at Lupin’s Nagpur facility – Nagpur is the third largest city in the Indian state of Maharashtra. Currently, Lupin has 15 manufacturing sites and 7 research centers.

According to economists, the Indian pharmaceutical market is a $22 billion market, with a historic growth of 11% CAGR expected to reach $30 billion by 2025 and $70 billion by 2030.

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