Lupin receives approval from USFDA for Emtricitabine and Tenofovir Alafenamide Tablets

Lupin is an innovation-led 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.

Global pharma major Lupin Limited announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) under the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application for Emtricitabine and Tenofovir Alafenamide Tablets, 200 mg/25 mg, to market a generic equivalent of Descovy® Tablets, 200 mg/25 mg, of Gilead Sciences, Inc.  

This product will be manufactured at Lupin’s Nagpur facility in India and will be supplied to lowand middle-income countries. Emtricitabine and Tenofovir Alafenamide Tablets are indicated to treat or prevent HIV-1 infection in adults and children who weigh atleast 35 kg.  

Mr. Naresh Gupta, President – API and Global Institution Business, Lupin said, “Lupin is committed to offering affordable, quality treatments for patients. The tentative approval from the U.S. FDA for our Emtricitabine and Tenofovir Alafenamide Tablets significantly enhances our HIV medicine offering.”