Lupin bags tentative USFDA nod for HIV-1 infection drugs
Mumbai: Global pharma major Lupin Limited today 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 low and middle-income countries.
Emtricitabine and Tenofovir Alafenamide Tablets are indicated to treat or prevent HIV-1 infection in adults and children who weigh at least 35 kg.
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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.”
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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.
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 7.8% of its revenue in research and development in FY24.
Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally,
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