Lupin bags USFDA nod for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets

Mumbai: Global pharma major Lupin Limited has announced that the company 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 New Drug Application for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets.

This product would be manufactured at Lupin’s Nagpur facility in India.

Dolutegravir Lamivudine is a FDC antiretroviral medication to treat HIV/AIDS and Tenofovir alafenamide is a medication to treat chronic hepatitis B virus in adults with compensated liver disease.

Commenting on the same, Mr. Naresh Gupta, President - API and Global Institution Business, Lupin said, “At Lupin, we are unwavering in our commitment to providing affordable and quality treatment options for patients in low and middle-income countries. We are pleased to receive the U.S. FDA’ stentative approval of Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets, which significantly bolsters our HIV portfolio.”

Read also: Lupin Dolutegravir Tablets for Oral Suspension gets tentative USFDA nod for HIV/AIDS

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 7.9% of its revenue in research and development in FY23. 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.