Lupin bags tentative USFDA nod for Dolutegravir, Emtricitabine and Tenofovir Alafenamide Tablets to control HIV infections

Published On 2023-01-31 10:00 GMT   |   Update On 2023-01-31 09:59 GMT
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Mumbai: Global pharma major Lupin Limited today announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Dolutegravir, Emtricitabine and Tenofovir Alafenamide (DETAF) Tablets.

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

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DETAF would be a welcome new addition in the management of HIV infections and will be available for supplies to low- & middle-income countries, the company stated.

The human immunodeficiency virus (HIV) targets the immune system and weakens people's defense against many infections and some types of cancer that people with healthy immune systems can more easily fight off.

Commenting on the same, Naresh Gupta, President - API and Global Institution Business, Lupin said, “We are committed to providing affordable and quality treatment options to patients in low- and middle income countries. We are pleased that U.S. FDA has tentatively approved DETAF, which will significantly enhance our HIV portfolio."

Read also: Lupin bags USFDA nod for Dolutegravir, Rilpivirine tablets to treat HIV infection

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 8.7% of its revenue in research and development in FY22. Lupin has 15 manufacturing sites, 7 research centers and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.
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