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(05 Feb 2025, 12:57)

Lupin gains on receiving tentative USFDA nod for HIV drug

Lupin gained 3.66% to Rs 2,188 after the company announced that it has received a tentative approval from the U.S. Food and Drug Administration (USFDA) for its ANDA for Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide tablets.


The approved Abbreviated New Drug Application (ANDA) is the first protease inhibitor (PI)-based single-tablet regimen (STR) available for the treatment of adults and adolescents (aged ≥ 12 years) with HIV-1 infection.

The company stated that it is the exclusive first-to-file for this product. This product will be manufactured at the company’s Nagpur facility in India.

Mumbai-based Lupin is an innovation-led transnational pharmaceutical company. It 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's consolidated net profit jumped 74.1% to Rs 852.63 crore on an 11.3% increase in sales to Rs 5,497.01 crore in Q2 FY25 over Q2 FY24.

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