Lupin wins USFDA okay for HIV-1 drug Raltegravir

Raltegravir Tablets USP, 600 mg (RLD Isentress HD) had an estimated annual sale of USD 34 million in the U.S. (IQVIA MAT March 2025). 

Mdical Dialogues team had earlier reported that the company had received approval from the USFDA for its ANDA for Emtricitabine and Tenofovir Alafenamide Tablets, 200 mg/25 mg. The approval granted for marketing of a generic equivalent of Descovy Tablets, 200 mg/25 mg of Gilead Sciences, Inc.

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Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally.

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