Mumbai, Naples, February 3, 2025: Lupin Limited (Lupin), a leading global pharmaceutical company, announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide Tablets (800 mg/150 mg/200 mg/10 mg). The formulation has been found bioequivalent to the reference listed drug (RLD), Symtuza® Tablets (800 mg/150 mg/200 mg/10 mg), developed by Janssen Products, LP. Lupin is the exclusive first-to-file applicant for this product, which will be produced at the company’s Nagpur facility in India.
About Lupin
Lupin Limited, headquartered in Mumbai, India, is a global leader in the pharmaceutical industry with a presence across over 100 international markets. The company specializes in branded and generic formulations, complex generics, biosimilars, and active pharmaceutical ingredients. With a robust presence in India and the U.S., Lupin focuses on multiple therapeutic categories, including respiratory, cardiovascular, anti-diabetic, CNS, gastrointestinal, anti-infective, and women’s health. Backed by 15 advanced manufacturing plants, 7 global R&D centers, and a workforce exceeding 22,000, Lupin is dedicated to enhancing patient outcomes worldwide. Through its verticals—Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions—the company continues to drive innovation in healthcare. Visit www.lupin.com or follow Lupin on LinkedIn for more information.
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