Lupin Limited Receives US FDA Approval for Dapagliflozin and Metformin Extended-Release Tablets
Global pharmaceutical major Lupin Limited announced on April 8, 2026, that it obtained approval from the United States Food and Drug Administration (U.S. FDA). The approval pertains to its Abbreviated New Drug Application for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets.The U.S. FDA approved Lupin's Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets as bioequivalent to Xigduo® XR for the specified indications. The approved tablet strengths include 5 mg/500 mg, 5 mg/1,000 mg, and 10 mg/500 mg, 10 mg/1,000 mg. Furthermore, the company received tentative approval for the 2.5 mg/1,000 mg combination tablet.
Lupin Limited, headquartered in Mumbai, India, is a global pharmaceutical leader that distributes products in over 100 markets. The company specializes in pharmaceutical products, encompassing branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin maintains a strong presence in the U.S. and India across several therapy areas, including cardiovascular, anti-diabetic, respiratory, gastrointestinal, anti-infective, central nervous system, and women's health.
The company operates with 15 state-of-the-art manufacturing sites and 7 research centers worldwide, supported by a workforce exceeding 24,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries: Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
LUPIN Stock Price Movement
Today, Lupin Limited shares slipped by 0.14% to settle at ₹2294.1. The stock closed the session amid noticeable trading volume totaling 1.85 million.Source:
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