Mumbai, Naples, April 8, 2026: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, 10 mg/1,000 mg. The company also received tentative approval for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, 2.5 mg/1,000 mg.
The U.S. FDA has approved Lupin’s Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets as bioequivalent to Xigduo® XR for the indications in the approved labeling.
About Lupin 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. Trusted by healthcare professionals and consumers globally, 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, along with a dedicated workforce of over 24,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries - Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin
For further information or queries, please contact
Rajalakshmi Azariah Vice President & Global Head – Corporate Communications, Lupin rajalakshmiazariah@lupin.com
Elise Titan Director – U.S. Communications, Lupin
*Safe Harbor Statement
Xigduo® XR is a registered trademark of AstraZeneca AB
