Lupin Receives U.S. FDA Approval for Dapagliflozin Tablets

Lupin Limited announced on April 7, 2026, that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Dapagliflozin Tablets, in 5 mg and 10 mg strengths. These tablets are approved as bioequivalent to Farxiga®, a registered trademark of AstraZeneca AB, for the indications specified in the approved labeling.

The approval allows Lupin to market its Dapagliflozin Tablets in the United States, expanding its product offerings in the anti-diabetic segment. The tablets are intended for use as specified in the approved labeling, providing an alternative to the branded version, Farxiga®. This regulatory approval is part of Lupin’s ongoing efforts to enhance its presence in the U.S. pharmaceutical market, particularly in the generic drug sector.

Lupin is a global pharmaceutical leader with a diverse portfolio that includes branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company operates in over 100 markets worldwide, with a strong focus on key therapeutic areas such as respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health.

With 15 manufacturing sites and 7 research centers globally, Lupin is committed to improving patient health outcomes through its subsidiaries, including Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions. The company’s strategic initiatives are aimed at expanding its product offerings and strengthening its position in key markets like the United States.