Lupin Limited has received approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dapagliflozin Tablets in 5 mg and 10 mg strengths, marking another strategic addition to its diabetes care franchise in the United States. 

The approved tablets are bioequivalent to AstraZeneca’s Farxiga® and will be marketed for the indications covered under the approved labeling in the U.S.

This approval is expected to bolster Lupin’s presence in the high-growth anti-diabetic therapy segment, where SGLT2 inhibitors such as dapagliflozin are witnessing rising demand due to their expanding use in diabetes, heart failure, and kidney disease management. 

For Lupin, the latest clearance aligns with its strategy of deepening its footprint in complex generics and chronic therapies, particularly in the U.S., one of its most significant global markets. The company already maintains a strong franchise across respiratory, cardiovascular, anti-diabetic, and women’s health segments. 

Headquartered in Mumbai, Lupin operates across more than 100 markets with 15 manufacturing sites and seven research centres worldwide. The company continues to leverage its scale in generics and specialty medicines to expand access to affordable therapies globally.