Mumbai, April 8 -- The drug is the generic version of Farxiga(R) Tablets, 5 mg and 10 mg. It is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. The tablets will be manufactured at the group's formulation facility at SEZ, Ahmedabad.

According to IQVIA MAT February 2026 data, Dapagliflozin tablets had annual sales of $10.2 billion in the United States. With this approval, Zydus is eligible for 180 days of shared generic drug exclusivity. The group now has 436 USFDA approvals and has filed 505 ANDAs since it began filing in FY2003-04.

Zydus Lifesciences operates as an integrated pharmaceutical company across research, devel...