Zydus Lifesciences Limited has received tentative approval from the United States Food and Drug Administration (USFDA) for Dapagliflozin Tablets, 5 mg and 10 mg. This drug is a sodium-glucose cotransporter 2 (SGLT2) inhibitor used as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. The Dapagliflozin tablets will be manufactured at Zydus's formulation manufacturing facility located at SEZ, Ahmedabad. In the United States, Dapagliflozin tablets had annual sales of USD 10,486.9 million (approximately ₹87,100 crore) as of December 2025, according to IQVIA data. This approval adds to Zydus's portfolio, bringing their total approvals to 430. The company has filed 505 ANDAs (Abbreviated New Drug Applications) since the commencement of its filing process in FY 2003-04, as of December 31, 2025.
