Zydus Lifesciences Secures Final USFDA Approval for Dapagliflozin Tablets
Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for Dapagliflozin Tablets in strengths of 5 mg and 10 mg. The drug, which is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.With this significant achievement, Zydus is now eligible for 180 days of shared generic drug exclusivity for Dapagliflozin Tablets, 5 mg and 10 mg.
Dapagliflozin tablets will be manufactured at the group's formulation manufacturing facility located at SEZ, Ahmedabad. The market potential for this drug remains substantial, given that Dapagliflozin tablets generated annual sales of USD 10.2bn in the United States, according to IQVIA MAT data for February 2026.
The company's pipeline achievements are robust. Zydus now holds 436 approvals and has filed 505* ANDAs since beginning the filing process in FY 2003-04.
The company's details include the following exchange listings:
| Exchange | Code |
|---|---|
| BSE Limited | 532321 |
| National Stock Exchange of India Limited | Zyduslife |
ZYDUSLIFE Stock Price Movement
As of 9:47 AM, shares of Zydus Lifesciences Limited are rallying, pushing the stock up 1.29% to ₹884.8 in live trading. The equity is attracting significant interest, trading on a volume of 98,838 shares.Source:
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