Zydus receives final approval from USFDA for Dapagliflozin Tablets, 5 mg and 10 mg

Zydus Lifesciences Limited ("Zydus") has received final approval from the United States Food and Drug Administration (USFDA) for Dapagliflozin Tablets, 5 mg and 10 mg (USRLD: Farxiga® Tablets, 5 mg and 10 mg).

Dapagliflozin 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. With this approval, Zydus is 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 at SEZ, Ahmedabad. Dapagliflozin tablets had annual sales of USD 10.2bn in the United States (IQVIA MAT February 2026).

The group now has 436 approvals and has so far filed 505 ANDAs as on 31-Dec-2025 since the commencement of the filing process in FY 2003-04.

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 891.55 as compared to the previous close of Rs. 873.65. The total number of shares traded during the day was 45455 in over 4030 trades.

The stock hit an intraday high of Rs. 910.80 and intraday low of 879.90. The net turnover during the day was Rs. 40292758.00.

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 Pharmaceuticals USFDA Approval DapagliflozinTablets