Zydus receives tentative approval from USFDA for Empagliflozin and Linagliptin Tablets, 10 mg/5 mg and 25 mg/5 mg

Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as "Zydus") has received tentative approval from the United States Food and Drug Administration (USFDA) for Empagliflozin and Linagliptin Tablets, 10 mg/5 mg and 25 mg/5 mg (USRLD: Glyxambi® Tablets, 10 mg/5 mg and 25 mg/5 mg).

Empagliflozin and Linagliptin Tablets (10 mg/5 mg and 25 mg/5 mg) in a combination are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate.

Empagliflozin and Linagliptin Tablets will be produced at the group's formulation manufacturing facility at SEZ, Ahmedabad.

Empagliflozin and Linagliptin Tablets had annual sales of USD 215.8 mn in the United States (IQVIA MAT Sept-2025).

The group now has 428 approvals and has so far filed 487* ANDAs since the commencement of the filing process in FY 2003-04.

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 937.25 as compared to the previous close of Rs. 940.45. The total number of shares traded during the day was 11491 in over 1290 trades.

The stock hit an intraday high of Rs. 949.25 and intraday low of 929.20. The net turnover during the day was Rs. 10787905.00.

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 Pharmaceuticals TentativeApproval USFDA EMpagliflozin Linagliptin