Zydus Life gets USFDA nod for empagliflozin and linagliptin tablets

28 Nov 2025 , 01:34 PM

Zydus Lifesciences Ltd announced that it has secured tentative approval from the United States Food and Drug Administration (FDA) for empagliflozin and linagliptin tablets. These shall be available in strengths of 10 mg/5 mg and 25 mg/5 mg. These tablets are biosimilar to Glyxambi tablets, 10 mg/5 mg and 25 mg/5 mg.

At around 1.24 PM, Zydus Lifesciences was trading 0.32% higher at ₹940.25, against the previous close of ₹937.25 on NSE. The counter touched an intraday high and low of ₹947.95, and ₹936.50, respectively.

The combination of empagliflozin and linagliptin is used as a supplement to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate. The company plans to manufacture these tablets at its formulation manufacturing facility situated in the SEZ in Ahmedabad.

Empagliflozin and linagliptin tablets registered an annual sales of $215.8 Million in the United States for the period ended September 2025, according to IQVIA MAT data. With this approval, the group now has secured 428 approvals and has filed 487 ANDAs since the beginning of the filing process in FY2003-04.

In its results for the quarter ended September 2025, the business posted a net profit of ₹1,259 Crore. This came in 39% year-on-year higher against ₹911 Crore in the previous corresponding period.

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