Zydus Lifesciences Ltd.

Zydus Lifesciences 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, 10mg/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 $215.8 million 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. 

Zydus Lifesciences (formerly known as Cadila Healthcare), a company limited by shares, incorporated and domiciled in India, operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products.