Zydus Lifesciences Limited 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 u). Empagliflozin & Linagliptin Tablets (10 mg/5 mg and 25 u/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. Empagliflozinand Linagliptin Tablets will be produced at the group's formulation manufacturing facility at SEZ, Ahmedabad.
Empag liflozin and Linagli molecule 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 fiscal 2003-04.
