Zydus scores tentative USFDA nod for Empagliflozin, Linagliptin Tablets for diabetes
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-11-27 12:37 GMT | Update On 2025-11-27 12:37 GMT
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Ahmedabad: 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 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
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.
Zydus Lifesciences Ltd. is a global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. Over the last decade, Zydus has introduced several products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and New Chemical Entities.
Read also: Zydus Lifesciences bags USFDA approval for advanced prostatic cancer injection
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