Zydus Lifesciences Gains USFDA Tentative Approval for Diabetes Tablets
Filing Summary
Zydus Lifesciences Ltd has received tentative approval from the USFDA for its Empagliflozin and Linagliptin Tablets in 10 mg/5 mg and 25 mg/5 mg dosages. These tablets are intended to aid glycaemic control in adults with type 2 diabetes mellitus. The tablets will be manufactured at Zydus’s facility in Ahmedabad. The product had annual sales of USD 216 million in the US as of September 2025. Zydus has accumulated 428 approvals and filed 487 ANDAs since FY 2003-04.
Zydus Lifesciences Ltd has received tentative approval from the USFDA for its Empagliflozin and Linagliptin Tablets in 10 mg/5 mg and 25 mg/5 mg dosages. The approval pertains to the use of these tablets 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.
The tablets will be manufactured at the group’s formulation manufacturing facility located at SEZ, Ahmedabad. According to IQVIA MAT data from September 2025, the product had annual sales of USD 216 million in the United States.
Zydus has now secured a total of 428 approvals and has filed 487 Abbreviated New Drug Applications (ANDAs) since the commencement of the filing process in the fiscal year 2003-04.
Zydus Lifesciences Ltd focuses on the development, manufacturing, and marketing of a wide range of healthcare products. The company is engaged in the production of pharmaceuticals, diagnostics, and wellness products, aiming to address various therapeutic areas. Zydus continues to expand its product portfolio through strategic approvals and filings in key markets.