Zydus Lifesciences Gains Tentative USFDA Approval for Dapagliflozin
Filing Summary
Zydus Lifesciences Ltd has received tentative approval from the United States Food and Drug Administration for its Dapagliflozin Tablets, available in 5 mg and 10 mg dosages. This approval pertains to a sodium-glucose cotransporter 2 inhibitor used to enhance glycaemic control in adults with type 2 diabetes mellitus. The tablets will be produced at Zydus’s manufacturing facility in Ahmedabad. The product had annual sales of USD 10487 million in the United States as of December 2025. Zydus has secured 430 approvals and filed 505 ANDAs since FY 2003-04.
Zydus Lifesciences Ltd has received tentative approval from the United States Food and Drug Administration (USFDA) for its Dapagliflozin Tablets, in 5 mg and 10 mg dosages. The approval is for a sodium-glucose cotransporter 2 (SGLT2) inhibitor, which is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.
The Dapagliflozin Tablets will be manufactured at Zydus’s formulation manufacturing facility located at SEZ, Ahmedabad. According to IQVIA MAT December 2025 data, Dapagliflozin tablets had annual sales of USD 10487 million in the United States.
Zydus has now achieved 430 approvals and has filed a total of 505 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, including active pharmaceutical ingredients and formulations. Zydus continues to expand its product portfolio and regulatory approvals to enhance its presence in the global pharmaceutical market.