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Zydus Lifesciences gets USFDA’s tentative nod for Dapagliflozin tablets
Feb-04-2026

Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Dapagliflozin Tablets, 5 mg and 10 mg (USRLD: Farxiga Tablets, 5 mg and 10 mg). Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.

Dapagliflozin tablets will be manufactured at the group’s formulation manufacturing facility at SEZ, Ahmedabad. Dapagliflozin tablets had annual sales of $10,486.9 million in the United States (IQVIA MAT December 2025). The group now has 430 approvals and has so far filed 505 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.


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