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Zydus Lifesciences gets USFDA’s approval for ‘Dapagliflozin Tablets’
Apr-08-2026

Zydus Lifesciences has secured final 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.

With this approval, the company is eligible for 180 days of shared generic drug exclusivity for Dapagliflozin Tablets, 5 mg and 10 mg. Dapagliflozin tablets will be manufactured at the group’s formulation manufacturing facility at SEZ, Ahmedabad. The group now has 436 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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