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Zydus Cadila gets tentative approval from USFDA for Dapagliflozin Tablets
Oct-29-2020

Zydus Cadila has received tentative approval from the USFDA to market Dapagliflozin Tablets, 5 mg and 10 mg (US RLD: Farxiga Tablets). Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors.

The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.The group now has 311 approvals and has so far filed over 390 ANDAs since the commencement of the filing process in FY 2003-04.

Cadila Healthcare is an India-based pharmaceutical company. The company's subsidiaries include Zydus Wellness, Liva Pharmaceuticals, Biochem Pharmaceutical Industries, Zydus Technologies, German Remedies, Dialforhealth India, Dialforhealth Unity and Dialforhealth Greencross, among others.

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