Zydus Cadila’s Sitagliptin base tablets gets tentative approval from USFDA

06 Sep 2021 Evaluate

Zydus Cadila’s Sitagliptin base tablets has received tentative approval from the United States Food and Drug Administration (USFDA) for its new drug application for Sitagliptin base 25, 50 and 100 mg tablets. Zydus’ Sitagliptin base contains the active moiety Sitagliptin in a different form than used in the branded reference product, Januvia (Sitagliptin Phosphate).

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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