Zydus Cadila gets tentative approval from USFDA for Linagliptin Tablets

29 Oct 2020 Evaluate

Zydus Cadila has received tentative approval from the USFDA to market Linagliptin Tablets, 5 mg (US RLD: Tradjenta Tablets). Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus.

The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.

The group now has 310 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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