Zydus Cadila gets final approval from USFDA for Ursodiol Capsules

17 Oct 2020 Evaluate

Zydus Cadila has received final approval from the USFDA to market Ursodiol Capsules USP, 300 mg (US RLD: Actigall Capsules). Ursodiol is in a class of medications called gallstone dissolution agents. It is used to treat people with primary biliary cirrhosis (PBC; an autoimmune liver disease).

The company also received tentative approval from the USFDA to market Linagliptin and Metformin Hydrochloride Tabs (US RLD: Jentadueto Tablets) in the strengths of 2.5 mg/500 mg, 2.5 mg/850 mg, and 2.5 mg/1,000 mg. It is used along with diet and exercise to improve control of blood sugar levels in adults with type 2 diabetes mellitus.

Both drugs will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.

The group now has 307 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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