Zudus Cadila has got the final approval from the USFDA to market Ursodiol Capsules USP, 300 mg. 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 drug regulator 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.