Ursodiol is in a class of medications called gallstone dissolution agents. It is used to treat people with primary biliary cirrhosis, an autoimmune liver disease.
The company said it has also received tentative approval from USFDA to market Linagliptin and Metformin Hydrochloride tablets in multiple strengths.
The medication 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, Zydus Cadila said.
The Ahmedabad-based group now has 307 approvals and has so far filed over 390 Abbreviated New Drug Applications (ANDAs) since the commencement of the filing process in 2003-04.