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Zydus Cadila gets an approval from USFDA to market Ursodiol capsules

October 19, 2020

In a statement, Zydus Cadila said that the company has received final approval from the US Food and Drug Administration (USFDA) for the medication in 300 mg strength. They got an approval from the US health regulator to market Ursodiol capsules, used to treat primary biliary cirrhosis. 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.

Apart from this, the company 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.


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