Shilpa Pharma Lifesciences received CEP from EDQM for ursodeoxycholic acid
Drug Approval

Shilpa Pharma Lifesciences received CEP from EDQM for ursodeoxycholic acid

Ursodeoxycholic acid or ursodiol is a naturally occurring bile acid that is used dissolve cholesterol gall stones

  • By IPP Bureau | August 01, 2024

Shilpa Medicare Limited's 100% subsidiary, Shilpa Pharma Lifesciences Limited received certificate of suitability (CEP) from EDQM (European Directorate for the Quality of Medicines & Healthcare) for API, Ursodeoxycholic Acid.

Ursodeoxycholic acid or ursodiol is a naturally occurring bile acid that is used dissolve cholesterol gall stones and to treat cholestatic forms of liver diseases including primary biliary cirrhosis.

Ursodiol has been linked to rare instances of transient and mild serum aminotransferase elevations during therapy and to rare instances of jaundice and worsening of liver disease in patients with preexisting cirrhosis.

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