Shilpa Medicare Receives Approval for Nor Ursodeoxycholic Acid Tablets for NAFLD Treatment in India

Shilpa Medicare Limited has announced the approval of Nor Ursodeoxycholic Acid (NorUDCA) Tablets 500 mg by the Central Drugs Standard Control Organization (CDSCO) in India for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD). This approval marks a significant milestone in innovative NAFLD therapy in India and allows Shilpa Medicare to become the first company globally to launch this novel product for NAFLD. NorUDCA is the first-in-class treatment for NAFLD in India, addressing a significant unmet medical need affecting approximately 188 million individuals in India alone. NorUDCA demonstrated superior efficacy over placebo, with no significant safety concerns identified. The company plans to immediately introduce NorUDCA tablets in India and advance global regulatory efforts to bring this vital therapy to patients internationally.