Shilpa Medicare gets CDSCO green light for Non-Alcoholic Fatty Liver Disease treatment

Shilpa Medicare Limited has received approval from the Central Drugs Standard Control Organization (CDSCO) for Nor Ursodeoxycholic Acid (NorUDCA) Tablets 500 mg, for the treatment of Non‐Alcoholic Fatty Liver Disease (NAFLD) in India. 

This approval will allow Shilpa to become the first company in the World to launch this novel product in any part of the World for NAFLD.

NorUDCA is the first‐in‐class treatment for Non‐alcoholic Fatty Liver Disease (NAFLD) in India, addressing a significant unmet medical need. NAFLD is currently the most prevalent liver condition globally, affecting about 25% of the world’s population (approximately 1.2 billion people) and impacting an estimated 188 million individuals in India alone. If not managed early, NAFLD may progress to non‐alcoholic steatohepatitis (NASH) and severe liver complications, underscoring the urgent necessity for effective therapy. These results collectively demonstrate a significant improvement in both liver structure and function, confirming NorUDCA’s superior efficacy compared to placebo in NAFLD.