India-based global pharmaceutical company Shilpa Medicare Limited (BSE:530661, NSE:SHILPAMED) announced on Thursday that it has obtained the world's first regulatory approval for Nor Ursodeoxycholic Acid (NorUDCA) Tablets - a drug targeting the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) - from India's Central Drugs Standard Control Organisation.

This marks the first approved treatment for NAFLD, a condition affecting 1.2 billion people globally, including 188 million in India. NAFLD often goes undiagnosed until irreversible damage occurs, progressing to conditions such as Non-Alcoholic Steatohepatitis, cirrhosis, and liver failure.

Delivered in a 500 mg dose, NorUDCA employs a dual-action mechanism that combines anti-inflammatory benefits with enhanced bile acid regulation, aiming to halt disease progression.

Shilpa Medicare claims that clinical trials have demonstrated NorUDCA's superiority over placebo in efficacy, with a strong safety profile and no major adverse events reported. The company plans to launch the product immediately in India and pursue regulatory approvals in other markets.