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

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-08-11T14:32:31+05:30 | Updated On 11 Aug 2025 2:32 PM IST

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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.

Nor UDCA demonstrated superior efficacy over placebo, and no significant safety concerns were identified. NorUDCA is uniquely positioned with its choleretic and anti‐inflammatory properties, enhancing bile flow, reducing hepatic inflammation, and offering therapeutic potential in halting the progression of NAFLD and associated cholestatic liver disorders.

Commenting on this approval, Vishnukant Bhutada, Managing Director, Shilpa Medicare Limited, said, "We are delighted to receive historic approval for NorUDCA, India’s first‐in‐class therapy for NAFLD—making Shilpa the first company globally to obtain approval for NorUDCA in this indication. This milestone is a moment of immense pride for Shilpa and the nation, as we now pioneer the launch of its finished dosage form. This breakthrough exemplifies Shilpa’s unwavering dedication to innovation and accessible healthcare to millions battling liver disease in India and beyond. We are excited to introduce NorUDCA tabletsin India immediately, while advancing global regulatory efforts to bring this vital therapy to patients internationally."

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751