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

Not only does this approval help address a significant unmet medical need in hepatology, but it also positions Shilpa as the first company in the world to launch this novel therapy for NAFLD.

"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,” said Vishnukant Bhutada, Managing Director, Shilpa Medicare.

“This milestone is a moment of immense pride for Shilpa and the nation, as we now pioneer the launch of its finished dosage form,” he added.  

The company plans to introduce NorUDCA tablets in India immediately while pursuing global regulatory pathways to expand access internationally.

NAFLD is currently the most prevalent liver condition globally, affecting about 25 percent 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. Alarmingly, most patients in India remain undiagnosed until irreversible damage occurs.

NorUDCA offers a novel dual-action mechanism, combining anti-inflammatory benefits with enhanced bile acid regulation. This innovative therapy promises to halt the progression of NAFLD to severe liver conditions such as NASH, cirrhosis, and liver failure.

Clinical trials have demonstrated NorUDCA's superior efficacy compared to placebo in NAFLD, with an excellent safety profile and no major adverse events reported.

Headquartered in Raichur, Karnataka, Shilpa Medicare is a fully integrated pharmaceutical group specialising in innovative oncology and non-oncology APIs, peptides, polymers, new biological entities, and differentiated finished dosage formulations such as orally dispersible films and transdermal patches. The company also provides end-to-end CDMO services to global pharmaceutical partners, supported by four advanced research and development centers and seven manufacturing facilities.