{"id":34647,"date":"2025-03-11T21:30:00","date_gmt":"2025-03-11T21:30:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4637806_AE37806_0"},"modified":"2025-03-11T21:30:00","modified_gmt":"2025-03-11T21:30:00","slug":"shilpa-medicare-secures-sec-cdsco-nod-for-nor-ursodeoxycholic-acid-tablets-eyes-market-launch-for-nash","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=34647","title":{"rendered":"Shilpa Medicare Secures SEC-CDSCO Nod for Nor-Ursodeoxycholic Acid Tablets, Eyes Market Launch for NASH"},"content":{"rendered":"\n\n\n
<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

RAICHUR, India <\/span>, March 12, 2025<\/span><\/span> \/PRNewswire\/ — Shilpa Medicare Limited<\/a> (BSE: 530549) (NSE: SHILPAMED), a leading API and formulation manufacturer, announces that the Subject Expert Committee (SEC) of CDSCO has approved its Investigational New Drug (IND) \u2013 Nor Ursodeoxycholic Acid (Nor UDCA) Tablets 500 mg \u2013 and recommended marketing authorization for treating non-alcoholic fatty liver disease (NAFLD).<\/p>\n

NAFLD, the most prevalent liver disease, affects approximately 25% of the global population (1.2 billion people), including 188 million in India<\/span>. Left untreated, NAFLD can progress to non-alcoholic steatohepatitis (NASH), a severe and potentially fatal condition.<\/p>\n

Shilpa Medicare Ltd. had earlier completed phase-3 clinical studies of this novel product SMLNUD07 \u2013 Nor Ursodeoxycholic Acid (Nor UDCA) tablets – and presented the results of the trial titled, “A phase – III, Randomized, Double- Blind, placebo controlled, multicenter, Parallel group study”, to evaluate the safety and efficacy of Nor-Ursodeoxycholic Acid 500 mg in patients suffering from Non-alcoholic Fatty Liver Disease to the SEC.<\/p>\n

The trial met all primary efficacy endpoints, demonstrating a significant improvement in fatty liver stage. Key findings include:<\/b><\/p>\n