Shilpa Medicare Limited , a leading API and formulation manufacturer, announces that the Subject Expert Committee (SEC) of CDSCO has approved its Investigational New Drug (IND) – Nor Ursodeoxycholic Acid (Nor UDCA) Tablets 500 mg – and recommended marketing authorization for treating non-alcoholic fatty liver disease (NAFLD).

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

Shilpa Medicare Ltd. had earlier completed phase-3 clinical studies of this novel product SMLNUD07 – 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.

The trial met all primary efficacy endpoints, demonstrating a significant improvement in fatty liver stage. Key findings include:

• Liver Fibrosis Reversal: 83.3% of participants showed fibrosis reversal, with stabilization in the rest.
• ALT Normalization: Elevated alanine transaminase (ALT) levels, a key NAFLD marker, normalized in ~90% of participants within 12 weeks.

These results position Nor UDCA as a breakthrough therapy for NAFLD, offering advantages over conventional UDCA, including enhanced choleretic effect, resistance to amidation, anti-inflammatory properties, and fibrosis reduction.

Commenting on the development, Mr. Vishnukant Bhutada – Managing Director, Shilpa Medicare Limited, said, "We are very pleased with this approval from SEC and hope to get the marketing approval soon. We are committed to working closely with regulatory authorities to bring this innovative treatment to patients as quickly as possible and are hopeful of launching it in India in the coming financial year. This NCE molecule approval exemplifies the true spirit of Shilpa, 'Innovating for affordable healthcare', keeping in mind the unmet needs of a large patient pool. Based on the approval in India, we plan to reach out to Global regulatory authorities to seek scientific advice for introduction of this novel product internationally."

Founded in 1987, Shilpa Medicare offers APIs, Formulations, and Biologics, with facilities approved by major regulatory agencies. The company is also recognized for providing complete turnkey CDMO solutions for clients globally.