Shilpa Medicare Limited (BSE:530549) (NSE:SHILPAMED), an India-based API and formulation manufacturer, announced on Wednesday that it has received approval from the Subject Expert Committee (SEC) of India's Central Drugs Standard Organisation (CDSCO) for its Investigational New Drug (IND) application for Nor Ursodeoxycholic Acid (Nor UDCA) Tablets 500 mg.

The product was recommended for marketing authorisation for treating non-alcoholic fatty liver disease (NAFLD).

Shilpa Medicare had earlier completed phase 3 clinical studies of this novel product SMLNUD07 -- Nor Ursodeoxycholic Acid (Nor UDCA) tablets -- and presented to the SEC the results of the trial titled 'A phase III, Randomized, Double- Blind, placebo controlled, multicentre, Parallel group study', evaluating the safety and efficacy of Nor-Ursodeoxycholic Acid 500 mg in patients with NAFLD.

The trial met all primary efficacy endpoints, demonstrating a significant improvement in fatty liver stage. Key findings included 83.3% of participants showing fibrosis reversal, with stabilisation in the rest, and elevated alanine transaminase (ALT) levels, a key NAFLD marker, normalised in approximately 90% of participants within 12 weeks.

The company said that 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.