Shilpa Medicare Limited — Important, 09-08-2025: Product launch

Shilpa Medicare has received approval from CDSCO for its Nor Ursodeoxycholic Acid (NorUDCA) Tablets 500 mg for Non-Alcoholic Fatty Liver Disease (NAFLD) in India. This marks Shilpa as the first company globally to launch this novel product for NAFLD. This breakthrough addresses a significant unmet medical need, as NAFLD impacts an estimated 188 million individuals in India. NorUDCA demonstrated superior efficacy over placebo with no significant safety concerns, showing improved liver structure and function. This approval reinforces Shilpa's dedication to innovation and accessible healthcare, allowing for immediate introduction in India and supporting global regulatory efforts.