Shilpa Medicare Limited has informed the Exchange about announces the approval of Nor Ursodeoxycholic Acid Tablets 500 mg for the treatment of Non-Alcoholic Fatty Liver Disease in India
SHILPAMED · price
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Awaiting price reaction for this filing.
Shilpa Medicare has received approval from India's drug regulator (CDSCO) for Nor Ursodeoxycholic Acid (NorUDCA) Tablets 500 mg to treat Non-Alcoholic Fatty Liver Disease (NAFLD). The company claims this makes it the first company in the world to get approval for NorUDCA in this specific use case, and it plans to launch the product in India immediately. NAFLD affects roughly 188 million people in India and about 25% of the global population, representing a large addressable market. Clinical data cited by the company showed superior efficacy over placebo with no significant safety concerns.
This is a positive development for Shilpa Medicare as it opens a new revenue stream in a large, underserved therapeutic area and gives the company a first-mover advantage globally. Near-term stock reaction may be positive, though actual financial contribution will depend on launch execution, pricing, and adoption rates.