Shilpa Medicare Leads Global Innovation with First-Ever NorUDCA Approval
Shilpa Medicare Limited has secured the world's first regulatory approval for NorUDCA, a groundbreaking therapy for NAFLD, from India's CDSCO. As an innovative leader in hepatology, the company aims to rapidly launch the drug in India and pursue international approvals, expanding access to life-changing treatments worldwide.

- Country:
- India
In a significant breakthrough, Shilpa Medicare Limited has achieved a pioneering milestone by securing the world's first regulatory approval for Nor Ursodeoxycholic Acid (NorUDCA) Tablets 500 mg from India's Central Drugs Standard Control Organization (CDSCO). This approval marks the first-ever recognized treatment targeting Non-Alcoholic Fatty Liver Disease (NAFLD).
Shilpa Medicare's Managing Director, Mr. Vishnukant Bhutada, described the approval as a 'transformational leap' for both the company and the millions affected by liver disease. He emphasized the company's commitment to launching NorUDCA in India and is pursuing global regulatory approvals to make this revolutionary treatment accessible worldwide.
Shilpa Medicare specializes in innovative pharmaceutical solutions, focusing on Oncology and Non-Oncology APIs, Peptides, and differentiated dosage formulations. With robust R&D capabilities and manufacturing facilities, the company is dedicated to advancing healthcare innovation and expanding access to life-changing treatments globally.
(With inputs from agencies.)