In a landmark achievement for global hepatology and Indian pharmaceutical innovation, Shilpa Medicare Limited has received the world’s first regulatory approval from India’s Central Drugs Standard Control Organization (CDSCO) for Nor Ursodeoxycholic Acid (NorUDCA) Tablets 500 mg—the first approved therapy specifically targeting Non-Alcoholic Fatty Liver Disease (NAFLD).
Mr. Vishnukant Bhutada, Managing Director of Shilpa Medicare, described the approval as a “transformational leap” for liver disease care. “We are honored to be the first company globally to bring this innovative therapy to patients, underscoring our commitment to pioneering healthcare solutions and expanding access to life-changing treatments. With immediate plans to launch in India and active global regulatory pursuits, we aim to ensure this vital therapy reaches patients worldwide.”
The company is set to commercialize NorUDCA in India immediately and accelerate international approvals to bring this breakthrough treatment to those in need across the globe.