Shilpa Medicare emerges as the global pioneer to receive approval for NorUDCA, offering new hope to over a billion people affected by Non-Alcoholic Fatty Liver Disease
In a landmark moment for global hepatology and Indian pharmaceutical innovation, Shilpa Medicare Limited has secured 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-ever approved therapy targeting NAFLD.
Mr. Vishnukant Bhutada, Managing Director, Shilpa Medicare, hailed the approval as a “transformational leap”:
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“Receiving approval for NorUDCA marks a transformational leap—not only for Shilpa Medicare but for millions silently suffering from liver disease. We are honored to be the first company globally to bring this innovative therapy to patients, reflecting our unwavering commitment to pioneering healthcare solutions and expanding access to life-changing treatments across India and beyond. We are excited to launch NorUDCA in India immediately and are actively pursuing approvals worldwide to ensure this vital therapy reaches patients everywhere in need.”
Shilpa Medicare is committed to rapidly commercializing NorUDCA in India and pursuing international regulatory pathways, aiming to bring this life-altering treatment to patients on a global scale
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Source- PR Newswire
