Shilpa Medicare Ltd has announced the launch of NorUDCA tablets in India, the world’s first approved treatment for Non-Alcoholic Fatty Liver Disease (NAFLD). This breakthrough addresses a vast unmet medical need, as NAFLD affects over 188 million people in India alone. Shilpa Medicare pioneers a new chapter in liver health management with this innovative dual-action therapy.
Shilpa Medicare Ltd has proudly launched NorUDCA (Nor Ursodeoxycholic Acid) tablets in India, marking a historic first globally for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD). This milestone follows regulatory approval by India's Central Drugs Standard Control Organization (CDSCO).
Key Highlights:
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Global Pioneer: Shilpa Medicare is the first company worldwide to launch NorUDCA, a novel first-in-class treatment for NAFLD.
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Addressing a Critical Need: NAFLD affects about 25% of the global population (~1.2 billion) and 188 million in India, many undiagnosed until serious complications arise.
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Innovative Therapy: NorUDCA combines anti-inflammatory effects with enhanced bile acid regulation to prevent disease progression to severe liver conditions such as NASH, cirrhosis, and liver failure.
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Strong Clinical Backing: Clinical trials demonstrate NorUDCA’s superior efficacy and safety compared to placebo, with no major adverse events.
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Leadership Vision: Vishnukant Bhutada, Managing Director of Shilpa Medicare, called this a “transformational leap,” emphasizing the company’s commitment to accessible, life-changing healthcare solutions for millions in India and globally.
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Future Growth: Revenue generation from NorUDCA sales is expected from Q3 FY2026, with ongoing efforts to secure global regulatory approvals.
Shilpa Medicare’s launch of NorUDCA opens a new frontier in liver disease treatment, transforming patient outcomes and reinforcing India’s role in pharmaceutical innovation.
Sources Shilpa Medicare official press releases, CDSCO announcements, Business Standard, PR Newswire