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Shilpa Medicare's NorUDCA Makes History as First Approved NAFLD Therapy Worldwide
In a landmark moment for global hepatology and Indian pharmaceutical innovation, Shilpa Medicare Limited (BSE: 530661) (NSE: SHILPAMED) 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.
About this update from Shilpa Medicare Limited
[{"type":"list","items":[{"val":[{"type":"text","content":"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 (NAFLD)","length":175,"tagName":"p"}]},{"val":[{"type":"text","content":"NAFLD affects 1 in 4 people globally (1.2 billion), with 188 million patients in India—most undiagnosed until irreversible damage occurs.","length":147,"tagName":"p"}]},{"val":[{"type":"text","content":"A Breakthrough in Liver Health: NorUDCA delivers a novel dual-action mechanism, combining anti-inflammatory benefits with enhanced bile acid regulation. This innovative therapy promises to halt the progression of NAFLD to severe liver conditions such as NASH, cirrhosis, and liver failure.","length":289,"tagName":"p"}]},{"val":[{"type":"text","content":"Clinically Proven and Safe: Robust clinical trials demonstrate NorUDCA's significant superiority over placebo in efficacy, with an excellent safety profile and no major adverse events reported","length":201,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":812,"olType":false},{"type":"text","content":"RAICHUR, India, Aug. 14, 2025 /PRNewswire/ -- In a landmark moment for global hepatology and Indian pharmaceutical innovation, Shilpa Medicare Limited (BSE: 530661) (NSE: SHILPAMED) 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.","length":413,"tagName":"p"},{"type":"image","alt":"Shilpa Medicare Logo","displaySize":"","headline":null,"caption":"Shilpa Medicare Logo","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":126,"url":"https://media.zenfs.com/en/prnewswire.com/f939b94993067bbf4761a4f4b89263c3"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/alvVE1_m1Bo0TFjZ51v.gg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTIyMjtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/f939b94993067bbf4761a4f4b89263c3","width":400,"height":126}}},{"type":"text","content":"Mr. Vishnukant Bhutada, Managing Director, Shilpa Medicare, hailed the approval as a "transformational leap":","length":129,"tagName":"p"},{"type":"text","content":""Receiving approval for NorUDCA m...