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Shilpa Medicare's NorUDCA Makes History as First Approved NAFLD Therapy Worldwide
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....hilpa Medicare's NorUDCA Makes History as First Approved NAFLD Therapy Worldwide<BR>PTI News<BR>Dated:- 14-8-2025<BR>PTI<BR>• 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) • NAFLD affects 1 in 4 people globally (1.2 billion), with 188 million patients in India—m....
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....ost undiagnosed until irreversible damage occurs. • 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. • Clinically Proven and Safe: Robust clinical tria....
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....ls demonstrate NorUDCA's significant superiority over placebo in efficacy, with an excellent safety profile and no major adverse events reported 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 ....
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....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": "Receiving approval for NorUDCA marks a transformational leap—not only for Shilpa Medicare but for millions silently suffering from live....
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....r 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 eve....
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....rywhere 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 About Shilpa Medicare Limited: Shilpa Medicare Limited is a fully integrated pharmaceutical group specializing in innovative Oncology and Non-Oncology APIs, Peptides, Polymers, New....
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.... Biological Entities and differentiated finished dosage formulations such as Orally Dispersible Films and Transdermal Patches. The company offers end-to-end CDMO services to global pharmaceutical partners, supported by four advanced R&D centers and seven manufacturing facilities, consistently driving innovation and quality in healthcare. www.vbshilpa.com Logo - https://mma.prnewswire.com/media/2....
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....489785/Shilpa_Logo.jpg' alt='Embedded Media' /> (Disclaimer: The above press release comes to you under an arrangement with PRNewswire and PTI takes no editorial responsibility for the same.). PTI<BR> News - Press release - PIB....