PRNewswire
Raichur (Karnataka) [India], August 14: 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.
* 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–most 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 trials demonstrate NorUDCA’s significant superiority over placebo in efficacy, with an excellent safety profile and no major adverse events reported
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 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
About Shilpa Medicare Limited:
Shilpa Medicare Limited is a fully integrated pharmaceutical group specializing in innovative Oncology and Non-Oncology APIs, Peptides, Polymers, New 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
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