Shilpa Medicare's NorUDCA Achieves Milestone as First Approved NAFLD Therapy

Shilpa Medicare's Breakthrough with NorUDCA

In a landmark announcement, Shilpa Medicare Limited has received regulatory approval for Nor Ursodeoxycholic Acid (NorUDCA), marking it as the world’s first ever therapy approved for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD). This significant achievement promises to bring hope to more than one billion individuals globally who are suffering from this condition, including a staggering 188 million in India alone.

Understanding NAFLD

NAFLD affects approximately one in four individuals worldwide, yet many remain undiagnosed until irreversible liver damage occurs. The lack of effective treatment options has made this one of the leading challenges in liver health. NorUDCA presents a vital turning point, utilizing a novel dual-action mechanism that combines anti-inflammatory properties with enhanced regulation of bile acids. This innovative approach not only aims to halt the progression of NAFLD but also helps prevent severe liver conditions such as Nonalcoholic Steatohepatitis (NASH), cirrhosis, and liver failure.

Clinical Trials and Safety Profile

Clinical trials have demonstrated the significant effectiveness of NorUDCA, showcasing its superiority over placebo with an excellent safety profile. Notably, no serious adverse events have been reported during these trials, reinforcing the therapy's promise as a safe option for patients. This robust clinical evidence supports the administration of NorUDCA as a transformative treatment for individuals grappling with the silent threats of liver disease.

Shilpa Medicare's Vision

Vishnukant Bhutada, Managing Director of Shilpa Medicare, heralded the approval of NorUDCA as a transformative leap for not just the company but for millions silently suffering from liver disease. He expressed honor at being the first company globally to provide this innovative therapy, emphasizing their commitment to developing new health solutions and improving access to life-altering treatments in India and beyond. The company is poised to launch NorUDCA promptly in India while actively pursuing worldwide approvals to ensure accessibility to this vital therapy.

About Shilpa Medicare

Founded as a fully integrated pharmaceutical enterprise, Shilpa Medicare specializes in developing innovative APIs for oncology and non-oncology, along with peptides, polymers, novel biologics, and differentiated dosage forms like orally disintegrating films and transdermal patches. The company supports global pharma partners with comprehensive CDMO services, driven by four advanced research and development centers and seven manufacturing facilities, all aimed at consistently advancing healthcare innovation and quality.

As the world watches, Shilpa Medicare stands as a beacon of hope in the fight against NAFLD, illustrating the possibilities that arise through dedicated research, innovation, and a genuine commitment to patient health worldwide.