Shilpa Medicare’s Liver Lifesaver: NorUDCA Approved as World’s First NAFLD Drug

In a groundbreaking development for global hepatology and Indian pharmaceutical innovation, Shilpa Medicare Ltd has secured the world’s first regulatory approval for Nor Ursodeoxycholic Acid (NorUDCA) Tablets 500 mg, marking the first-ever approved therapy for Non-Alcoholic Fatty Liver Disease (NAFLD). The approval was granted by India’s Central Drugs Standard Control Organization (CDSCO), positioning Shilpa Medicare as a global pioneer in liver disease treatment.

 

A Global Milestone in Liver Health

NAFLD is the most prevalent liver condition worldwide, affecting nearly 1.2 billion people—roughly 25% of the global population. In India alone, an estimated 188 million individuals suffer from NAFLD, many of whom remain undiagnosed until the disease progresses to more severe conditions such as non-alcoholic steatohepatitis (NASH), cirrhosis, or liver failure.

 

Until now, there was no approved pharmacological therapy specifically targeting NAFLD. Shilpa Medicare’s NorUDCA changes that narrative, offering a first-in-class treatment that combines choleretic and anti-inflammatory properties to enhance bile flow, reduce hepatic inflammation, and halt disease progression.

 

Clinical Efficacy and Safety

Robust clinical trials have demonstrated NorUDCA’s superior efficacy over placebo, with significant improvements in liver structure and function. Importantly, the drug has shown an excellent safety profile, with no major adverse events reported. This positions NorUDCA as a promising therapeutic option not only for NAFLD but also for associated cholestatic liver disorders.

 

Leadership Speaks

Vishnukant Bhutada, Managing Director of Shilpa Medicare, hailed the approval as a “transformational leap” for both the company and the millions affected by liver disease:

 

“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.”

 

Shilpa Medicare plans to immediately launch NorUDCA in India, while actively pursuing global regulatory approvals to ensure the therapy reaches patients worldwide.

 

Innovation at the Core

Founded in Raichur, Karnataka, Shilpa Medicare has evolved into a fully integrated pharmaceutical group specializing in Oncology and Non-Oncology APIs, Peptides, Polymers, and New Biological Entities. The company also offers end-to-end CDMO services to global pharmaceutical partners, supported by four advanced R&D centers and seven manufacturing facilities.

 

This latest achievement underscores Shilpa’s commitment to addressing unmet medical needs through innovation and evidence-based solutions. The approval of NorUDCA is not just a win for the company—it’s a win for global healthcare.

 

Market Impact

Following the announcement, Shilpa Medicare’s shares gained modestly, closing 0.3% higher at ₹825 on the BSE. While the stock has seen some volatility in recent months, analysts believe the NorUDCA approval could act as a long-term growth catalyst, especially as the company expands its global footprint.

 

What’s Next?

With NorUDCA now approved, Shilpa Medicare is expected to:

The approval also opens doors for Shilpa to lead future innovations in liver health, potentially expanding its pipeline to address other hepatic and metabolic disorders.

 

Sources: ThePrint, Medical Dialogues, CNBC-TV18