#India #Shilpa Medicare #Raichur #NorUDCA #NAFLD

A Historic Milestone in Hepatology

In a significant development for global hepatology and Indian pharmaceutical innovation, Shilpa Medicare Limited has become the first company to gain approval for Nor Ursodeoxycholic Acid (NorUDCA) as a treatment for Non-Alcoholic Fatty Liver Disease (NAFLD) worldwide. This momentous occasion provides renewed hope to over a billion individuals affected by this condition globally, with around 188 million of those living in India alone, many of whom remain undiagnosed until severe liver damage occurs.

What is NAFLD?

NAFLD is a prevalent ailment characterized by fat accumulation in the liver without the influence of alcohol. It affects approximately 1 in 4 individuals globally, often going unnoticed until it progresses to more severe liver diseases such as Non-Alcoholic Steatohepatitis (NASH), cirrhosis, or liver failure. The silent progression of NAFLD can make it a ticking time bomb for many, warranting the need for effective treatments like NorUDCA.

The Breakthrough

NorUDCA offers a novel dual-action mechanism. It combines anti-inflammatory benefits with improved bile acid regulation, aiming to halt the progression of NAFLD to more severe liver conditions. This innovative therapy signifies a leap forward in liver health management, addressing a critical medical need.

The clinical trials surrounding NorUDCA back its effectiveness, demonstrating a significant superiority over placebo in terms of efficacy. Moreover, it boasts a safe profile, with no major adverse events reported during the trials. This firmly establishes NorUDCA as a promising new option for patients.

Shilpa Medicare: A Leader in Pharmaceutical Development

Shilpa Medicare's Managing Director, Mr. Vishnukant Bhutada, described the approval of NorUDCA as a “transformational leap.” He emphasized its significance, stating, "The approval marks a decisive milestone, not just for Shilpa Medicare, but for the millions silently battling liver disease. We are privileged to be the first worldwide to offer this innovative therapy to patients, reflecting our unwavering commitment to health solutions and expanding access to life-changing treatments within India and globally."

Shilpa Medicare is poised to roll out NorUDCA in India without delay and is actively pursuing regulatory approvals internationally. The company’s robust strategy aims to ensure that this vital therapy reaches those in need, regardless of their geographic location.

About Shilpa Medicare Limited

Shilpa Medicare Limited is a fully integrated pharmaceutical group specializing in innovative Active Pharmaceutical Ingredients (APIs) in oncology and non-oncology segments. They focus on peptides, polymers, new biological entities, and differentiated dosage forms, such as orally dispersible films and transdermal patches. With four advanced research and development centers and seven manufacturing sites, Shilpa Medicare continually promotes innovation and quality in healthcare, positioning itself at the forefront of medical advancements.

Shilpa Medicare’s commitment to swiftly commercializing NorUDCA exemplifies its dedication to pioneering treatments that can enhance patients' lives worldwide. As the healthcare landscape evolves, innovative companies like Shilpa Medicare are crucial in bringing much-needed solutions to the forefront of medical care.