Shilpa Medicare Makes Groundbreaking Move with NorUDCA, First NAFLD Therapy Approved Worldwide
In a significant advancement for liver health and the pharmaceutical industry, Shilpa Medicare Limited has achieved a remarkable milestone by being the first organization globally to receive approval for Nor Ursodeoxycholic Acid (NorUDCA) tablets. This breakthrough therapy specifically targets Non-Alcoholic Fatty Liver Disease (NAFLD), which currently impacts approximately 1.2 billion individuals around the world, including 188 million in India alone, many of whom remain undiagnosed until it is too late.
NAFLD, characterized by an accumulation of fat in the liver that is not caused by alcohol consumption, is a prevalent health issue. It can progress to severe conditions such as Non-Alcoholic Steatohepatitis (NASH), cirrhosis, and liver failure, leading to immense health challenges. The urgency for effective treatments has led to the global healthcare community welcoming Shilpa Medicare's new therapy with open arms.
NorUDCA stands out due to its dual-action mechanism that combines anti-inflammatory properties with enhanced bile acid regulation. This innovative approach aims to not just manage symptoms but also halt the progression of NAFLD to more severe liver issues. Preliminary clinical trials reveal that NorUDCA significantly outperformed placebo treatments, showcasing an excellent safety profile without reporting major adverse reactions.
On August 14, 2025, India's Central Drugs Standard Control Organization (CDSCO) approved NorUDCA, marking a historic first in the realm of hepatology. Shilpa Medicare's Managing Director, Mr. Vishnukant Bhutada, called this approval a "transformational leap" for both the company and millions suffering from liver diseases. He expressed pride in being the first globally to offer this innovative treatment, underscoring a commitment to enhance healthcare solutions and broaden access to those in need.
Shilpa Medicare aims to expedite the commercialization of NorUDCA in India while also actively pursuing regulatory approvals in other countries, ensuring that this life-changing therapy can reach as many patients as possible. The company is renowned for its dedication to pharmaceutical innovation, specializing in Oncology and Non-Oncology API treatments, thus bolstering its efforts to provide effective healthcare solutions globally.
As Shilpa Medicare takes this giant leap into the future of liver health, NorUDCA emerges not just as a treatment but as a beacon of hope for numerous individuals worldwide. It represents the potential to change lives and alter the trajectory of NAFLD management, one patient at a time.
What is NAFLD?
NAFLD, characterized by an accumulation of fat in the liver that is not caused by alcohol consumption, is a prevalent health issue. It can progress to severe conditions such as Non-Alcoholic Steatohepatitis (NASH), cirrhosis, and liver failure, leading to immense health challenges. The urgency for effective treatments has led to the global healthcare community welcoming Shilpa Medicare's new therapy with open arms.
NorUDCA: A Novel Therapy
NorUDCA stands out due to its dual-action mechanism that combines anti-inflammatory properties with enhanced bile acid regulation. This innovative approach aims to not just manage symptoms but also halt the progression of NAFLD to more severe liver issues. Preliminary clinical trials reveal that NorUDCA significantly outperformed placebo treatments, showcasing an excellent safety profile without reporting major adverse reactions.
Regulatory Approval
On August 14, 2025, India's Central Drugs Standard Control Organization (CDSCO) approved NorUDCA, marking a historic first in the realm of hepatology. Shilpa Medicare's Managing Director, Mr. Vishnukant Bhutada, called this approval a "transformational leap" for both the company and millions suffering from liver diseases. He expressed pride in being the first globally to offer this innovative treatment, underscoring a commitment to enhance healthcare solutions and broaden access to those in need.
Future Endeavors
Shilpa Medicare aims to expedite the commercialization of NorUDCA in India while also actively pursuing regulatory approvals in other countries, ensuring that this life-changing therapy can reach as many patients as possible. The company is renowned for its dedication to pharmaceutical innovation, specializing in Oncology and Non-Oncology API treatments, thus bolstering its efforts to provide effective healthcare solutions globally.
Conclusion
As Shilpa Medicare takes this giant leap into the future of liver health, NorUDCA emerges not just as a treatment but as a beacon of hope for numerous individuals worldwide. It represents the potential to change lives and alter the trajectory of NAFLD management, one patient at a time.
Topics Health）
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