#India #NASH #Shilpa Medicare #Raichur #Nor UDCA

Shilpa Medicare's Groundbreaking NASH Treatment

Shilpa Medicare Limited, a prominent manufacturer in the pharmaceutical sector, has recently made headlines by securing approval from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) for its Investigational New Drug (IND): Nor-Ursodeoxycholic Acid (Nor UDCA) tablets. This innovative drug, particularly in 500 mg dosages, is targeted for treating non-alcoholic fatty liver disease (NAFLD), a condition affecting approximately 1.2 billion individuals globally, including a staggering 188 million Indians.

Understanding Non-Alcoholic Fatty Liver Disease

NAFLD is recognized as the most widespread liver disease, and without intervention, it can lead to a more severe condition known as non-alcoholic steatohepatitis (NASH). NASH is associated with significant health risks, including liver damage and liver failure. As the prevalence of NAFLD continues to rise, Shilpa Medicare’s approval signifies a hopeful breakthrough in patient treatment options.

Shilpa Medicare's clinical journey for Nor UDCA has involved rigorous phase-3 trials, targeting the safety and efficacy of the drug. The results from this study—a randomized, double-blind, placebo-controlled, multicenter trial—exhibited compelling outcomes. The research focused on assessing whether participants suffering from NAFLD could experience significant improvements in liver conditions following treatment with Nor UDCA.

Remarkable Clinical Results

The findings revealed astonishing advancements:
1. Liver Fibrosis Reversal: An impressive 83.3% of the participants showcased a reversal in fibrosis, indicating substantial healing in liver tissue, while the remaining individuals experienced stabilization.
2. ALT Levels Normalization: Approximately 90% of participants showed normalized alanine transaminase (ALT) levels, a crucial indicator used to evaluate liver health, within just 12 weeks of treatment.

These results not only demonstrate Nor UDCA's promise as a therapeutic option but also highlight its advantages compared to traditional Ursodeoxycholic Acid (UDCA), which includes enhanced choleretic effects, less susceptibility to amidation, anti-inflammatory properties, and reduced fibrosis.

Future Prospects and Strategic Plans

Mr. Vishnukant Bhutada, the Managing Director of Shilpa Medicare, expressed excitement following the SEC's approval. He stated, “This approval represents an important step forward in addressing unmet medical needs for a considerable patient population. We are committed to liaising closely with regulatory authorities to expedite the launch of this innovative treatment in India by the next fiscal year.”

Shilpa’s commitment to addressing healthcare challenges demonstrates their mission of ‘Innovating for affordable healthcare’ and aims to reach out to global regulatory bodies to explore international market opportunities for Nor UDCA.

Founded in 1987, Shilpa Medicare offers a diverse range of active pharmaceutical ingredients (APIs), formulations, and biologics, with facilities that meet stringent regulations. They are also recognized for providing complete turnkey Contract Development and Manufacturing Organization (CDMO) solutions worldwide. With this recent breakthrough, Shilpa Medicare is poised to impact the treatment landscape for liver diseases positively, providing hope to millions who suffer from NAFLD and NASH.

For more inquiries about this groundbreaking development, you can contact Shilpa Medicare directly at their official email.