Shilpa Medicare Wins SEC-CDSCO Approval for Nor-Ursodeoxycholic Acid Tablets Against NASH

Shilpa Medicare Secures SEC-CDSCO Nod for Nor-Ursodeoxycholic Acid Tablets

Shilpa Medicare Limited, a prominent player in the API and formulation industry, has recently achieved a significant milestone. The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has granted approval for its Investigational New Drug (IND) application for Nor-Ursodeoxycholic Acid (Nor UDCA) tablets, aiming to address the growing issue of non-alcoholic fatty liver disease (NAFLD).

This approval comes at a crucial time, as NAFLD is now considered the most prevalent liver disease worldwide, affecting approximately 25% of the global population, which equates to around 1.2 billion individuals. In India alone, there are roughly 188 million reported cases. If left untreated, NAFLD can advance to non-alcoholic steatohepatitis (NASH), a serious liver condition that can lead to significant health complications or even mortality.

Shilpa Medicare has previously completed Phase-3 clinical trials for its Nor UDCA tablets and presented the results to the SEC. The study, a Phase-III, randomized, double-blind, placebo-controlled trial, was conducted to assess the safety and effectiveness of this innovative treatment on patients suffering from NAFLD. The trial met all primary efficacy endpoints, showcasing a noteworthy improvement in the fatty liver stage among participants.

One of the key findings revealed that 83.3% of the trial participants experienced liver fibrosis reversal, with the remaining participants showing stabilization in their condition. Furthermore, the study found that approximately 90% of participants normalized their elevated alanine transaminase (ALT) levels—an important biomarker for NAFLD—within just 12 weeks of treatment.

The results from the clinical trials indicate that Nor UDCA presents a groundbreaking advancement in the treatment of NAFLD, offering numerous advantages over conventional therapies, including a better choleretic effect, resistance to amidation, anti-inflammatory properties, and a reduction in fibrosis.

In response to this critical development, Mr. Vishnukant Bhutada, Managing Director of Shilpa Medicare Limited, expressed his satisfaction, stating, "We are very pleased with this approval from SEC and hope to get the marketing approval soon. We are committed to working closely with regulatory authorities to bring this innovative treatment to patients as quickly as possible and are hopeful of launching it in India in the coming financial year. This NCE molecule approval exemplifies the true spirit of Shilpa, 'Innovating for affordable healthcare', keeping in mind the unmet needs of a large patient pool. Based on the approval in India, we plan to reach out to global regulatory authorities to seek scientific advice for introduction of this novel product internationally."

Shilpa Medicare, established in 1987, is recognized for its diverse portfolio that includes APIs, formulations, and biologics, and boasts manufacturing facilities that are compliant with major regulatory standards worldwide. The company also offers comprehensive turnkey CDMO solutions for a global clientele, further solidifying its position in the pharmaceutical sector.

As a rising leader, Shilpa Medicare is set to make a transformative impact on healthcare with the anticipated launch of Nor UDCA. This innovative treatment not only aligns with the company’s mission to provide affordable healthcare solutions but also addresses a significant unmet need among patients suffering from NAFLD. The focus on global outreach signals Shilpa's ambition to play a crucial role in the international pharmaceutical landscape.

For more information and inquiries, you can reach out to Shilpa Medicare’s communication team at their official website.