Shilpa Medicare Limited , a prominent player in the pharmaceutical industry, has achieved a significant milestone with its drug Norduca (NorUDCA) receiving approval as the world's first therapy for Non-Alcoholic Fatty Liver Disease (NAFLD). This groundbreaking development marks a pivotal moment in addressing a major liver condition that affects millions globally.

A Pioneering Achievement

Norduca, developed by Shilpa Medicare, has secured approval as India's first-in-class therapy for NAFLD. This achievement positions Shilpa Medicare as the first company worldwide to obtain regulatory approval for an NAFLD-specific treatment, addressing an unmet medical need in liver health.

Market Impact and Future Plans

The company plans to launch Norduca tablets in the Indian market, with revenue generation expected to commence from the third quarter of the fiscal year 2026. Shilpa Medicare is also advancing its global regulatory efforts to make this vital therapy available to patients internationally, potentially opening up significant market opportunities.

Strategic Implications

This approval represents a major leap forward for Shilpa Medicare in the pharmaceutical landscape. It not only demonstrates the company's research and development capabilities but also positions it as a pioneer in liver disease treatment. The successful development and approval of Norduca could potentially lead to increased investor confidence and market share in the growing field of liver therapeutics.

Financial Outlook

While specific financial projections related to Norduca were not disclosed, the approval is likely to have a positive impact on Shilpa Medicare's future revenue streams. The company's recent financial performance shows promise, with the first quarter of fiscal year 2026 reporting:

Corporate Developments

In addition to this significant drug approval, Shilpa Medicare has announced several corporate actions:

1. A 1:1 bonus share issue, subject to shareholder approval at the upcoming Annual General Meeting (AGM)
2. The record date for the bonus shares is set for September 26, 2025
3. The 38th AGM is scheduled for September 23, 2025, to be held virtually

Conclusion

The approval of Norduca as the first global therapy for NAFLD represents a landmark achievement for Shilpa Medicare. It underscores the company's commitment to innovation in addressing critical health challenges and positions it for potential growth in the liver disease treatment market. As Shilpa Medicare moves forward with the launch of Norduca in India and pursues global regulatory approvals, the pharmaceutical industry will be watching closely to see how this pioneering treatment impacts the landscape of liver disease management.

Shilpa Medicare Limited , a leading pharmaceutical company, has announced a series of significant decisions in its recent board meeting, including a 1:1 bonus share issue, robust financial results for the first quarter of fiscal year 2026, and key record dates for shareholders.

Bonus Share Issue and Record Dates

The board has approved the issuance of bonus shares in the ratio of 1:1, effectively doubling the company's paid-up capital. The record date for determining shareholder eligibility for bonus shares is set for September 26, 2025. Under this bonus issue, shareholders will receive one new equity share for every existing equity share held.

Additionally, Shilpa Medicare has set September 17, 2025 as the record date for determining shareholder eligibility for the final dividend for financial year 2024-25, subject to approval at the Annual General Meeting scheduled for September 23, 2025. The dividend will be paid within the statutory time limit if approved by shareholders at the AGM.

Q1 FY26 Financial Highlights

Shilpa Medicare reported strong financial performance for the quarter ended June 30, 2025:

The company achieved its highest quarterly EBITDA of Rs. 98.00 crore, with EBITDA margins expanding to 30.00%. The revenue growth was primarily driven by the API and Biologics verticals.

Board Changes and Reappointments

Several key board changes were announced:

• Mr. Om Prakash Inani was reappointed as Chairman.
• Mr. Sharath Reddy Kalakota was reappointed as Whole Time Director for 5 years.
• Mr. Ashraf Loutfy Abdelhamid Allam was appointed as Additional Independent Director for 2 years, replacing Dr. Kamal Kishore Sharma.
• Dr. Anita Bandyopadhyay was reappointed as Women Independent Director for 3 years.

Other Key Decisions

• The 38th Annual General Meeting is scheduled for September 23, 2025, to be held via video conferencing.
• The board recommended reclassification of Mr. Suraj Kumar Inani and Ms. Priya Inani from the promoter group to public category, subject to necessary approvals.
• The company's material subsidiary, Shilpa Pharma Lifesciences Limited, fully redeemed its outstanding Non-Convertible Debentures on August 11, 2025.

Management Commentary

Mr. Vishnukant Bhutada, Managing Director, commented on the results: "The first quarter of FY26 demonstrated steady progress and strong execution of our strategic priorities. Our partner successfully launched our second NDA in the U.S.—Bortezomib RTU—reinforcing our R&D-driven approach. We achieved a historic milestone with NorUDCA's approval, making Shilpa Medicare the first global company approved for NAFLD treatment."

He added, "Our API division reported growth of approximately 25% YoY. In Biologics, our strategic investment in Alveolus Bio accelerates innovation and solidifies Shilpa Medicare's position as a global biotech enabler."

With these developments, Shilpa Medicare continues to strengthen its position in the pharmaceutical industry, focusing on innovation, strategic partnerships, and operational excellence.