Shilpa Medicare has achieved a significant regulatory milestone with the approval of its Rotigotine transdermal patch in Europe. This marks the company's first approval for this specialized neurological treatment product in the European market, opening new avenues for growth in the pharmaceutical sector.

Product Details and Market Opportunity

The Rotigotine transdermal patch represents a sophisticated drug delivery system designed for neurological applications. Shilpa Medicare has identified substantial market potential for this product, with estimates indicating a total addressable market of approximately USD 222 million.

Launch Timeline and Strategic Positioning

Shilpa Medicare plans to launch the Rotigotine transdermal patch by FY27. This timeline allows the company to prepare its manufacturing capabilities, establish distribution networks, and ensure compliance with European regulatory requirements.

The transdermal patch technology offers several advantages in drug delivery, particularly for neurological conditions where consistent medication levels are crucial for patient outcomes. This approval positions Shilpa Medicare to compete in the specialized pharmaceutical segment focused on advanced drug delivery systems.

Market Impact and Growth Prospects

The European approval represents a strategic expansion for Shilpa Medicare into high-value pharmaceutical products. The USD 222 million market potential indicates significant revenue opportunities for the company as it establishes its presence in the European neurological treatment market.

This regulatory success demonstrates the company's capability to develop and gain approval for complex pharmaceutical products that meet stringent European standards. The achievement could serve as a foundation for future product approvals and market expansion initiatives in the region.

Shilpa Medicare Limited , a leading pharmaceutical company, has reported its strongest quarterly performance to date in Q2 FY26, with record-breaking revenues and EBITDA. The company also announced the launch of its first Novel Chemical Entity (NCE) product in India, marking a significant milestone in its growth trajectory.

Financial Highlights

Shilpa Medicare achieved its highest quarterly revenues of INR 372.00 crores in Q2 FY26, representing a 7% year-over-year growth. The company's EBITDA crossed the INR 100 crores milestone for the first time, reaching INR 110.00 crores with a 30% EBITDA margin and 21% growth compared to the same quarter last year.

For the first half of FY26, Shilpa Medicare reported:

Launch of First NCE Product

In a significant development, Shilpa Medicare has launched its first Novel Chemical Entity (NCE) product, NorUrsodeoxycholic Acid (NorUDCA), in India. This launch positions Shilpa Medicare as the first company globally to bring this product to market in India. NorUDCA is targeted at treating Non-Alcoholic Fatty Liver Disease (NAFLD), a condition with a high prevalence in India.

Business Segment Performance

API Business

• The non-captive API business reported a turnover of INR 205.00 crores in Q2 FY26.
• The company is developing two NCE programs for a major pharmaceutical customer, with commercial supplies for the first product expected to start from Q4 FY26.
• Shilpa Medicare is expanding its Tranexamic Acid capacity by an additional 100 metric tons, with the new capacity expected to be commissioned in the next financial year.

Formulation Business

• The Formulation business grew by 16% year-on-year, reaching INR 109.00 crores in Q2 FY26.
• Excluding licensing income, the base business reported a robust growth of about 60% for the quarter and 67% for the first half of FY26.
• The growth was driven by increasing market share of complex product portfolio in the U.S. and limited competition products in the EU market.

Biologics Business

• The Biologics segment recorded revenue of INR 25.00 crores in Q2 and INR 61.00 crores in H1 FY26.
• The company has 8 biosimilar programs in various stages of development, including Aflibercept, which is currently under Phase III studies.

Future Outlook

Shilpa Medicare expects commercial supplies from multiple pipeline products, including NCE programs, Semaglutide, and biosimilars, to drive future growth across API, formulations, and biologics segments. The company is also investing in new capacities, including a dedicated peptide facility and expansion of its Albumin production capabilities.

With a strong pipeline of complex formulation products and biosimilars, Shilpa Medicare is well-positioned for sustained growth in the coming years. The company's focus on complex generics, differentiated products, and strategic partnerships is expected to enhance its market position in both domestic and international markets.