Shilpa Medicare Share Price Hit 5% Upper Circuit on EMA Nod for Rivaroxaban ODF

On September 23, 2025, Shilpa Medicare share price (NSE: SHILPAMED) hit the 5% upper circuit at ₹858.10 before settling 2.04% higher at ₹833.95. In contrast, the BSE Sensex traded flat at around 82,149.

What Sparked the Rally

The rally came after Shilpa Medicare announced it received Initial Authorisation from the European Medicines Agency (EMA) for its Rivaroxaban Orodispersible Films (ODF) in 10 mg, 15 mg, and 20 mg strengths. This paves the way for final marketing approval in Europe.

About the Product

Rivaroxaban is a blood thinner used to prevent clots, treat deep vein thrombosis and pulmonary embolism, and reduce risk of stroke and heart attack.

Shilpa’s version, developed as an orodispersible film (ODF), is bioequivalent to Bayer’s Xarelto and is designed for easier use, especially for elderly patients.

Market Opportunity

The European market for oral Rivaroxaban formulations is worth an estimated $2.5 billion. Shilpa’s ODF will be made at its Unit VI facility in Karnataka, already approved by the USFDA, EMA, and UK’s MHRA. This is also Shilpa’s third ODF approval in Europe.

Shilpa Medicare Financial Highlights

In Q1 FY26, Shilpa Medicare reported a net profit of ₹46.8 crore, up from ₹14 crore in Q1FY25. Revenue rose 9.9% YoY to ₹321.5 crore, while EBITDA grew 25% to ₹91.7 crore. Margins improved to 28.5% from 25%.

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About Shilpa Medicare

Shilpa Medicare is a global pharma player focused on APIs and formulations, especially in oncology. It operates in regulated markets like the US, Europe, and Japan, and also offers CDMO services. The company has a market cap of ₹8,155 crore and is part of the BSE SmallCap index.

Conclusion

Shilpa Medicare’s EMA approval for Rivaroxaban ODF boosted investor confidence, driving the stock to its upper circuit. With a strong product pipeline, robust financials, and growing presence in regulated markets, the company is well-positioned for future growth.

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