Shilpa Medicare Gains EMA Nod for Rivaroxaban Orodispersible Films, Stock Jumps 1.8%

Mumbai, September 23, 2025: Shilpa Medicare Limited (BSE: 530549, NSE: SHILPAMED) jumped 1.85% to ₹833 at 2:10 PM, after the firm said it has gained initial authorization from the European Medicines Agency (EMA) for Rivaroxaban Orodispersible Films (ODF).

The EMA has approved the granting of final marketing authorization for Shilpa’s 10 mg, 15 mg, and 20 mg ODF formulations, which are formulated as a generic form of Bayer AG’s blockbuster anticoagulant medicine Xarelto®. The ODF formulation of Shilpa, unlike that of the reference product, is intended to provide greater patient comfort, particularly for elderly use.

Established in 1987 and having its headquarters in Raichur, Karnataka, Shilpa Medicare Limited is a listed pharma firm involved in the manufacture of specialty formulations, oncology drugs, and new delivery systems. It is a constituent of the Nifty Total Market Index and is globally operational with approvals of top regulators.

Market Potential and Product Scope

Rivaroxaban is extensively used for the prevention and treatment of diseases like deep vein thrombosis, pulmonary embolism, and atherothrombotic events like strokes and heart attacks. The overall European market for oral formulations of Rivaroxaban is estimated at USD 2.5 billion per annum.

The approval has been obtained for the manufacture in Shilpa Medicare’s Unit VI facility at Dabaspet, Bengaluru, which is already approved by the USFDA, EMA, and MHRA UK. The unit specializes in innovative dosage forms, such as oral dissolving films and transdermal patches. It is the third European ODF prescription approval from the unit.

Share Price Update

Shilpa Medicare’s stock price was trading at ₹833.60, an appreciation of 1.85% on September 23, 2025, at 2:10 PM. Shilpa Medicare Ltd started the day’s trading at ₹825.00, with the day’s high and low being ₹859.35 and ₹824.80, respectively. The company’s market capitalization stands at ₹8,150 crore.

Its P/E ratio is 73.25. It provides a relatively modest dividend yield of 0.12%, with a quarterly dividend of ₹0.25 per share. Its price has fluctuated between ₹555.00 and ₹1,000.00 over the last year, bringing its 52-week low and high into focus.

REF: https://nsearchives.nseindia.com/corporate/SHILPAMED_22092025230518_SEintimation220925.pdf

Disclaimer: At HDFC SKY, we take utmost care and due diligence in curating and presenting news and market-related content. However, inadvertent errors or omissions may occasionally occur.

If you have any concerns, questions, or wish to point out any discrepancies in our content, please feel free to write to us at content@hdfcsec.com.

Please note that the information shared is intended solely for informational purposes and does not make any investment recommendations