Synopsis:
Shilpa Medicare received EMA’s initial nod for Rivaroxaban Orodispersible Films (10/15/20 mg), a generic version of Bayer AG’s innovator drug, Xarelto, enhancing geriatric care; approval from its Bengaluru Unit VI facility.
Shares of a company manufacturing niche APIs, intermediates, and formulations and also undertakes contract research and manufacturing service, hit a 5 percent upper circuit, after EMA granted initial authorisation for medicinal products in Europe, unlocking a $2.5 billion market opportunity.
With a market cap of Rs. 8,025 crores, the shares of Shilpa Medicare Limited hit a 5 percent upper circuit at Rs. 858.1 on BSE, as against its previous closing price of Rs. 817.25. The stock has delivered negative returns of around 4 percent in one year, and has fallen by about 3 percent in the last one month.
What’s the News
As per the latest exchange filings, Shilpa Medicare Limited has received the Initial Authorisation from the European Medicines Agency (EMA), recommending the grant of the final Marketing Authorisation for its medicinal product, Rivaroxaban Orodispersible Films (ODF) in 10 mg, 15 mg, and 20 mg strengths.
The application was submitted as a hybrid application under the EMA’s Centralized Procedure and represents a generic version of Bayer AG’s innovator drug, Xarelto, currently available in oral tablet form. Shilpa’s product has been demonstrated to be bioequivalent to Xarelto and is the first and only Rivaroxaban available in orodispersible film form, designed to improve patient comfort and compliance, particularly among geriatric patients.
Rivaroxaban ODF is an anticoagulant that helps prevent blood clot formation. It is prescribed for the treatment of deep vein thrombosis and pulmonary embolism, and for the prevention of their recurrence in adults. Additionally, it is indicated for the prevention of atherothrombotic events such as heart attack, stroke, or cardiovascular death in adults. The medicine works by selectively inhibiting Factor Xa, a key protein in the clotting process. The European market for oral Rivaroxaban formulations is estimated at around $2.5 billion, representing a significant commercial opportunity for the company.
This approval has been granted to Shilpa Medicare’s finished dosage form manufacturing facility (Unit VI) at Dabaspet, Bengaluru, Karnataka. The site is approved by leading global regulators, including the USFDA, EMA, and UK MHRA, and is engaged in manufacturing, packaging, labelling, and testing of specialised dosage forms such as orodispersible films and transdermal patches. Notably, this marks the third approval for a prescription oral mouth-dissolving film product in European markets from this facility.
Financials & More
Shilpa Medicare reported a significant growth in revenue from operations, experiencing a year-on-year increase of nearly 9.5 percent, from Rs. 293 crores in Q1 FY25 to Rs. 321 crores in Q1 FY26. Likewise, the company’s net profit increased during the same period from Rs. 14 crores to Rs. 47 crores, representing an impressive rise of nearly 236 percent YoY.
Shilpa Medicare Limited, a prominent player in the global pharmaceutical industry and one of the world’s leading suppliers of oncology/non-oncology APIs and intermediates, is engaged in the business of manufacturing API, formulation and development services.
The company is presently dealing in high-quality Active Pharmaceutical Ingredients (APIs), intermediates, formulations, new drug delivery systems, peptides/biotech products and specialty chemicals, etc., using sophisticated technology meticulously in order to comply with laid down international standards/ specifications.
Written by Shivani Singh
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