Shilpa Medicare Limited has received initial authorization from the European Medicines Agency (EMA) for its Rivaroxaban Orodispersible Films (ODF), a generic alternative to Bayer AG’s blockbuster anticoagulant, Xarelto®. The approval covers 10 mg, 15 mg, and 20 mg strengths, paving the way for final marketing authorization in Europe.
Unlike the reference product, Shilpa’s ODF formulation is designed to enhance patient comfort, particularly for elderly users who may face difficulties swallowing traditional oral tablets. This patient-centric innovation underscores Shilpa’s commitment to novel drug delivery platforms.
Market Opportunity and Scope
Rivaroxaban is widely prescribed for the prevention and treatment of deep vein thrombosis, pulmonary embolism, and thromboembolic events such as stroke and heart attack. The European market for oral Rivaroxaban formulations is valued at approximately USD 2.5 billion annually, offering significant commercial potential for Shilpa’s differentiated ODF product.
The EMA approval pertains to Shilpa’s Unit VI facility at Dabaspet, Bengaluru—a site already accredited by the USFDA, EMA, and the UK’s MHRA. The unit specializes in advanced dosage technologies such as oral dissolving films and transdermal patches. This marks the third European approval for ODF-based prescription products from the same facility, reinforcing its credibility as a hub for innovative drug delivery systems.
Financial Performance
Shilpa Medicare reported robust earnings growth in Q1 FY26, with net profit surging to ₹46.8 crore from ₹14 crore a year earlier. Revenues rose 9.9% year-on-year to ₹321.5 crore, while EBITDA jumped 25% to ₹91.7 crore. The company’s EBITDA margin improved to 28.5% from 25% in the same period last year, reflecting operational efficiency and scale benefits.
Company Profile
Founded in 1987 and headquartered in Raichur, Karnataka, Shilpa Medicare is a diversified pharmaceutical player engaged in specialty formulations, oncology drugs, APIs, and contract development and manufacturing services (CDMO). The company operates globally across regulated markets including the US, Europe, and Japan. With a market capitalization of ₹8,155 crore, it is a constituent of the BSE SmallCap index and the Nifty Total Market Index.
Summary
Shilpa Medicare’s EMA nod for Rivaroxaban ODF not only strengthens its European footprint but also highlights its capabilities in differentiated drug delivery technologies. With a large $2.5 billion addressable market, improving financials, and growing regulatory approvals, the company is well-positioned to scale its presence in high-value global markets while offering patient-friendly alternatives to established therapies.
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