This application, submitted as a hybrid application via the EMA’s Centralized Procedure, is a generic version of the innovator product Xarelto, from Bayer AG, which is available as oral tablets. Shilpa Medicare’s product is bioequivalent to the reference product Xarelto and is the only Rivaroxaban in ODF form which can help in patient comfort, especially in geriatric patients.
Rivaroxaban Orodispersible Films is an anticoagulant medicine (a medicine that prevents blood clotting). It is used to treat deep vein thrombosis and pulmonary embolism, and to prevent their recurrence in adults. It is also used to prevent atherothrombotic events (such as heart attack, stroke or death from heart disease) in adults. It works by inhibiting a highly selective, direct factor Xa.
The total Europe market for oral Rivaroxaban formulations is about $2.5 billion.
This approval has come from the company’s finished dosage form manufacturing facility, Shilpa Medicare, Unit VI, located at Dabaspet, Bengaluru, Karnataka. The facility is currently approved by USFDA, Europe and MHRA UK. This is the third approval of a prescription oral mouth dissolving film product in the European markets from this facility. The facility is involved in manufacturing, packaging, labelling and testing of specialized finished dosage forms as oral dispersible/dissolving films and transdermal patches.
Shilpa Medicare is a manufacturer of API, formulation, and development services. The company's consolidated net profit surged to Rs 46.89 crore in the quarter ended June 2025 as against Rs 14.06 crore during the previous quarter ended June 2024. Sales rose 9.90% to Rs 321.46 crore in Q1 FY26 as compared with Q1 FY25.