Shilpa Medicare receives initial authorization for Rivaroxaban Orodispersible films from EMA

Shilpa Medicare Limited  has received the initial authorization from European Medicine Agency (EMA), recommending the grant of the final Marketing Authorization for Shilpa Medicare's medicinal product, Rivaroxaban 10 mg, 15 mg, and 20 mg Orodispersible Films.

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'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.

Shilpa's 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 US$ 2.5 billion.

This approval has come from the company's finished dosage form manufacturing facility, Shilpa Medicare Ltd, 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.