Shilpa Medicare secures EU approval for Rivaroxaban films

Shilpa Medicare Limited has received Initial Authorization from the European Medicine Agency (EMA) for its Rivaroxaban Orodispersible Films in 10 mg, 15 mg, and 20 mg strengths. This approval, announced on September 22, 2025, allows Shilpa Medicare to market a bioequivalent generic version of Bayer AG’s Xarelto® in ODF form, catering to patient comfort, particularly in geriatric populations.

Rivaroxaban Orodispersible Films, an anticoagulant, are used to treat and prevent deep vein thrombosis, pulmonary embolism, and atherothrombotic events, inhibiting direct factor Xa. The European market for oral Rivaroxaban formulations is estimated at about $2.5 bn.

This marks the third European approval for a prescription oral mouth dissolving film product manufactured at Shilpa Medicare’s Dabaspet, Bengaluru facility. The facility is also approved by USFDA, Europe, and MHRA UK, specializing in manufacturing, packaging, labeling, and testing of various finished dosage forms.