Shilpa Medicare Secures EMA Nod for Rivaroxaban Orodispersible Films

Shilpa Medicare Limited has obtained initial authorization from the European Medicines Agency (EMA) for its Rivaroxaban Orodispersible Films, a generic alternative to Bayer AG’s Xarelto®. Developed to enhance patient comfort—particularly for elderly patients—the formulation has been proven bioequivalent to the reference drug and is indicated for the treatment and prevention of multiple thrombotic conditions.

The company noted that this approval “strengthens Shilpa’s position in the European market,” where the oral Rivaroxaban segment is valued at nearly USD 2.5 billion. It also marks the third prescription oral mouth-dissolving film product to be cleared from Shilpa’s Bengaluru facility.