Shilpa Medicare Receives EMA Nod for Rivaroxaban Films

Shilpa Medicare Limited from instance, Raichur, Karnataka has been approved by the European Medicines Agency (EMA) to start selling its Rivaroxaban 10 mg, 15 mg, and 20 mg Orodispersible Films (ODF) with the final marketing authorization.

This product is submitted by a hybrid application through a centralized procedure of EMA and is a generic version of the innovator drug Xarelto by Bayer AG, which is available as oral tablets. Rivaroxaban ODF made by Shilpa is of the same standard as the original and is especially convenient for elderly patients with swallowing problems, in normal, it is hard to give the medicine in form of tablets.

In most cases, Rivaroxaban acts as a blood thinner to stop the formation of blood clots and is the first-line treatment for deep vein thrombosis (DVT), pulmonary embolism (PE), and the prevention of atherothrombotic events that may consist of heart attacks, strokes, and cardiovascular mortality. The market for oral Rivaroxaban in Europe is approx. $2.5 billion per year.

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The approved Shilpa Medicare’s Unit VI facility in Dabaspet, Bengaluru, has already got the green light from the USFDA, EMA, and MHRA (UK). This permission is the third for manufacturing prescription oral mouth-dissolving film products at this site. Unit VI is the injection point for the production, packaging, labeling, and testing of special dosage forms, even orodispersible films and transdermal patches are included.

Shilpa Medicare is a worldwide pharmaceutical company with extensive knowledge of contract development and manufacturing services (CDMO) for small and large molecules, with a major concentration on oncology and biologics. The company offers complete solutions from drug discovery to commercial supply, catering to the needs of partners located in North America, Europe, and Asia.