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Shilpa Medicare gets initial authorization from EMA for Rivaroxaban Orodispersible Films

Bengaluru: Shilpa Medicare Limited, headquartered at Raichur, Karnataka, India, has received the initial authorization from European Medicine Agency (EMA), recommending the grant of the final Marketing Authorization for the company’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 a 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 USD 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.
Shilpa Medicare is a global pharmaceutical company specializing in contract development and manufacturing services for small and large molecules. With a strong emphasis on oncology and a growing presence in biologics, the company offers comprehensive solutions from discovery to commercial supply. Shilpa Medicare operates R&D and manufacturing facilities, serving partners across North America, Europe, and Asia.
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751