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Amarin released the submission of an sNDA to FDA seeking approval for Novasep Group.
Amarin, a biopharmaceutical company, has filed a supplemental new drug application with FDA seeking approval to make Novasep Group, through its subsidiary Finorga, as an additional supplier of icosapent ethyl, the API in Vaseepa Amarin’s omega-3-fatty acid product supplier. Novasep is part of the previously disclosed Slanmhor consortium with which Amarin announced a global supply agreement in 2012.
Novasep, a provider of purification technologies and API manufacturing, is building a chromatography plant using its proprietary chromatography technologies to produce API on behalf of the Slanmhor consortium and Amarin. Amarin anticipates the Novasep facility, located in Mourenx, France, to be qualified and operational for manufacturing in 2014.