Novasep Synthesis at Chasse/Rhône is providing active pharmaceutical ingredients or advanced intermediates to the pharmaceutical industry. This involvement guarantees the efficiency of our Quality Assurance system and that our products are manufactured to the highest standards, meeting regulatory and customer requirements. |
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A number of regulatory files are handled by our Regulatory Affairs team. DMFs have been registered with the different regulatory authorities in Europe, the USA, Canada etc. for most of the APIs produced by Finorga.
The site has been successfully inspected several times by the US FDA since 1986 in addition to local AFSSAPS (Agence Française de Sécurité Sanitaire des Produits de Santé) inspections.
It was last inspected by the FDA in November 2003 and by the AFSSAPS in September 2004.
Compliance with regulatory requirements is also assessed during the numerous customer and internal audits carried out at the sites of Chasse-sur-Rhône and Mourenx.