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Novasep’s three facilities located in France and Germany are free of Form 483.
On Dec. 20, 2016, Novasep announced that three of the company’s manufacturing facilities have passed FDA general inspection process and are free of Form 483. The inspections took place at Novasep’s manufacturing sites in Mourenx and Le Mans, France, and Leverkusen, Germany.
The Le Mans site produces highly potent cytotoxic active pharmaceutical ingredients (HPAPI) and registered advanced intermediates for commercial or clinical development use. The site also provides customers with regulatory and containment evaluation support. It produces paclitaxel, for which Novasep holds a valid drug master file and a European certificate of suitability. The site also offers antibody drug conjugate (ADC) payload production services that will soon be extended to ADC conjugation. Novasep’s site in Leverkusen, Germany handles hazardous chemicals at industrial scale. The site also produces and sells pre-formulated nitroglycerin products for the pharmaceutical market. In each case, the FDA inspection confirmed that commercial APIs produced at each site are suitable for drugs marketed in the United States.