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Three sites in France and Germany pass U.S. FDA inspection
December 20, 2016
By: Kristin Brooks
Managing Editor, Contract Pharma
Novasep’s custom manufacturing sites in France (Mourenx and Le Mans), and Germany (Leverkusen) have passed U.S. FDA inspection, with no 483 form. Novasep’s manufacturing site in Le Mans, France, produces highly potent cytotoxic active pharmaceutical ingredients (HPAPI) and registered advanced intermediates for commercial and clinical development. The site also provides regulatory and containment evaluation support. It produces paclitaxel, for which Novasep holds a valid Drug Master File an...
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