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 and a European CEP (Certificate of Suitability). The site is also provides Antibody Drug Conjugate (ADC) payload production services that will soon be extended to ADC conjugation. The manufacturing site in Mourenx, France, produces APIs and advanced intermediates.
 
Novasep’s site in Leverkusen, Germany handles hazardous chemicals at industrial scale. The company’s technical expertise at the site is particularly suitable for designing shorter, cost-effective synthetic routes for producing APIs and advanced intermediates. 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 U.S.
 
“This success has been made possible by the day-to-day good practices adopted by every colleague involved in operations. The robust system implemented by Novasep’s quality assurance team ensures these high standards,” said Jean-Claude Romain, vice president of quality at Novasep. “These three successful inspections reward this long-term teamwork and commitment.”