FDA inspects and approves two French Novosep manufacturing sites
- In June, FDA inspected Novosep’s Chasse-sur-Rhone and Pompey manufacturing sites.
- Previously, FDA had inspected Novasep’s sites in Le Mans, Mourenx and Leverkusen. The inspections went well.
- After the latest inspections, Novasep is now cleared to produce an FDA-approved new molecular entity (NME).
One of the site inspections in June focused on ensuring that a multi-site project that Novosep manages for synthesizing and purifying a kinase inhibitor active ingredient was in line with Good Manufacturing Practices (GMP). Jean Claude Romain, VP of Quality at Novasep said, “Our teams at Novasep invest in and conduct continuous upgrades to ensure that ever stricter regulatory standards meet the highest level of compliance at all Novasep plants.”
- www.novasep.com Novasep passes FDA inspections on two sites