US FDA approves Novasep’s manufacturing sites in France after inspections
Novasep is a French company offering development services, contract manufacturing services and production of synthetic molecules and biomolecules. The company has facilities in Europe, Asia and North America, including Massachusetts, Pennsylvania and the Bahamas. Novasep successfully completed US FDA pre-approval inspections carried out at two of its sites in France.The FDA inspections took place during June 2014 at Novasep’s Chasse-sur-Rhone and Pompey sites in France. The Chasse-sur-Rhone site is responsible for the synthesis of late stage intermediates and the active pharmaceutical ingredient, while the Pompey site looks after the last purification step.These inspections permit the company to produce new molecular entities (NMEs) for the U.S market. Both the facilities are in line with Good Manufacturing Practices (GMP).The facilities are equipped for kinase inhibitor synthesizing and purifying.
In 2013, FDA had also inspected Novasep’s sites in Le Mans, Mourenx and Leverkusen. Novasep invests in and conducts continuous upgrades to ensure that ever stricter regulatory standards meet the highest level of compliance at all Novasep plants. Novasep also announced recently that it will be expanding its highly potent active pharmaceutical ingredients (HPAPI) plant in Le Mans to produce antibody drug conjugates (ADCs).