Novasep has successfully completed pre-approval inspections conducted by the US Food and Drug Administration 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, and the Pompey site is responsible for the last purification step.

With the successful inspections, Novasep is now an authorized producer of a new molecular entity already approved in the US. The inspection concerned a multi-site project Novasep manages for synthesizing and purifying a kinase inhibitor active ingredient.

Source: Novasep