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Novasep gains approval from FDA to produce new molecular entity for US market.
Novasep has successfully completed FDA pre-approval inspections carried out at two of its sites in France. 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.
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 API, while the Pompey site takes charge of the last purification step.