The mission
« One of our Customers was the holder of an innovative product for which it had obtained an NDA (New Drug Application) in the United States. We were already making the active ingredient for this Customer who was very satisfied with the quality. The Customer asked us to increase the API's level of solubility. »
« To do this, we selected one of the two polymorphic forms this active ingredient could be in and monitored the particle size distribution of the powder. The form sought by our Customer was particularly difficult to obtain! These changes allowed our Customer to patent our innovation. It also involved a new authorization request from US health authorities to validate the changes and the new synthetic route. Seratec's laboratory is inspected by the FDA, so we were able to meet the regulatory requirements. »