Our Quality Management System ensures high product quality, manufacturing in compliance with all guidelines and regulations related to Good Manufacturing Practices (cGMP) - such as Eudralex Volume 4 Part II for Active Substances, ICH Q7 GMP for API's and CFR 210/211 cMGP - and Safety, Health & Environment (SHE). Our Quality Control laboratories form an integral part of our cGMP manufacturing network. With the stringent controls for chemical starting materials, in-process controls and the extensive characterization of final products, we can ensure the right quality API, manufactured in compliance with the relevant regulations and its regulatory dossier (US-DMF, ASMF, CEP, J-DMF, etc.).
All manufacturing facilities are regularly inspected and approved by international health authorities such as the Food & Drug Administration (US FDA), the European Medicines Agency (through the Governmental Healthcare Inspectorate, IGZ, in The Netherlands) and the Pharmaceuticals and Medical Devices Agency (PMDA, Japan), as well as by customers' audits.
Our products are generally released according to internationally accepted pharmacopeias (EP, USP, JP, etc.) and, at the request of our customers, in accordance with individual customer specifications.