Active pharmaceutical ingredients (APIs) are produced in Syntagon’s state-of-the-art pilot plant with reactor capacities ranging from 20 to 800 liters. Clinical material is made under GMP (Good Manufacturing Process) in full compliance with ICH Q7 guidelines (link to ICH Q7a). Our pilot plant has five physically separated production suites, designed to operate under ISO 8 standards or better, that allow for simultaneous product campaigns.
For high-potency products, a dedicated facility equipped with state-of-the-art containment technology and air locks assures safe handling. Read more
about GMP manufacturing of high potency compounds.
Clinical API manufacturing
Pre-Clinical API manufacturing
QC and analytical services
Syntagon manufactures material for clinical and pre-clinical use. We are certified by the Swedish Medical Agency (EMEA) for manufacturing of clinical APIs and are regularly inspected by the Agency (2003, 2006, planned for 2009). Annually, we host ten to fifteen customer audits, to ensure continual compliance to the highest quality standards.