DOTTIKON EXCLUSIVE SYNTHESIS is authorized by Swissmedic (Swiss Agency for Therapeutic Products) to manufacture and sell active pharmaceutical ingredients (APIs) including liquid and solid dosage forms based on regular inspections by the Regional Medicines Inspectorate of North-Western Switzerland.
The most recent audit was satisfactorily completed in July 2011. This as well as DOTTIKON ES' most recent audit by the US FDA, which was satisfactorily completed in September 2012 demonstrates that DOTTIKON ES is well in compliance with the current GMP regulations according to ICH Q7 (Eudralex, Vol. 4, Part II, PIC/S PE 009, Part II) as well as 21 CFR.
Compliance with cGMP is ensured by DOTTIKON ES' Quality Management System. DOTTIKON ES has integrated current Good Manufacturing Practice (cGMP) as an integral component into their Quality System according to ISO 9001:2008. Qualification of equipment and validation of processes is an essential part of that system.
DOTTIKON ES is committed also in future to the high established cGMP quality standard. We do our utmost to develop this standard further in order to continue serving our customers as an approved supplier of products manufactured under cGMP requirements.