Following an inspection by the Finnish Medicine Agency the manufacturing site Taishan City Chemical Pharmaceutical CO. LTD - China resulted as non compliant with the GMPs. Therefore the EDQM withdrew their certificate R0-CEP 2006-223-Rev 01/Cyclosporine.
AIFA Assessment and Authorization Office required all MAHs of medicinal product containing this active substance to urgently check whether this site results as starting material/intermediate/active substance supplier and to send prompt communication to the Agency. MAHs which authorized this site as supplier will have to submit a variation within September 22nd to replace it with another GMP-compliant site.
In case of no communication, AIFA will withdraw the products. The communication should be sent also in case of negative feedback.
