EDQM suspends five API certificates

The European Directorate for the Quality of Medicines & Healthcare (EDQM) suspended five certificates of suitability (CEPs) for active pharmaceutical ingredients after inspections of manufacturing sites in October and November.

A CEP is a document - cited by drugmakers using APIs in their medicinal products - which certifies the ingredients comply with agreed quality standards.

The latest crop of suspensions were for: JP Laboratories' diluted isosorbide mononitrate (CEP-2002-104); Biochem Corp's protamine sulfate (CEP-2000-162); and oxytetracycline hydrochloride made by and Huashu Pharmaceutical Corp (CEPs 2002-211 and 2002-070) and Hanmi Fine Chemical Co (CEP-2002-155).

In November, the EDQM carried out one inspection - bringing its tally for the year to 19 - and received 34 new CEP applications, of which 25 were granted.