Asian API makers run afoul of EU regulator

The European Directorate for the Quality of Medicines suspended more than two dozen certificates of suitability (CEPs) held by API makers in 2010 because manufacturers failed or refused inspections. All but one of the manufacturers is located in Asia.

Nine of the affected CEPs are assigned to six Chinese companies, while two Indian firms account for another six, reports SecuringPharma. Two were from a Korean supplier and one involved a Thai company. One, from a Northern Ireland manufacturer, has been reinstated.

EDQM prohibits drugmakers from using the APIs of the named suppliers.

The regulator awards the certificates, which permit the supplier to sell its products in the EU, once the manufacturer states that its operations comply with good manufacturing practices. The EDQM conducts periodic inspections to verify compliance. 

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