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. 

- see the article (includes list)


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.