Further CEPs from Chinese and Indian Manufacturers suspended or withdrawn

In addition to the previously published suspension of 5 CEPs (see GMP News from 29 April 2009) the European Directorate for the Quality of Medicines and HealthCare (EDQM) announced further actions on CEP holders.

The EDQM announces the suspension of the following CEPs as failure to commitments of willingness to be inspected (refusal of inspection, reconstruction/restoration of sites to achieve GMP level, temporary closure of a site...) and/or to operate according to EU GMP: 

Date Substance Name CEP Number
26/06/09  Ephedrine Hydrochloride 

2004-152

26/06/09  Pseudoephedrine Hydrochloride 

2004-153

26/06/09  Rutoside trihydrate 

2005-241

The EDQM also gave notice of the withdrawal of the following CEPs - as failure to fullfil, after a suspension, the requirements of the CEP procedure with regards to the updating of the application and compliance with GMP:

Date Substance Name CEP Number
03/06/09  Tolbutamide  2003-006
25/05/09  Acetylsalicylic Acid  2000-013

CEP Source: EDQM Webpage www.edqm.eu

As with the previously suspended CEPs these actions are also referring to Chinese and Indian manufacturers only.

User of those APIs/manufacturing sites mentioned above urgently need to evaluate the necessary actions resulting from these announcements.

The EDQM offers a database in which the information on the Certificates of Suitability (CEPs) is available for public. The addresses of the manufacturing sites related to the above mentioned CEPs can be obtained here.

 

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