Further CEPs suspended and withdrawn by EDQM

The EDQM continues to inspect manufacuturers of APIs - especially in Asia. As a consequence of these inspections a number of CEPs were supspended or withdrawn (GMP News 20.1.2010 and GMP News 29.04.2009). In addition to previous announcements the EDQM published the suspension of 3 and the withdrawal of 4 CEPs on their website.  All of the CEP owners are Indian and Chinese companies.

The EDQM announces the suspension of the following CEPs as a result of an inspection of the manufacturing sites:

Date Substance name  CEP Number
14/12/2009 Carbamazepine CEP 2002-141
31/03/2010 Chlorpropamide CEP 2000-020
31/03/2010 Tolbutamide CEP 2000-021

The EDQM announces the withdrawal of the following CEP as a result of an inspection of the manufacturing sites:

Date Substance name CEP Number
26/02/2010 Propyphenazone CEP 2001-041
26/02/2010 Phenazone CEP 2001-042
26/02/2010 Metamizole sodium CEP 2001-220
04/01/2010 Zidovudine CEP 2003-276

The EDQM offers a database in which the information on the Certificates of Suitability (CEPs) are available for public. The database offers a comprehensive search tool. It is possible to search for:

  • Name of the certified substance or
  • Holder of the certificate or
  • Certificate number or
  • Monograph number or
  • Status of the certificate

The database can be found here.

Source: www.edqm.eu.

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