To

All the Members of Council,

Dear Member,

Sub: Compilation & Analysis of EDQM CEPs database

Members are aware that the European Directorate of Quality Medicine (EDQM) grants Certificates of Suitability of European Pharmacopoeia monographs (CEPs) to manufacturer or suppliers of the pharmaceutical substance, when they have demonstrated compliance with the monographs of the European Pharmacopoeia.  CEPs are the means by which Marketing Authorisation applicants should submit data on most pharmacopoeia active ingredients prepared by synthesis, fermentation or semi-synthesis, in order to satisfy licensing authorities regarding CMC (chemistry, manufacturing, control) & stability requirements. The CEP is a centralize procedure at EDQM and valid for 36 countries around the world.  It guarantees that all the impurities and potential contaminations related to the manufacturing process are satisfactorily controlled using the requirement of European Pharmacopoeia monographs and the quality of the substance is appropriate for use in medicine.

Considering the importance of CEPs for our pharmaceutical export member companies (both API & formulation manufacturer), Pharmexcil has carried out an extensive search and compiled a database on CEPs.

By July 2010, of the total 2,858 valid CEPs approved to 803 companies globally (belonging to 51 countries) with EDQM, India has filled 687 valid CEPs (24.04% of total) by 143 and is currently the largest CEPs certificate holder with EDQM.  

 For in-depth details regarding the CEPs number, company, site of manufacture, molecule etc (relating India and/or Global), member may contact Pharmexcil at research@pharmexcil.com. Pharmexcil will be happy to provide such information at a very nominal price.

 
With regards,
 
Dr.P.V. Appaji