API´s from Asia at Risk - Further CEP´s Suspended

Many pharmaceutical companies are purchasing APIs from Asia. Current estimations are that around 70 to 80% of the total volume of APIs used for the manufacture of medicinal products for the European market is sourced from Asia. Current developments indicate that saving costs by sourcing lower-priced APIs from Asia may in quite a number of cases turn out to have been an unfortunate decision and companies in the end may lose far more, financially but also with regards to company reputation, than what they intended to gain through the anticipated savings.

The EDQM announces further suspensions of CEPs. As a result of inspections of the manufacturing sites, the following CEPs were suspended:

17/07/09 Amlodipine besilate CEP 2005-173
17/07/09 Cetirizine dihydrochloride CEP 2003-171
17/07/09 Amlodipine besilate CEP 2002-072

All three CEPs were held by a manufacturer in India. We had already reported about recently published suspensions in our GMP News of 1 July and in our GMP News of 29 April.

All of the 13 CEPs suspended or withdrawn by EDQM in 2009 were held by Chinese and Indian manufacturers. Moreover, also all other suspended/withdrawn CEPs in previous years related to API manufacture in Asia (but some of those were held by European traders). 

The consequence for the manufacturers of medicinal product who use these CEPs is changing dramatically. With the new EMEA Guidelines, about which we reported in our GMP News of 22 July, serious actions will be prompted in the future if a manufacturer of a medicinal product uses an API from a company whose CEP has been suspended because of non-GMP-compliant manufacturing or because of serious non-compliance with submitted information. This new development may trigger a drastic rethinking of API sourcing strategies. Many companies have now learned that a CEP does not confirm any GMP compliance (it has never been intended to give any assurance on the GMP status except for a holder's self-declaration included in the original dossier!). Still a large number of API manufacturers have never been inspected by the EDQM while part of the manufacturers of medicinal products may not yet have been inspected with focus on API sourcing included.
A new boost for increased inspection coverage will be the joint international API inspection programme that was recently initiated cooperatively by several authorities (including FDA, TGA, EU, EDQM). This initiative is expected to lead to a sharp increase in the number of API inspections in especially Asia. More CEP suspensions are therefore very likely to occur.
In addition already far-advanced new legislative API initiatives in the USA and in the EU are expected to further speed up this development. These will also increasingly affect API manufacture not covered by CEPs.


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