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September 10, 2009 - MEB removes raw material manufacturer from authorisation file
The Medicines Evaluation Board (MEB) on 27 August has removed the
raw material manufacturer Glochem (from Bollaram, India) from
authorisation files because quality requirements were not
fulfilled. There are no indications that medicinal products that
are already in the possession of patients are unsafe for use.
The stimulus for the MEB decision is information from the EDQM
(European Directorate for the Quality of Medicines &
Healthcare, division of the Council of Europe) that established
after inspection that the manufacture of the active ingredients
amlodipine besilate and cetirizine no longer fulfilled the quality
requirements for good manufacturing practice (GMP Guidelines).
As a result, there is a risk that products from this manufacturer
will not fulfil quality requirements.
For the company Glochem (Bollaram, India) this means that it is
no longer an approved raw material manufacturer and that the MEB
has removed it from the authorisation files. The marketing
authorisation holders have been informed of this.
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