# \[e-drug\] French drug firm pleads guilty (cont'd)

**URL:** <https://talk.edrugplus.org/t/e-drug-french-drug-firm-pleads-guilty-contd/12773>\
**Category:** e-drug\
**Created:** [October 23, 2001, 6:34pm UTC](https://talk.edrugplus.org/t/e-drug-french-drug-firm-pleads-guilty-contd/12773 "2001-10-23T18:34:34Z")\
**Posts on this page:** 1\
**Page:** 1

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**Author:** ![lo1](https://avatars.discourse-cdn.com/v4/letter/l/e68b1a/32.png) [@lo1](https://talk.edrugplus.org/u/lo1)\
**Post date:** [October 23, 2001, 6:34pm UTC](https://talk.edrugplus.org/t/e-drug-french-drug-firm-pleads-guilty-contd/12773/1 "2001-10-23T18:34:34Z")

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E-drug: French drug firm pleads guilty (cont'd)  
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Dear friends,

Cefaclor made in Romania? This sounds embarrassingly familiar.  
The only possible source is the former state-run plant of  
"Antibiotica" in Iasi near the Moldovian border. When I was a  
EU/Phare consultant for the "reconstruction of the pharmaceutical  
sector in Romania" in 1999-2000, the management of Antibiotica  
steadfastly refused to cooperate with the National Drug Policy  
programme. Because they produced many sophisticated drugs  
which were not needed in this nearly bankrupt country I  
recommended to close down most production facilities and let the  
manufacturer restrict his activities to penicillin and derivatives; there  
was already a huge problem with MSRA so we warned against the  
unbridled use of cephalosporins. Several pharmacy professors from  
Iasi University were members of our group, and from them I heard  
the most horrifying stories about Antibiotica; rats running around in  
the warehouses, raw materials lying around on the premises in the  
sun, with fluid leaking from the packaging material, etc. We  
requested a GMP inspection but were told that the factory had  
received a GMP certificate from the Drug Agency in Bucharest, and  
that a visit was not opportune.

I do not know how the situation is at present, but the issue should  
be taken up by the EMEA if Romania wants to become a honest  
member of the EU.

Best wishes,

Dr.L.Offerhaus  
Koedijklaan 1a  
1406 KW Bussum  
The Netherlands  
Phone +31-35-6923288  
Fax +31-35-6923277 (number changed since 1.11.01)  
E-mail: lo@euronet.nl

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