CEP Withdrawal: R0-CEP 2011-240-Rev 01/Nitrofurantoin – Pharmaceutical Workshop: Jinan Jinda Pharmaceutical Chemistry Co., Ltd (CHINA) (04/08/2016)
We inform you that, following the inspection carried out as part of the EDQM inspection program (24-26 June 2016) at the Chinese site in question, it was found not to be "in compliance" with the GMPs.
It should be underlined that the CEP issued for the production of the pharmacologically active raw material and/or production intermediate: NITROFURANTOIN had already been suspended in 2015, therefore, the EDQM has taken the decision to withdraw the following certificate: R0-CEP 2011- 240-Rev 01/NITROFURANTOIN.
Companies are asked to urgently verify whether, for medicines containing the following active substance and/or production intermediate: NITROFURANTOIN, authorized for the Italian market and/or products for export, the Pharmaceutical Workshop is present as an authorized supplier: JINANJINDA 
PHARMACEUTICAL CHEMISTRY CO., LTD No. 6121 Longquan Road China – 250 200 Zhangqiu, Shandong Province – CHINA .
ALONE in the event of a positive response, the Company must immediately notify it, indicate the possible presence of an alternative production site to the one in question and proceed with the change request for the elimination of the aforementioned site or indicate the absence of a production site alternative and proceed with the change request for replacement of the Chinese site in question.
Lastly, it is required for medicines authorized with mutual recognition procedure, to specify the European procedure code.
The notification must be received within the day August 10, 2016, to the following mailbox:
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