Chinese raw material nitrofurantoin withdrawn

Ritiro CEP: R0-CEP 2011-240-Rev 01/nitrofurantoina – Officina farmaceutica: Jinan Jinda Pharmaceutical Chemistry Co., Ltd (CINA) (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, autorizzati per il mercato italiano e/o prodotti per l’esportazione, risulti presente come fornitore autorizzato, l’Officina Farmaceutica: JINANJINDA PHARMACEUTICAL CHEMISTRY CO., LTD No. 6121 Longquan Road China – 250 200 Zhangqiu, Shandong Province – CINA .

ALONE in caso di riscontro positivo l’Azienda dovrà darne immediata comunicazione, indicare l’eventuale presenza di un sito di produzione alternativo a quello in oggetto e procedere alla richiesta di variazione per l’eliminazione del sito suindicato ovvero indicare l’assenza di sito di produzione alternativo e procedere alla richiesta di variazione per sostituzione del sito cinese in oggetto.

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:

AIFA – 04/08/2016

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