{"id":27439,"date":"2016-08-05T08:10:30","date_gmt":"2016-08-05T06:10:30","guid":{"rendered":"http:\/\/www.fedaiisf.it\/?p=27439"},"modified":"2016-08-05T13:27:36","modified_gmt":"2016-08-05T11:27:36","slug":"nitrofurantoina-materia-prima-cinese-ritirata","status":"publish","type":"post","link":"https:\/\/www.fedaiisf.it\/en\/nitrofurantoina-materia-prima-cinese-ritirata\/","title":{"rendered":"Chinese raw material nitrofurantoin withdrawn"},"content":{"rendered":"<h1 id=\"page-title\">CEP Withdrawal: R0-CEP 2011-240-Rev 01\/Nitrofurantoin \u2013 Pharmaceutical Workshop: Jinan Jinda Pharmaceutical Chemistry Co., Ltd (CHINA) (04\/08\/2016)<\/h1>\n<p><img decoding=\"async\" class=\"alignleft\" src=\"http:\/\/www.jindapharm.com\/Html\/Index\/images\/index_01.jpg\" alt=\"\" \/>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 &quot;in compliance&quot; with the GMPs.<\/p>\n<p>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.<\/p>\n<p>Companies are asked to urgently verify whether, for medicines containing the following active substance and\/or production intermediate: <strong>NITROFURANTOIN<\/strong>, authorized for the Italian market and\/or products for export, the Pharmaceutical Workshop is present as an authorized supplier: <strong>JINANJINDA <img loading=\"lazy\" decoding=\"async\" class=\"alignright\" src=\"http:\/\/img.en.cphi.cn\/img_Cphi_en\/Products\/2011_06\/Pr_1106081458573B18.jpg\" alt=\"\" width=\"248\" height=\"186\" \/>PHARMACEUTICAL CHEMISTRY CO., LTD No. 6121 Longquan Road China \u2013 250 200 Zhangqiu, Shandong Province \u2013 CHINA<\/strong> .<\/p>\n<p><strong>ALONE<\/strong> 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.<\/p>\n<p>Lastly, it is required for medicines authorized with <a class=\"glossary-term\" href=\"http:\/\/www.agenziafarmaco.gov.it\/it\/glossary\/term\/1473\" target=\"_blank\" rel=\"noopener\"><dfn title=\"Mutual recognition mechanism between different EU member countries of the marketing authorization of a drug. It can only be used for traditional medicines.\">mutual recognition procedure<\/dfn><\/a>, to specify the European procedure code.<\/p>\n<p>The notification must be received within the day<strong> \u00a0August 10, 2016<\/strong>, to the following mailbox:<\/p>\n<ul>\n<li><strong><a class=\"mailto\" href=\"mailto:infocepgmp@aifa.gov.it\">infocepgmp@aifa.gov.it<\/a><\/strong><\/li>\n<\/ul>\n<p><a href=\"http:\/\/www.agenziafarmaco.gov.it\/it\/content\/ritiro-cep-r0-cep-2011-240-rev-01nitrofurantoina-officina-farmaceutica-jinan-jinda-pharmaceu\" target=\"_blank\" rel=\"noopener\"><span style=\"color: #0000ff;\">AIFA \u2013 08\/04\/2016<\/span><\/a><\/p>\n<p>_______________________________________<\/p>\n<p>Related news: <a href=\"http:\/\/www.accessdata.fda.gov\/cms_ia\/importalert_189.html\" target=\"_blank\" rel=\"noopener\"><span style=\"color: #0000ff;\">FDA. Import Alerts 66-40<\/span><\/a><\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>Ritiro CEP: R0-CEP 2011-240-Rev 01\/nitrofurantoina &#8211; Officina farmaceutica: Jinan Jinda Pharmaceutical Chemistry Co., Ltd (CINA) (04\/08\/2016) Si comunica che, a seguito dell\u2019ispezione condotta nell\u2019ambito del programma di ispezioni dell\u2019EDQM (24-26 giugno 2016) presso il sito cinese in oggetto, lo stesso \u00e8 risultato non \u201cin compliance\u201d con le GMP. Si sottolinea, che il CEP rilasciato per &hellip;<\/p>","protected":false},"author":4,"featured_media":27443,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[49,56,31],"class_list":["post-27439","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizie","tag-aifa","tag-cina","tag-generici"],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts\/27439","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/comments?post=27439"}],"version-history":[{"count":0,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts\/27439\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/media\/27443"}],"wp:attachment":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/media?parent=27439"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/categories?post=27439"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/tags?post=27439"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}