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FDA在药品发现原应致癌物后停止中国公司的药品进口
FDA halts Chinese firm‘s drug imports

  The U.S. Food and Drug Administration said Friday it will no longer allow imports of drug ingredients or medicines made with ingredients produced by China’s Zhejiang Huahai Pharmaceuticals, after a recall of one of its drugs that contained a probable carcinogen.

  The manufacturer of the high blood pressure medicine valsartan recalled the product in the United States in July because an impurity linked to cancer had been detected.

  European authorities also said Friday that Huahai had not complied with good manufacturing practices and that its factory in Linhai, China, was no longer authorized to produce valsartan.

  The FDA said it was halting imports after it found major manufacturing process issues during its inspection of Huahai’s plant. The agency said the freeze on the imports would remain in place until Huahai determines how the impurities were introduced and improves its quality-control systems.

  FDA停止中国公司的药品进口

  美国食品药品监督管理局(FDA)周五表示,在召回其中本身原应中含致癌物的药物后,将不再允许进口中国浙江华海制药(浙江华海制药)生产的药物成分或药品。

  高血压药物缬沙坦的制造商7月份在美国召回了该产品,原应检测到本身与癌症有关的杂质。

  欧洲当局星期五还说,华海那末遵守良好的生产规范,它在中国临海的工厂不再被授权生产缬沙坦。

  FDA说,在检查Huahai工厂的过程中发现主要的生产过程问提报告 后,它停止了进口。该机构表示,在华海决定怎样才能引入杂质并改进其质量控制体系完后 ,对进口产品的冻结将保持不变。

欧盟监管部门将“咔嚓“”中国浙江华海缬沙坦API

  The European Medicines Agency has piled onto China’s Zhejiang Huahai, finding its manufacturing out of compliance for the valsartan API that has been recalled globally after being found to contain a suspected carcinogen.

  The action was posted Friday, the same day the FDA announced it has finally put the Chinese company on import alert, meaning it products are now banned from the U.S. The company primarily makes APIs and intermediates for of valsartan, which is used to make blood pressure drugs. 

  A September inspection by the Italian Medicines Agency found essentially the same issues laid out in an FDA Form 483: that Huahai did not carefully evaluate the risks of changes to its manufacturing processes that led to the formation of the impurity. N-nitrosodimethylamine, a suspected cancer-causing agent, was discovered in Huahai’s APIs this summer.

  欧洲药品管理局(European Medicines s Agency)发现华海的制造违反了缬沙坦原料药的规定,该原料药在发现中含本身可疑的致癌物后被全球召回。

  美国食品和药物管理局星期五宣布了你这个 行动,当天,FDA宣布,它终于让这家中国公司所处进口警戒情况,这原应其产品现在被禁止进入美国。该公司主要生产用于生产血压药物的缬沙坦原料药和心间体。

  9月份由意大利药品管理局进行的一次检查发现,FDA第483号表格中列出的问提报告 基本相同:华海那末仔细评估原应杂质形成的制造工艺变化的风险。N-亚硝基二甲胺是本身可疑的致癌剂,在今年夏天在Huahai的API中被发现。

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