WHO对FDA针对于上海迪赛诺（原料厂）的警告信做出回应

beiwei5du

WHO对FDA针对于迪赛诺的警告信做出回应：desano prequalification status仍然有效，会继续关注后期的调查处理情况，通过WHO prequalification的FPP仍然可以采购迪赛诺的原料药进行成品生产，但是要增加相应的来货检查措施，以确保质量（毕竟是救死扶伤的第三世界急需用药）。
那么这样以来至少现阶段，迪赛诺至少在WHO的药品阶段采购并未受到影响。


原文请见：WHO response to the US FDA Warning Letter issued for Shanghai Desano Chemical Pharmaceutical API manufacturing site
http://apps.who.int/prequal/info_press/documents/2016/ShanghaiDesano_WarningLetter_July2016.pdf


其中9个原料药分别是：

Lamivudine	Shanghai  Desano Chemical Pharmaceutical Co Ltd	Shanghai  Desano Chemical Pharmaceutical Co Ltd     417 Binhai Road     Laogang Town, Pudong New Area     Shanghai     201 302     China (People's Republic of)
Zidovudine	Shanghai Desano Chemical Pharmaceutical Co Ltd	Shanghai Desano Chemical Pharmaceutical Co Ltd     417 Binhai Road     Laogang Town, Pudong New Area     Shanghai     201 302     China (People's Republic of)
Artemether	Shanghai Desano Chemical Pharmaceutical Co Ltd	Shanghai Desano Chemical Pharmaceutical Co Ltd     417 Binhai Road     Laogang Town, Pudong New Area     Shanghai     201 302     China (People's Republic of)
Lumefantrine	Shanghai Desano Chemical Pharmaceutical Co Ltd	Shanghai Desano Chemical Pharmaceutical Co Ltd     417 Binhai Road     Laogang Town, Pudong New Area     Shanghai     201 302     China (People's Republic of)
Nevirapine	Shanghai Desano Chemical Pharmaceutical Co Ltd	Shanghai Desano Chemical Pharmaceutical Co Ltd     417 Binhai Road     Laogang Town, Pudong New Area     Shanghai     201 302     China (People's Republic of)
Efavirenz	Shanghai Desano Chemical Pharmaceutical Co Ltd	Shanghai Desano Chemical Pharmaceutical Co Ltd     417 Binhai Road     Laogang Town, Pudong New Area     Shanghai     201 302     China (People's Republic of)
Ritonavir	Shanghai Desano Chemical Pharmaceutical Co Ltd	Shanghai Desano Chemical Pharmaceutical Co Ltd     417 Binhai Road     Laogang Town, Pudong New Area     Shanghai     201 302     China (People's Republic of)
Emtricitabine	Shanghai Desano Chemical Pharmaceutical Co Ltd	Shanghai Desano Chemical Pharmaceutical Co Ltd     417 Binhai Road     Laogang Town, Pudong New Area     Shanghai     201 302     China (People's Republic of)
Tenofovir disoproxil (fumarate)	Shanghai Desano Chemical Pharmaceutical Co Ltd	Shanghai Desano Chemical Pharmaceutical Co Ltd     417 Binhai Road     Laogang Town, Pudong New Area     Shanghai     201 302     China (People's Republic of)

lijianbing

持续关注中！！

hongyu

这个要看下

北重楼

看来现在检查缺陷都是通用的，被一个国家查到，另一个国家或区域就有可能采取措施

2A2MXnrNlF

患者不吃药肯定会死、吃了劣药不一定会死。