沙坦类产品CEP证书申请更新

2018-12-20 10:36:49.0

根据近期收到的关于CEP证书中活性成分中出现的亚硝胺杂质的信息,EQDM立即采取了对CEPs证书的方案,直至相关生产企业采取并执行了有效的纠正方案。


Update on the review of CEP applications for sartans

2018-12-20 10:36:49.0

Followingnew information received recently about the presence of nitrosamine impuritiesin drug substances covered by certificates of suitability (CEPs), the EDQM hastaken immediate actions on CEPs until appropriate corrective actions areimplemented by the relevant companies: