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CEP Suspensions
a) Following inspection of the manufacturing site(s)
DateSubstance nameCEP Number
22/02/13NorfloxacinCEP 2001-409
22/02/13Metformin hydrochlorideCEP 2005-232
22/02/13CarbidopaCEP 2006-138
22/02/13Amlodipine besilateCEP 2007-285
22/02/13Ciprofloxacin hydrochlorideCEP 2011-051
20/02/13 Ciprofloxacin HydrochlorideCEP 2005-262
20/02/13 SimvastatinCEP 2005-300
06/12/12Ferrous gluconateCEP 2009-150
11/09/12CiclosporinCEP 2006-223其中有两家是中国企业
1.台山市化学制药有限公司 环孢霉素
2.浙江京新药业股份有限公司 辛伐他汀 盐酸环丙沙星
| Substance
Number | Substance | Certificate Holder | Certificate Number | Issue
Date | Status | Type | | Ciclosporin | TAISHAN CITY CHEMICAL PHARMACEUTICAL CO., LTD. CN 529 200 Taishan City | R0-CEP 2006-223-Rev 01 | 23/04/2010 | SUSPENDED | Chemistry |
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Substance
Number | Substance | Certificate Holder | Certificate Number | Issue
Date | Status | Type | | Simvastatin | ZHEJIANG JINGXIN PHARMACEUTICAL CO., LTD. CN 312 500 Xinchang | R0-CEP 2005-300-Rev 05 | 12/07/2012 | SUSPENDED | Chemistry |
Substance
Number | Substance | Certificate Holder | Certificate Number | Issue
Date | Status | Type | | Ciprofloxacin Hydrochloride | ZHEJIANG JINGXIN PHARMACEUTICAL CO., LTD. CN 312 500 Xinchang | R0-CEP 2005-262-Rev 03 | 22/09/2011 | SUSPENDED | Chemistry |
知道这两个企业的情况说说,讨论一下为什么检查之后被暂停CEP证书? |
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