欧洲药典适用性证书数据库（欧盟CEP认证）

专论编号	物质名称	证书持有人	持有人ORG-ID和LOC-ID	证书编号	发布日期	证书状态	到期续期	证书类型	上一程序的结束日期	历史数据程序类型\|结论\|日期
1724	Formoterol fumarate dihydrate	VAMSI LABS LIMITED Solapur IN	100014747;100096958	CEP 2006-227 - Rev 03	2025/06/24	Valid		Chemical	2025/06/24	Notification\|CEP granted\|24/06/2025; Notification\|Accepted - CEP remains valid\|22/09/2023; Notification\|CEP granted\|28/07/2022; Monograph revision\|Accepted - CEP remains valid\|06/05/2022
616	Haloperidol	MANKIND PHARMA LIMITED New Delhi IN	100040218;100065486	CEP 2020-026 - Rev 03	2025/06/24	Valid	05/01/2027	Chemical	2025/06/24	Administrative procedure\|CEP granted\|24/06/2025; Notification\|CEP granted\|06/06/2025; Major revision\|CEP granted\|22/02/2024; New application\|CEP granted\|05/01/2022
559	Mannitol, For use in the manufacture of parenteral preparations	CARGILL S.R.L. Castelmassa IT	100049176;100083235	CEP 2005-019 - Rev 03	2025/06/24	Valid		Chemical	2025/06/24	Notification\|CEP granted\|24/06/2025
2002	Proguanil hydrochloride	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2011-182 - Rev 01	2025/06/24	Valid		Chemical	2025/06/24	Minor revision\|CEP granted\|24/06/2025; Notification\|Accepted - CEP remains valid\|08/01/2024; Minor revision\|Accepted - CEP remains valid\|19/04/2022; Notification\|Accepted - CEP remains valid\|15/01/2021
1765	Salmeterol xinafoate, Non-micronised and micronised	VAMSI LABS LIMITED Solapur IN	100014747;100096958	CEP 2006-226 - Rev 04	2025/06/24	Valid		Chemical	2025/06/24	Notification\|CEP granted\|24/06/2025; Minor revision\|CEP granted\|05/03/2024; Notification\|CEP granted\|28/07/2022
1794	Paclitaxel, Produced by semi-synthetic process	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2009-236 - Rev 06	2025/06/24	Valid		Chemical	2025/06/24	Minor revision\|CEP granted\|24/06/2025; Major revision\|CEP granted\|25/11/2024; Minor revision\|CEP granted\|27/02/2024; Minor revision\|CEP granted\|19/11/2021
616	Haloperidol	VAMSI LABS LIMITED Solapur IN	100014747;100096958	CEP 2020-149 - Rev 01	2025/06/24	Valid	04/04/2028	Chemical	2025/06/24	Notification\|CEP granted\|24/06/2025; Minor revision\|Accepted - CEP remains valid\|20/08/2024; Minor revision\|Accepted - CEP remains valid\|09/01/2024; Notification\|Rejected\|26/09/2023; New application\|CEP granted\|04/04/2023
1409	Clenbuterol Hydrochloride	VAMSI LABS LIMITED Solapur IN	100014747;100096958	CEP 2020-172 - Rev 02	2025/06/24	Valid	30/03/2027	Chemical	2025/06/24	Notification\|CEP granted\|24/06/2025; Notification\|Accepted - CEP remains valid\|21/09/2023; Notification\|CEP granted\|28/07/2022; New application\|CEP granted\|30/03/2022
1431	Haloperidol decanoate	MANKIND PHARMA LIMITED New Delhi IN	100040218;100065486	CEP 2020-080 - Rev 03	2025/06/24	Valid	20/05/2027	Chemical	2025/06/24	Administrative procedure\|CEP granted\|24/06/2025; Notification\|CEP granted\|06/06/2025; Minor revision\|Accepted - CEP remains valid\|08/11/2024; Major revision\|CEP granted\|30/08/2024; New application\|CEP granted\|20/05/2022
901	Fenoterol hydrobromide	VAMSI LABS LIMITED Solapur IN	100014747;100096958	CEP 2020-160 - Rev 03	2025/06/24	Valid	08/03/2027	Chemical	2025/06/24	Notification\|CEP granted\|24/06/2025; Minor revision\|CEP granted\|14/11/2023; Notification\|Rejected\|21/09/2023; Notification\|CEP granted\|28/07/2022; New application\|CEP granted\|08/03/2022
1750	Fluticasone propionate, Micronised	VAMSI LABS LIMITED Solapur IN	100014747;100096958	CEP 2020-078 - Rev 03	2025/06/24	Valid	29/10/2026	Chemical	2025/06/24	Notification\|CEP granted\|24/06/2025; Minor revision\|CEP granted\|11/12/2023; Notification\|CEP granted\|28/07/2022; New application\|CEP granted\|29/10/2021
2191	Atorvastatin calcium, Trihydrate	MANKIND PHARMA LIMITED New Delhi IN	100040218;100065486	CEP 2022-262 - Rev 02	2025/06/24	Valid	16/02/2029	Chemical	2025/06/24	Administrative procedure\|CEP granted\|24/06/2025; Notification\|CEP granted\|06/06/2025; New application\|CEP granted\|16/02/2024
2931	Sorafenib tosilate, Form-I	MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN	100011732;100023530	CEP 2023-185 - Rev 01	2025/06/24	Valid	29/10/2029	Chemical	2025/06/24	Monograph revision\|CEP granted\|24/06/2025; New application\|CEP granted\|29/10/2024
919	Ipratropium bromide, Micronised	VAMSI LABS LIMITED Solapur IN	100014747;100096958	CEP 2023-137 - Rev 01	2025/06/24	Valid	05/11/2029	Chemical	2025/06/24	Notification\|CEP granted\|24/06/2025; New application\|CEP granted\|05/11/2024
1250	Omega-3-acid ethyl esters 90, Code K85EE - containing alpha tocopherol as antioxidant	BASF AS Oslo NO	100003052;100032709	CEP 2008-132 - Rev 05	2025/06/23	Valid		Chemical	2025/06/23	Minor revision\|CEP granted\|23/06/2025; Notification\|Accepted - CEP remains valid\|25/07/2023; Notification\|CEP granted\|21/01/2020
2541	Quetiapine Fumarate	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2017-210 - Rev 05	2025/06/23	Valid		Chemical	2025/06/23	Minor revision\|CEP granted\|23/06/2025; Renewal\|CEP granted\|17/04/2024; Minor revision\|CEP granted\|19/12/2023; Minor revision\|CEP granted\|15/11/2022; Minor revision\|CEP granted\|10/01/2022; Minor revision\|Accepted - CEP remains valid\|06/11/2020
2779	Solifenacin succinate	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2016-059 - Rev 02	2025/06/23	Valid		Chemical	2025/06/23	Minor revision\|CEP granted\|23/06/2025; Notification\|CEP granted\|16/01/2024; Renewal\|CEP granted\|27/09/2022
1524	Gliclazide, AP	BAL PHARMA LIMITED Bengaluru IN	100016398;100041736	CEP 2013-039 - Rev 03	2025/06/23	Valid		Chemical	2025/06/23	Notification\|CEP granted\|23/06/2025; Administrative procedure\|CEP granted\|03/03/2025; Minor revision\|CEP granted\|13/02/2025; Renewal\|CEP granted\|27/08/2020
1250	Omega-3-acid ethyl esters 90, Code 03 K85EE - containing alpha tocopherol as antioxidant	BASF AS Oslo NO	100003052;100032709	CEP 2008-330 - Rev 05	2025/06/23	Valid		Chemical	2025/06/23	Minor revision\|CEP granted\|23/06/2025; Notification\|Accepted - CEP remains valid\|25/07/2023; Notification\|CEP granted\|21/01/2020
1563	Simvastatin, BHA, Process II	SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN	100023303;100032437	CEP 2025-108 - Rev 00	2025/06/23	Valid	23/06/2030	Chemical	2025/06/23	New application\|CEP granted\|23/06/2025

专论编号 (Monograph Number)
物质名称 (Substance)
证书持有人 (Certificate (CEP) Holder)
证书编号 (Certificate (CEP) Number)
证书类型 (Type CEP)
证书状态 (Status CEP)
发布日期(Issue Date CEP)	-
证书效期(End date CEP)	-