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
2019	Perindopril tert-butylamine, Process 2, Micronised and Non-micronised	ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN	100011833;100018698	CEP 2020-356 - Rev 01	2025/11/10	Valid		Chemical	2025/11/10	Renewal\|CEP granted\|10/11/2025; Notification\|Accepted - CEP remains valid\|03/09/2024; Minor revision\|Accepted - CEP remains valid\|28/11/2022; Minor revision\|Accepted - CEP remains valid\|22/02/2022; New application\|CEP granted\|24/02/2021
883	Calcitriol	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 1998-055 - Rev 09	2025/11/06	Valid		Chemical	2025/11/06	Notification\|CEP granted\|06/11/2025; Minor revision\|CEP granted\|25/04/2025; Monograph revision\|Accepted - CEP remains valid\|26/11/2024; Minor revision\|CEP granted\|16/08/2024; Notification\|Rejected\|06/06/2024; Notification\|Accepted - CEP remains valid\|06/06/2023; Minor revision\|Accepted - CEP remains valid\|21/04/2022; Notification\|CEP granted\|20/12/2021; Minor revision\|CEP granted\|09/06/2021
2825	Tigecycline	ZHEJIANG HISUN PHARMACEUTICAL CO., LTD. Taizhou City CN	100011825;100018687	CEP 2024-176 - Rev 01	2025/11/06	Valid	10/09/2030	Chemical	2025/11/06	Notification\|CEP granted\|06/11/2025; New application\|CEP granted\|10/09/2025
2124	Loratadine	VASUDHA PHARMA CHEM LIMITED Hyderabad IN	100011811;100018603	CEP 2009-009 - Rev 04	2025/11/05	Valid		Chemical	2025/11/05	Minor revision\|CEP granted\|05/11/2025; Notification\|CEP granted\|30/01/2023; Minor revision\|Accepted - CEP remains valid\|12/12/2022; Notification\|Accepted - CEP remains valid\|20/09/2021; Minor revision\|CEP granted\|12/10/2020
967	Acetylcysteine	ZHEJIANG CDMO PHARMACEUTICAL CO., LTD Jinhua CN	100051857;100091157	CEP 2024-393 - Rev 00	2025/11/05	Valid	05/11/2030	Chemical	2025/11/05	New application\|CEP granted\|05/11/2025
2131	Tamsulosin hydrochloride	COHANCE LIFESCIENCES LIMITED Mumbai IN	100011755;100090273	CEP 2012-309 - Rev 03	2025/11/05	Valid		Chemical	2025/11/05	Major revision\|CEP granted\|05/11/2025; Notification\|CEP granted\|15/12/2022; Minor revision\|CEP granted\|04/01/2022
2465	Irbesartan	CTX LIFESCIENCES PVT. LIMITED Surat IN	100019102;100027863	CEP 2011-139 - Rev 07	2025/11/05	Valid		Chemical	2025/11/05	Administrative procedure\|CEP granted\|05/11/2025; Minor revision\|CEP granted\|24/10/2025; Major revision\|CEP granted\|16/06/2023; Minor revision\|CEP granted\|09/08/2021; Minor revision\|CEP granted\|11/12/2020
549	Dexamethasone sodium phosphate, Process II	TIANJIN TIANYAO PHARMACEUTICALS CO., LTD. Tianjin CN	100011805;100018616	CEP 2020-271 - Rev 01	2025/11/05	Valid	31/03/2027	Chemical and TSE	2025/11/05	Minor revision\|CEP granted\|05/11/2025; New application\|CEP granted\|31/03/2022
2358	Teicoplanin	DONGKOOK PHARMACEUTICAL CO., LTD. Seoul KR	100019576;100098744	CEP 2009-335 - Rev 05	2025/11/05	Valid		Chemical	2025/11/05	Notification\|CEP granted\|05/11/2025; Notification\|CEP granted\|19/10/2022; Notification\|Accepted - CEP remains valid\|14/09/2020
354	Prednisone	ZHEJIANG XIANJU PHARMACEUTICAL CO., LTD. Taizhou CN	100022759;100031459	CEP 2018-027 - Rev 03	2025/11/05	Valid		Chemical	2025/11/05	Minor revision\|CEP granted\|05/11/2025; Renewal\|CEP granted\|02/04/2024; Minor revision\|CEP granted\|18/03/2022; Notification\|Accepted - CEP remains valid\|06/08/2020
2422	Oseltamivir phosphate	BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO., LTD. Suzhou CN	100011974;100021627	CEP 2022-488 - Rev 01	2025/11/05	Valid	07/03/2029	Chemical	2025/11/05	Minor revision\|CEP granted\|05/11/2025; New application\|CEP granted\|07/03/2024
3052	Lercanidipine hydrochloride, Hemihydrate, Amorphous form	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2024-593 - Rev 00	2025/11/05	Valid	05/11/2030	Chemical	2025/11/05	New application\|CEP granted\|05/11/2025
2751	Valaciclovir hydrochloride hydrate	ATUL BIOSCIENCE LIMITED Ambernath (East) IN	100044514;100086818	CEP 2024-401 - Rev 00	2025/11/03	Valid	03/11/2030	Chemical	2025/11/03	New application\|CEP granted\|03/11/2025
3132	Mirabegron	SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN	100032307;100078783	CEP 2024-015 - Rev 00	2025/11/03	Valid	03/11/2030	Chemical	2025/11/03	New application\|CEP granted\|03/11/2025
2617	Aripiprazole	JUBILANT BIOSYS LIMITED Nanjangud IN	100055198;100098088	CEP 2013-324 - Rev 02	2025/11/03	Valid		Chemical	2025/11/03	Notification\|CEP granted\|03/11/2025; Minor revision\|Accepted - CEP remains valid\|30/04/2024; Notification\|CEP granted\|11/08/2022; Notification\|Accepted - CEP remains valid\|13/12/2021; Renewal\|CEP granted\|08/07/2021
1425	Fosfomycin trometamol	LABIANA PHARMACEUTICALS, S.L.U. Corbera de Llobregat ES	100000356;100010380	CEP 2012-265 - Rev 06	2025/11/03	Valid		Chemical	2025/11/03	Minor revision\|CEP granted\|03/11/2025; Notification\|Accepted - CEP remains valid\|04/07/2025; Notification\|CEP granted\|27/02/2024; Administrative procedure\|CEP granted\|23/11/2023; Notification\|CEP granted\|24/10/2023; Notification\|CEP granted\|17/12/2021; Minor revision\|CEP granted\|18/10/2021; Minor revision\|Accepted - CEP remains valid\|07/04/2020
1491	Amlodipine besilate, Micronised and non-micronised	ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN	100011833;100018698	CEP 2016-282 - Rev 01	2025/11/03	Valid		Chemical	2025/11/03	Major revision\|CEP granted\|03/11/2025; Renewal\|CEP granted\|06/07/2023; Minor revision\|Accepted - CEP remains valid\|13/07/2022; Minor revision\|Accepted - CEP remains valid\|26/04/2021; Minor revision\|CEP granted\|14/05/2020
.	Bovine pericardial tissue	BRIDGEMED SOLUTIONS, INC. Irvine US	100055072;100097778	CEP 2020-257 - Rev 01	2025/11/03	Valid		TSE	2025/11/03	Renewal\|CEP granted\|03/11/2025; New application\|CEP granted\|07/05/2021
1373	Testosterone	JIANGSU JIAERKE PHARMACEUTICALS GROUP CO., LTD. Changzhou CN	100019383;100028149	CEP 2023-439 - Rev 00	2025/11/03	Valid	03/11/2030	Chemical	2025/11/03	New application\|CEP granted\|03/11/2025
1611	Diosmin, Process 2	BIORESINE INTERNATIONALE Kenitra MA	100015357;100092292	CEP 2024-565 - Rev 00	2025/11/03	Valid	03/11/2030	Chemical	2025/11/03	New application\|CEP granted\|03/11/2025

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)	-