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
2287	Fluconazole	FDC Limited Mumbai IN	100011646;100021030	CEP 2016-286 - Rev 01	2026/02/19	Valid		Chemical	2026/02/19	Monograph revision\|CEP granted\|19/02/2026; Renewal\|CEP granted\|04/07/2023; Minor revision\|Accepted - CEP remains valid\|27/10/2022
1694	Gemfibrozil	HIKAL LIMITED Bengaluru IN	100014769;100023445	CEP 2007-089 - Rev 06	2026/02/19	Valid		Chemical	2026/02/19	Minor revision\|CEP granted\|19/02/2026; Minor revision\|Accepted - CEP remains valid\|23/01/2023; Notification\|Rejected\|06/12/2022; Notification\|CEP granted\|07/09/2022; Minor revision\|Accepted - CEP remains valid\|20/02/2020
562	Sodium cromoglicate	SANOFI AVENTIS SINGAPORE PTE LTD Singapore SG	100005144;100008271	CEP 2001-421 - Rev 04	2026/02/19	Valid		Chemical	2026/02/19	Notification\|CEP granted\|19/02/2026; Minor revision\|Accepted - CEP remains valid\|10/08/2022; Monograph revision\|Accepted - CEP remains valid\|16/06/2021
1096	Doxepin hydrochloride	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 1999-197 - Rev 06	2026/02/19	Valid		Chemical	2026/02/19	Major revision\|CEP granted\|19/02/2026; Minor revision\|CEP granted\|07/05/2025; Minor revision\|Accepted - CEP remains valid\|26/06/2023; Minor revision\|CEP granted\|08/12/2021; Minor revision\|Accepted - CEP remains valid\|12/06/2020
568	Propranolol hydrochloride	IPCA LABORATORIES LIMITED Mumbai IN	100011685;100018680	CEP 2002-026 - Rev 07	2026/02/19	Valid		Chemical	2026/02/19	Minor revision\|CEP granted\|19/02/2026; Minor revision\|CEP granted\|06/12/2023; Notification\|CEP granted\|03/08/2023; Minor revision\|CEP granted\|22/05/2023; Minor revision\|Accepted - CEP remains valid\|15/07/2022; Minor revision\|CEP granted\|21/09/2021; Minor revision\|Accepted - CEP remains valid\|01/04/2021; Minor revision\|Accepted - CEP remains valid\|13/03/2020
576	Allopurinol	EXEMED PHARMACEUTICALS Vadodara IN	100019154;100027915	CEP 2021-331 - Rev 01	2026/02/19	Valid	30/11/2027	Chemical	2026/02/19	Minor revision\|CEP granted\|19/02/2026; Notification\|Rejected\|26/11/2025; New application\|CEP granted\|01/12/2022
3087	Ticagrelor	ZHEJIANG HISUN PHARMACEUTICAL CO., LTD. Taizhou City CN	100011825;100018687	CEP 2024-020 - Rev 00	2026/02/19	Valid	19/02/2031	Chemical	2026/02/19	New application\|CEP granted\|19/02/2026
1792	Nicotine resinate, Nicotine content 18% with glycerol 9.0-11.0%	ALCHEM INTERNATIONAL PRIVATE LIMITED Faridabad IN	100011947;100018683	CEP 2019-030 - Rev 03	2026/02/19	Valid		Chemical	2026/02/19	Minor revision\|CEP granted\|19/02/2026; Renewal\|Accepted - CEP remains valid\|17/10/2025; Minor revision\|CEP granted\|19/05/2025; Minor revision\|CEP granted\|01/08/2022; Notification\|Rejected\|23/02/2022
2858	Mometasone furoate monohydrate, Micronised and non-micronised	BREATHGREEN PHARMACEUTICAL CO. LTD. Zaozhuang CN	100048781;100081153	CEP 2025-357 - Rev 00	2026/02/19	Valid	19/02/2031	Chemical	2026/02/19	New application\|CEP granted\|19/02/2026
2606	Tadalafil	SHANDONG CHENGHUI SHUANGDA PHARMACEUTICAL CO., LTD. Dezhou CN	100048410;100080174	CEP 2025-131 - Rev 01	2026/02/19	Valid	22/10/2030	Chemical	2026/02/19	Minor revision\|CEP granted\|19/02/2026; New application\|CEP granted\|22/10/2025
2600	Olmesartan medoxomil	TORRENT PHARMACEUTICALS LIMITED Ahmedabad IN	100004452;100001862	CEP 2023-126 - Rev 00	2026/02/19	Valid	19/02/2031	Chemical	2026/02/19	New application\|CEP granted\|19/02/2026
1425	Fosfomycin trometamol	GUILIN HWASUN PHARMACEUTICAL CO., LTD. Guilin CN	100034192;100054092	CEP 2025-152 - Rev 00	2026/02/19	Valid	19/02/2031	Chemical	2026/02/19	New application\|CEP granted\|19/02/2026
2857	Trazodone hydrochloride, Process-II, Milled/Unmilled	INTAS PHARMACEUTICALS LIMITED Ahmedabad IN	100011529;100023432	CEP 2025-141 - Rev 02	2026/02/19	Valid	13/11/2030	Chemical	2026/02/19	Administrative procedure\|CEP granted\|19/02/2026; Minor revision\|CEP granted\|03/02/2026; New application\|CEP granted\|13/11/2025
50	Procaine Hydrochloride	FLARER S.A. Balerna CH	100047920;100079248	CEP 2021-223 - Rev 03	2026/02/19	Valid	14/11/2027	Chemical	2026/02/19	Monograph revision\|CEP granted\|19/02/2026; Minor revision\|Accepted - CEP remains valid\|03/12/2025; Minor revision\|CEP granted\|24/02/2025; Minor revision\|CEP granted\|02/02/2024; New application\|CEP granted\|14/11/2022
52	Rifampicin	OLON S.P.A. Rodano IT	100012085;100019537	CEP 2009-275 - Rev 06	2026/02/18	Valid		Chemical	2026/02/18	Minor revision\|CEP granted\|18/02/2026; Minor revision\|CEP granted\|27/05/2024; Minor revision\|CEP granted\|27/07/2022; Major revision\|CEP granted\|24/11/2021
1756	Lamotrigine	ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN	100006039;100002980	CEP 2011-010 - Rev 06	2026/02/18	Valid		Chemical	2026/02/18	Minor revision\|CEP granted\|18/02/2026; Minor revision\|CEP granted\|03/02/2025; Minor revision\|CEP granted\|12/07/2024; Notification\|CEP granted\|19/06/2023; Minor revision\|CEP granted\|18/02/2022; Minor revision\|CEP granted\|06/04/2020
179	Erythromycin, Micronised, powder	ERCROS S.A. Aranjuez ES	100016091;100024873	CEP 2003-129 - Rev 03	2026/02/18	Valid		Chemical	2026/02/18	Minor revision\|CEP granted\|18/02/2026; Major revision\|Rejected\|04/11/2025; Monograph revision\|CEP granted\|26/03/2021
1615	Finasteride	SHAKTI LIFESCIENCE PRIVATE LIMITED Mumbai IN	100048889;100089578	CEP 2023-335 - Rev 00	2026/02/18	Valid	18/02/2031	Chemical	2026/02/18	New application\|CEP granted\|18/02/2026
1275	Ursodeoxycholic acid	ZHONGSHAN BELLING BIOTECHNOLOGY CO., LTD. Zhongshan City CN	100039390;100062018	CEP 2018-237 - Rev 02	2026/02/18	Valid		Chemical	2026/02/18	Monograph revision\|CEP granted\|18/02/2026; Renewal\|CEP granted\|10/07/2024; Notification\|Accepted - CEP remains valid\|26/09/2023
579	Aprotinin concentrated solution, Activity: 100 - 136 Ph. Eur. Units of aprotinin activity per mL Bacterial endotoxin free	PENTAPHARM AG Aesch CH	100025404;100052203	CEP 2002-095 - Rev 08	2026/02/18	Valid		Chemical and TSE	2026/02/18	Monograph revision\|CEP granted\|18/02/2026; Monograph revision\|CEP granted\|20/03/2025; Notification\|Accepted - CEP remains valid\|17/07/2023; Transfer of holdership\|CEP granted\|30/06/2023; Notification\|Accepted - CEP remains valid\|04/04/2022; Monograph revision\|CEP granted\|23/02/2022; Minor revision\|Accepted - CEP remains valid\|27/11/2020

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)	-