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
1108	Indapamide, Micronised	KRKA TOVARNA ZDRAVIL D.D. NOVO MESTO Novo mesto SI	100000627;100009540	CEP 2024-179 - Rev 00	2025/06/13	Valid	13/06/2030	Chemical	2025/12/15	Minor revision\|Accepted - CEP remains valid\|15/12/2025; New application\|CEP granted\|13/06/2025
1292	Amphotericin B, Intended For Use in the Manufacture of Parenteral Preparations	Asence Pharma Private Limited Vadodara IN	100023319;100088414	CEP 2024-118 - Rev 00	2025/06/13	Valid	13/06/2030	Chemical	2025/06/13	New application\|CEP granted\|13/06/2025
1995	Sodium glycerophosphate, hydrated	MACCO ORGANIQUES, S.R.O. Bruntál CZ	100017613;100026377	CEP 2024-320 - Rev 00	2025/06/12	Valid	12/06/2030	Chemical	2025/06/12	New application\|CEP granted\|12/06/2025
721	Ibuprofen, IPA route	SMS PHARMACEUTICALS LIMITED Hyderabad IN	100011780;100061058	CEP 2020-414 - Rev 02	2025/06/12	Valid	21/07/2027	Chemical	2025/11/10	Minor revision\|Accepted - CEP remains valid\|10/11/2025; Minor revision\|CEP granted\|12/06/2025; Minor revision\|CEP granted\|25/03/2024; Minor revision\|Accepted - CEP remains valid\|05/04/2023; New application\|CEP granted\|21/07/2022
2589	Abacavir sulfate, Form-II	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2016-090 - Rev 01	2025/06/12	Valid		Chemical	2025/06/12	Minor revision\|CEP granted\|12/06/2025; Renewal\|CEP granted\|27/01/2023; Minor revision\|Accepted - CEP remains valid\|13/07/2021; Minor revision\|CEP granted\|25/03/2021; Notification\|Accepted - CEP remains valid\|17/06/2020
1386	Albendazole	RAKSHIT DRUGS PRIVATE LIMITED Hyderabad IN	100011756;100060531	CEP 2023-268 - Rev 00	2025/06/12	Valid	12/06/2030	Chemical	2025/06/12	New application\|CEP granted\|12/06/2025
2594	Duloxetine hydrochloride	ALKEM LABORATORIES LIMITED Mumbai IN	100005554;100010367	CEP 2024-139 - Rev 00	2025/06/12	Valid	12/06/2030	Chemical	2025/06/12	New application\|CEP granted\|12/06/2025
260	Amoxicillin trihydrate, Toansa, India: powder grade, powder extra dry grade, compacted grade A, compacted HBD grade, compacted grade A extra dry, compacted grade P, compacted direct compression grade, powder grade C and powder grade E	CENTRIENT PHARMACEUTICALS NETHERLANDS B.V. Delft NL	100002351;100005259	CEP 2007-226 - Rev 05	2025/06/12	Valid		Chemical	2025/06/12	Minor revision\|CEP granted\|12/06/2025; Minor revision\|CEP granted\|21/02/2025; Minor revision\|Accepted - CEP remains valid\|14/11/2023; Minor revision\|Accepted - CEP remains valid\|09/05/2022; Minor revision\|Accepted - CEP remains valid\|14/02/2022; Minor revision\|Accepted - CEP remains valid\|06/07/2020
2089	Acarbose	ZHEJIANG HISUN PHARMACEUTICAL CO., LTD. Taizhou City CN	100011825;100018687	CEP 2006-144 - Rev 02	2025/06/11	Valid		Chemical	2025/06/11	Minor revision\|CEP granted\|11/06/2025; Administrative procedure\|CEP granted\|17/03/2021
1734	Terbinafine hydrochloride	CIPLA LIMITED Mumbai IN	100006004;100018147	CEP 2007-028 - Rev 05	2025/06/11	Valid		Chemical	2025/06/11	Minor revision\|CEP granted\|11/06/2025; Minor revision\|CEP granted\|18/01/2021
1180	Buprenorphine	TAPI CZECH INDUSTRIES S.R.O. Opava CZ	100051642;100090678	CEP 2008-041 - Rev 05	2025/06/11	Valid		Chemical	2025/06/11	Minor revision\|CEP granted\|11/06/2025; Minor revision\|CEP granted\|01/08/2024; Minor revision\|CEP granted\|23/05/2022; Notification\|Rejected\|21/12/2021; Minor revision\|CEP granted\|02/07/2021
922	Ketoprofen	BEC CHEMICALS PRIVATE LIMITED Mumbai IN	100016436;100025221	CEP 2007-167 - Rev 04	2025/06/11	Valid		Chemical	2025/12/17	Notification\|Accepted - CEP remains valid\|17/12/2025; Minor revision\|CEP granted\|11/06/2025; Minor revision\|CEP granted\|17/02/2025; Monograph revision\|Accepted - CEP remains valid\|27/11/2024; Minor revision\|Accepted - CEP remains valid\|06/09/2024; Minor revision\|CEP granted\|28/04/2023; Minor revision\|Accepted - CEP remains valid\|18/01/2022; Minor revision\|Accepted - CEP remains valid\|15/09/2020
2918	Everolimus, 2.0% BHT - PROCESS II	FARMHISPANIA S.A. Montmeló ES	100011645;100022190	CEP 2024-548 - Rev 00	2025/06/11	Valid	11/06/2030	Chemical	2025/06/11	New application\|CEP granted\|11/06/2025
989	Cefotaxime sodium, Sterile	SHANDONG ANHONG PHARMACEUTICAL CO., LTD. Dezhou CN	100014777;100050265	CEP 2024-318 - Rev 00	2025/06/11	Valid	11/06/2030	Chemical	2025/06/11	New application\|CEP granted\|11/06/2025
2600	Olmesartan medoxomil	EUROAPI HUNGARY Ltd. Budapest HU	100039256;100061798	CEP 2013-105 - Rev 04	2025/06/10	Valid		Chemical	2025/06/10	Minor revision\|CEP granted\|10/06/2025; Minor revision\|CEP granted\|26/03/2024; Notification\|Rejected\|13/02/2024; Minor revision\|Accepted - CEP remains valid\|10/10/2022; Notification\|Rejected\|02/03/2022; Notification\|CEP granted\|14/12/2021; Notification\|Accepted - CEP remains valid\|24/08/2021
1615	Finasteride, Micronised and non-micronised	HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO., LTD. Ezhou City CN	100015482;100024200	CEP 2013-238 - Rev 01	2025/06/10	Valid		Chemical	2025/06/10	Minor revision\|CEP granted\|10/06/2025
1491	Amlodipine besilate	DR. REDDY'S LABORATORIES LIMITED Hyderabad IN	100003991;100000217	CEP 2003-007 - Rev 07	2025/06/06	Valid		Chemical	2025/06/06	Minor revision\|CEP granted\|06/06/2025
2787	Esomeprazole magnesium dihydrate	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2014-333 - Rev 03	2025/06/06	Valid		Chemical	2025/06/06	Notification\|CEP granted\|06/06/2025; Minor revision\|CEP granted\|08/01/2025; Notification\|CEP granted\|07/03/2023; Renewal\|CEP granted\|26/04/2022; Minor revision\|CEP granted\|11/03/2020
533	Triamcinolone acetonide	SWATI SPENTOSE PRIVATE LIMITED Mumbai IN	100021605;100052219	CEP 2022-255 - Rev 00	2025/06/06	Valid	06/06/2030	Chemical	2025/06/06	New application\|CEP granted\|06/06/2025
1519	Flurbiprofen	WISDOM PHARMACEUTICAL CO., LTD. Haimen CN	100014837;100023467	CEP 2024-024 - Rev 00	2025/06/06	Valid	06/06/2030	Chemical	2025/06/06	New application\|CEP granted\|06/06/2025

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)	-