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
525	Propylthiouracil	NANTONG JINGHUA PHARMACEUTICAL CO., LTD. Nantong CN	100018246;100052237	CEP 2023-467 - Rev 01	2025/10/16	Valid	01/04/2030	Chemical	2025/10/16	Monograph revision\|CEP granted\|16/10/2025; New application\|CEP granted\|01/04/2025
312	Betamethasone	MSD EUROPE BELGIUM Watermael-Boitsfort BE	100049238;100083482	CEP 2017-092 - Rev 02	2025/10/16	Valid		Chemical	2025/10/16	Administrative procedure\|CEP granted\|16/10/2025; Minor revision\|CEP granted\|25/09/2025; Renewal\|CEP granted\|12/12/2022
1765	Salmeterol xinafoate	INDUSTRIALE CHIMICA S.R.L. Saronno IT	100011692;100020331	CEP 2013-107 - Rev 02	2025/10/16	Valid		Chemical	2025/10/16	Notification\|CEP granted\|16/10/2025; Notification\|Rejected\|02/10/2025; Notification\|CEP granted\|18/03/2022
968	Aciclovir, Site Khazipally	AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN	100046306;100076393	CEP 2021-274 - Rev 01	2025/10/16	Valid	07/10/2026	Chemical	2025/10/16	Minor revision\|CEP granted\|16/10/2025; New application\|CEP granted\|07/10/2021
729	Naloxone hydrochloride dihydrate, Process II	NORAMCO, LLC. Wilmington US	100048651;100080628	CEP 2025-340 - Rev 00	2025/10/15	Valid	15/10/2030	Chemical	2025/10/15	New application\|CEP granted\|15/10/2025
2779	Solifenacin succinate, Process 2	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2024-429 - Rev 02	2025/10/15	Valid	12/12/2029	Chemical	2025/10/15	Notification\|CEP granted\|15/10/2025; Notification\|CEP granted\|12/03/2025; New application\|CEP granted\|12/12/2024
1322	Fenofibrate	OLON S.P.A. Rodano IT	100012085;100019537	CEP 2003-260 - Rev 06	2025/10/15	Valid		Chemical	2025/10/15	Minor revision\|CEP granted\|15/10/2025; Minor revision\|CEP granted\|29/03/2022; Minor revision\|CEP granted\|10/02/2021
1792	Nicotine resinate, Nicotine content 15% with glycerol 22.0-26.0%	FERTIN PHARMA A/S Vejle DK	100000411;100003193	CEP 2012-226 - Rev 01	2025/10/15	Valid		Chemical	2025/10/15	Notification\|CEP granted\|15/10/2025; Notification\|Accepted - CEP remains valid\|09/07/2025; Notification\|Accepted - CEP remains valid\|04/08/2023
2089	Acarbose	CKD BIO CORPORATION Ansan-si KR	100018976;100029257	CEP 2007-252 - Rev 03	2025/10/14	Valid		Chemical	2025/10/14	Minor revision\|CEP granted\|14/10/2025; Notification\|Accepted - CEP remains valid\|06/11/2023; Notification\|Accepted - CEP remains valid\|30/01/2023; Notification\|Accepted - CEP remains valid\|04/04/2022; Notification\|Accepted - CEP remains valid\|29/09/2020
1662	Tyrothricin	XELLIA PHARMACEUTICALS LTD. Budapest X HU	100012234;100020635	CEP 2013-205 - Rev 03	2025/10/14	Valid		Chemical	2025/10/14	Major revision\|CEP granted\|14/10/2025; Minor revision\|Accepted - CEP remains valid\|12/02/2024; Notification\|Accepted - CEP remains valid\|05/01/2023; Major revision\|CEP granted\|20/12/2021; Administrative procedure\|CEP granted\|12/03/2021; Notification\|Accepted - CEP remains valid\|01/03/2021
601	Dimenhydrinate	CHEMISCHE FABRIK BERG GMBH Bitterfeld-Wolfen DE	100014200;100020038	CEP 2000-235 - Rev 06	2025/10/14	Valid		Chemical	2025/10/14	Minor revision\|CEP granted\|14/10/2025; Notification\|CEP granted\|13/01/2022; Minor revision\|Accepted - CEP remains valid\|31/05/2021; Minor revision\|Accepted - CEP remains valid\|15/12/2020; Minor revision\|Rejected\|03/12/2020
803	Amiodarone hydrochloride	PMC ISOCHEM Vert Le Petit FR	100011861;100020972	CEP 1997-090 - Rev 12	2025/10/14	Valid		Chemical	2025/10/14	Administrative procedure\|CEP granted\|14/10/2025; Monograph revision\|Accepted - CEP remains valid\|19/09/2025; Minor revision\|CEP granted\|17/04/2024; Notification\|CEP granted\|23/11/2022
309	Acetylsalicylic acid	BAYER HISPANIA, S.L. Langreo ES	100000073;100009552	CEP 2001-292 - Rev 05	2025/10/14	Valid		Chemical	2025/10/14	Notification\|CEP granted\|14/10/2025; Notification\|Accepted - CEP remains valid\|17/06/2025; Minor revision\|Accepted - CEP remains valid\|29/11/2023; Notification\|Accepted - CEP remains valid\|22/04/2022
1084	Cetirizine dihydrochloride	CIPLA LIMITED Mumbai IN	100006004;100018147	CEP 2000-081 - Rev 08	2025/10/14	Valid		Chemical	2025/10/14	Minor revision\|CEP granted\|14/10/2025; Notification\|Accepted - CEP remains valid\|26/04/2022
3095	Dabigatran etexilate mesilate, Micronised	KRKA TOVARNA ZDRAVIL D.D. NOVO MESTO Novo mesto SI	100000627;100009540	CEP 2024-152 - Rev 00	2025/10/14	Valid	14/10/2030	Chemical	2025/10/14	New application\|CEP granted\|14/10/2025
1280	Zolpidem tartrate, Site-II	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2020-320 - Rev 03	2025/10/14	Valid		Chemical	2025/10/14	Renewal\|CEP granted\|14/10/2025; Notification\|CEP granted\|24/01/2024; Minor revision\|CEP granted\|22/09/2022; New application\|CEP granted\|13/01/2021
331	Gentamicin sulfate	FUAN PHARMACEUTICAL GROUP YANTAI JUSTAWARE PHARMACEUTICAL CO., LTD. Yantai CN	100038871;100061089	CEP 2024-008 - Rev 00	2025/10/14	Valid	14/10/2030	Chemical	2025/10/14	New application\|CEP granted\|14/10/2025
2296	Pantoprazole sodium sesquihydrate, Process III	IOL CHEMICALS AND PHARMACEUTICALS LTD Ludhiana IN	100017919;100037377	CEP 2025-303 - Rev 00	2025/10/14	Valid	14/10/2030	Chemical	2025/10/14	New application\|CEP granted\|14/10/2025
2015	Ebastine, Process-II	MICRO LABS LIMITED Bengaluru IN	100017819;100077269	CEP 2024-268 - Rev 00	2025/10/14	Valid	14/10/2030	Chemical	2025/10/14	New application\|CEP granted\|14/10/2025
2675	Irinotecan hydrochloride trihydrate, Process-2	LAURUS LABS LIMITED Hyderabad IN	100011702;100032608	CEP 2025-394 - Rev 00	2025/10/14	Valid	14/10/2030	Chemical	2025/10/14	New application\|CEP granted\|14/10/2025

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)	-