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
2577	Oxcarbazepine, Micronised and non-micronised	HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO., LTD. Ezhou CN	100015482;100024200	CEP 2018-165 - Rev 05	2026/02/04	Valid		Chemical	2026/02/04	Minor revision\|CEP granted\|04/02/2026; Administrative procedure\|CEP granted\|02/12/2024; Minor revision\|CEP granted\|21/11/2024; Renewal\|CEP granted\|03/10/2024; Minor revision\|CEP granted\|07/07/2023
942	Omeprazole, Micronised and sieved grade	ESTEVE QUIMICA S.A. Barcelona ES	100002266;100056508	CEP 1998-145 - Rev 12	2026/02/04	Valid		Chemical	2026/02/04	Notification\|CEP granted\|04/02/2026; Minor revision\|CEP granted\|12/07/2024; Notification\|Accepted - CEP remains valid\|20/04/2023; Transfer of holdership\|CEP granted\|16/03/2022; Notification\|Accepted - CEP remains valid\|04/11/2021; Notification\|CEP granted\|24/03/2020
2932	Rivaroxaban	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2023-231 - Rev 02	2026/02/04	Valid	19/11/2029	Chemical	2026/02/04	Administrative procedure\|CEP granted\|04/02/2026; Minor revision\|CEP granted\|26/01/2026; Notification\|Rejected\|17/12/2025; Minor revision\|Accepted - CEP remains valid\|10/07/2025; New application\|CEP granted\|19/11/2024
859	Pyrazinamide	ANUH PHARMA LIMITED Mumbai IN	100021566;100030259	CEP 2005-059 - Rev 04	2026/02/04	Valid		Chemical	2026/02/04	Notification\|CEP granted\|04/02/2026; Minor revision\|CEP granted\|30/04/2020
401	Levothyroxine sodium	MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN	100011732;100023530	CEP 2025-250 - Rev 00	2026/02/04	Valid	04/02/2031	Chemical	2026/02/04	New application\|CEP granted\|04/02/2026
2756	Amorolfine hydrochloride	ZHEJIANG CDMO PHARMACEUTICAL CO., LTD Jinhua CN	100051857;100091157	CEP 2024-449 - Rev 00	2026/02/04	Valid	04/02/2031	Chemical	2026/02/04	New application\|CEP granted\|04/02/2026
2931	Sorafenib tosilate	KINHOO PHARMACEUTICAL CO., LTD. Zhuhai CN	100050160;100087573	CEP 2024-398 - Rev 00	2026/02/04	Valid	04/02/2031	Chemical	2026/02/04	New application\|CEP granted\|04/02/2026
1681	Tramadol hydrochloride, Process-III	SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN	100008538;100018201	CEP 2025-016 - Rev 01	2026/02/04	Valid	09/05/2030	Chemical	2026/02/04	Minor revision\|CEP granted\|04/02/2026; New application\|CEP granted\|09/05/2025
2773	Memantine hydrochloride, Form-I	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2025-110 - Rev 00	2026/02/04	Valid	04/02/2031	Chemical	2026/02/04	New application\|CEP granted\|04/02/2026
2804	Sulfobutylbetadex sodium	SHANDONG BINZHOU ZHIYUAN BIOTECHNOLOGY CO., LTD Binzhou City CN	100050073;100087418	CEP 2024-406 - Rev 00	2026/02/04	Valid	04/02/2031	Chemical	2026/02/04	New application\|CEP granted\|04/02/2026
851	Pentoxifylline	HIKAL LIMITED Bengaluru IN	100014769;100023445	CEP 2005-131 - Rev 05	2026/02/03	Valid		Chemical	2026/02/03	Minor revision\|CEP granted\|03/02/2026; Major revision\|CEP granted\|07/11/2023; Notification\|CEP granted\|14/09/2022; Notification\|CEP granted\|24/06/2021
698	Warfarin sodium	TARO PHARMACEUTICAL INDUSTRIES, LTD. Haifa IL	100004559;100001120	CEP 2001-285 - Rev 06	2026/02/03	Valid		Chemical	2026/02/03	Minor revision\|CEP granted\|03/02/2026; Minor revision\|Accepted - CEP remains valid\|21/12/2020
2060	Codergocrine mesilate	TAPI CZECH INDUSTRIES S.R.O. Opava CZ	100051642;100090678	CEP 2009-143 - Rev 04	2026/02/03	Valid		Chemical	2026/02/03	Monograph revision\|CEP granted\|03/02/2026; Notification\|CEP granted\|13/01/2025; Monograph revision\|CEP granted\|14/04/2023
1491	Amlodipine besilate, Process II	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2016-077 - Rev 02	2026/02/03	Valid		Chemical	2026/02/03	Monograph revision\|CEP granted\|03/02/2026; Notification\|CEP granted\|16/04/2025; Minor revision\|Accepted - CEP remains valid\|03/02/2023; Minor revision\|Accepted - CEP remains valid\|30/08/2022; Renewal\|CEP granted\|29/10/2021
1199	Dipyridamole	COHANCE LIFESCIENCES LIMITED Mumbai IN	100011755;100090273	CEP 2014-148 - Rev 02	2026/02/03	Valid		Chemical	2026/02/03	Major revision\|CEP granted\|03/02/2026; Notification\|CEP granted\|16/12/2022; Minor revision\|Rejected\|16/09/2022; Renewal\|CEP granted\|26/02/2021; Minor revision\|CEP granted\|15/05/2020
335	Hydrocortisone	ZHEJIANG ACINOVA PHARMACEUTICAL CO., LTD. Taizhou CN	100054484;100096546	CEP 2017-208 - Rev 03	2026/02/03	Valid		Chemical	2026/02/03	Major revision\|CEP granted\|03/02/2026; Notification\|CEP granted\|27/05/2025; Renewal\|CEP granted\|19/07/2024
2857	Trazodone hydrochloride, Process-II, Milled/Unmilled	INTAS PHARMACEUTICALS LIMITED Ahmedabad IN	100011529;100023432	CEP 2025-141 - Rev 01	2026/02/03	Valid	13/11/2030	Chemical	2026/02/03	Minor revision\|CEP granted\|03/02/2026; New application\|CEP granted\|13/11/2025
730	Naphazoline Hydrochloride	PRECISE BIOPHARMA PRIVATE LIMITED Mumbai IN	100052889;100095902	CEP 2025-444 - Rev 00	2026/02/03	Valid	03/02/2031	Chemical	2026/02/03	New application\|CEP granted\|03/02/2026
475	Chlorpromazine hydrochloride, Micronised and non-micronised	MAITHRI LABORATORIES PRIVATE LIMITED Gaddapotharam Village IN	100013041;100021615	CEP 2021-018 - Rev 04	2026/02/03	Valid	01/08/2027	Chemical	2026/02/03	Minor revision\|CEP granted\|03/02/2026; Minor revision\|CEP granted\|11/03/2025; Notification\|CEP granted\|15/02/2023; Administrative procedure\|CEP granted\|30/08/2022; New application\|CEP granted\|01/08/2022
2675	Irinotecan hydrochloride trihydrate	JIANGSU XIDI PHARMACEUTICALS CO., LTD Qidong CN	100045987;100075857	CEP 2024-311 - Rev 00	2026/02/03	Valid	03/02/2031	Chemical	2026/02/03	New application\|CEP granted\|03/02/2026

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)	-