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
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
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
3136	Saxagliptin monohydrate	SYNTHIMED LABS PRIVATE LIMITED Derabassi IN	100052287;100092080	CEP 2024-432 - Rev 00	2026/02/03	Valid	03/02/2031	Chemical	2026/02/03	New application\|CEP granted\|03/02/2026
821	Estradiol hemihydrate	ARESKO LIFE SCIENCES PRIVATE LIMITED Ramnagar IN	100051467;100090218	CEP 2024-230 - Rev 00	2026/02/03	Valid	03/02/2031	Chemical	2026/02/03	New application\|CEP granted\|03/02/2026
2866	Gefitinib, Micronised	NATCO PHARMA LIMITED Hyderabad IN	100011544;100018604	CEP 2017-244 - Rev 03	2026/02/02	Valid		Chemical	2026/02/02	Minor revision\|CEP granted\|02/02/2026; Minor revision\|CEP granted\|07/02/2024; Renewal\|CEP granted\|21/11/2023
675	Metronidazole	CORDEN PHARMA BERGAMO S.P.A. Treviglio IT	100018132;100026914	CEP 1995-052 - Rev 03	2026/02/02	Valid		Chemical	2026/02/02	Notification\|CEP granted\|02/02/2026
2777	Pregabalin	CHROMO LABORATORIES INDIA PRIVATE LIMITED Pashamylaram IN	100038839;100060978	CEP 2023-298 - Rev 00	2026/02/02	Valid	02/02/2031	Chemical	2026/02/02	New application\|CEP granted\|02/02/2026
1275	Ursodeoxycholic acid	SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN	100044578;100073706	CEP 2022-275 - Rev 01	2026/02/02	Valid	30/07/2029	Chemical	2026/03/10	Minor revision\|Rejected\|10/03/2026; Monograph revision\|CEP granted\|02/02/2026; New application\|CEP granted\|30/07/2024
898	Dipotassium clorazepate monohydrate	HONOUR LAB LIMITED Hyderabad IN	100011891;100097835	CEP 2024-134 - Rev 00	2026/02/02	Valid	02/02/2031	Chemical	2026/02/02	New application\|CEP granted\|02/02/2026
1491	Amlodipine besilate, Process II	CIPLA LIMITED Mumbai IN	100006004;100018147	CEP 2015-140 - Rev 02	2026/02/02	Valid		Chemical	2026/02/02	Monograph revision\|CEP granted\|02/02/2026; Minor revision\|CEP granted\|02/05/2025; Minor revision\|Accepted - CEP remains valid\|24/04/2023; Renewal\|CEP granted\|16/09/2020
1977	Fluvoxamine maleate	LAKE CHEMICALS PRIVATE LIMITED Bengaluru IN	100012055;100053935	CEP 2024-047 - Rev 00	2026/02/02	Valid	02/02/2031	Chemical	2026/02/02	New application\|CEP granted\|02/02/2026

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)	-