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
2866	Gefitinib	ZHEJIANG JIUZHOU PHARMACEUTICAL CO. LTD. Taizhou CN	100011841;100018560	CEP 2018-236 - Rev 02	2025/06/05	Valid		Chemical	2025/06/05	Renewal\|CEP granted\|05/06/2025; Minor revision\|CEP granted\|02/02/2022; Minor revision\|Accepted - CEP remains valid\|19/08/2021
333	Heparin sodium, For parenteral preparations	YANTAI DONGCHENG BIOCHEMICALS CO. LTD. Yantai CN	100022810;100052422	CEP 2003-197 - Rev 11	2025/06/05	Valid		Chemical	2026/01/21	Monograph revision\|Accepted - CEP remains valid\|21/01/2026; Major revision\|CEP granted\|05/06/2025; Monograph revision\|Accepted - CEP remains valid\|13/06/2024; Major revision\|CEP granted\|28/09/2022; Major revision\|CEP granted\|21/01/2022
1699	Mesalazine	BEC CHEMICALS PRIVATE LIMITED Mumbai IN	100016436;100025221	CEP 2011-100 - Rev 01	2025/06/05	Valid		Chemical	2025/06/05	Minor revision\|CEP granted\|05/06/2025; Minor revision\|Accepted - CEP remains valid\|31/07/2024; Minor revision\|Accepted - CEP remains valid\|18/04/2023; Minor revision\|Accepted - CEP remains valid\|09/10/2020
925	Levomepromazine maleate	COHANCE LIFESCIENCES LIMITED Mumbai IN	100011755;100090273	CEP 2018-144 - Rev 05	2025/06/05	Valid		Chemical	2025/06/05	Minor revision\|CEP granted\|05/06/2025; Renewal\|Accepted - CEP remains valid\|24/03/2025; Notification\|CEP granted\|10/07/2024; Minor revision\|Accepted - CEP remains valid\|09/04/2024; Monograph revision\|CEP granted\|09/08/2023; Notification\|CEP granted\|12/02/2021; Minor revision\|CEP granted\|07/08/2020
1651	Clarithromycin, Form-II (Process-II)	SYNTHIMED LABS PRIVATE LIMITED Derabassi IN	100052287;100092080	CEP 2024-435 - Rev 01	2025/06/05	Valid	11/03/2030	Chemical	2025/06/05	Minor revision\|CEP granted\|05/06/2025; New application\|CEP granted\|11/03/2025
396	Hydrogen peroxide solution (30 per cent)	ARKEMA FRANCE Puteaux FR	100049819;100096345	CEP 2024-402 - Rev 00	2025/06/05	Valid	05/06/2030	Chemical	2025/06/05	New application\|CEP granted\|05/06/2025
1470	Simeticone, SILFAR S 188	WACKER CHEMIE AG Munich DE	100020886;100093340	CEP 2020-264 - Rev 01	2025/06/05	Valid		Chemical	2025/06/06	Renewal\|CEP granted\|06/06/2025; Notification\|Accepted - CEP remains valid\|02/09/2021; New application\|CEP granted\|23/10/2020
2630	Rivastigmine hydrogen tartrate	SHODHANA LABORATORIES PRIVATE LIMITED Hyderabad IN	100021550;100030244	CEP 2019-066 - Rev 02	2025/06/05	Valid		Chemical	2025/06/05	Renewal\|CEP granted\|05/06/2025; Minor revision\|CEP granted\|31/03/2021
2617	Aripiprazole, Form II	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2018-267 - Rev 03	2025/06/05	Valid		Chemical	2025/06/05	Renewal\|CEP granted\|05/06/2025; Major revision\|CEP granted\|17/02/2023; Notification\|CEP granted\|23/09/2021; Monograph revision\|Accepted - CEP remains valid\|13/04/2021
454	Acetazolamide, Process B	NAKODA CHEMICALS LIMITED Hyderabad IN	100018043;100026836	CEP 2010-352 - Rev 02	2025/06/04	Valid		Chemical	2025/06/04	Minor revision\|CEP granted\|04/06/2025; Minor revision\|Accepted - CEP remains valid\|16/06/2023; Notification\|CEP granted\|13/05/2022
2776	Nicardipine hydrochloride	MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN	100011732;100018657	CEP 2024-005 - Rev 00	2025/06/04	Valid	04/06/2030	Chemical	2025/06/04	New application\|CEP granted\|04/06/2025
2813	Mycophenolate sodium	RAKSHIT PHARMACEUTICALS LIMITED Anakapalli District IN	100039283;100061839	CEP 2023-092 - Rev 00	2025/06/04	Valid	04/06/2030	Chemical	2025/06/04	New application\|CEP granted\|04/06/2025
454	Acetazolamide	NAKODA CHEMICALS LIMITED Hyderabad IN	100018043;100026836	CEP 2001-387 - Rev 06	2025/06/04	Valid		Chemical	2025/06/04	Minor revision\|CEP granted\|04/06/2025; Minor revision\|Accepted - CEP remains valid\|16/06/2023; Notification\|CEP granted\|13/05/2022
2173	Gabapentin	ANJAN DRUG PRIVATE LIMITED Gummidipoondi IN	100023458;100079845	CEP 2013-164 - Rev 02	2025/06/04	Valid		Chemical	2025/06/04	Major revision\|CEP granted\|04/06/2025; Notification\|Accepted - CEP remains valid\|22/12/2022; Notification\|CEP granted\|30/03/2022; Renewal\|CEP granted\|16/10/2020
1734	Terbinafine hydrochloride	OLON S.P.A. Rodano IT	100012085;100019537	CEP 2017-272 - Rev 04	2025/06/04	Valid		Chemical	2025/06/04	Renewal\|CEP granted\|04/06/2025; Minor revision\|CEP granted\|03/11/2022; Minor revision\|CEP granted\|08/02/2022; Minor revision\|CEP granted\|02/02/2021
546	Chlortalidone	CHROMO LABORATORIES INDIA PRIVATE LIMITED Pashamylaram IN	100038839;100060978	CEP 2018-175 - Rev 03	2025/06/03	Valid		Chemical	2025/06/03	Renewal\|CEP granted\|03/06/2025; Notification\|CEP granted\|24/05/2023; Major revision\|CEP granted\|26/04/2023; Monograph revision\|Accepted - CEP remains valid\|24/06/2022
1491	Amlodipine besilate	KOPRAN RESEARCH LABORATORIES LIMITED Mumbai IN	100033667;100081898	CEP 2021-242 - Rev 00	2025/06/03	Valid	03/06/2030	Chemical	2025/06/03	New application\|CEP granted\|03/06/2025
3014	Rotigotine, Form II	NEULAND LABORATORIES LIMITED Hyderabad IN	100011545;100062134	CEP 2020-010 - Rev 04	2025/06/03	Valid	25/05/2026	Chemical	2025/06/03	Minor revision\|CEP granted\|03/06/2025; Notification\|CEP granted\|29/03/2023; Minor revision\|CEP granted\|27/04/2022; Notification\|CEP granted\|08/09/2021; New application\|CEP granted\|25/05/2021
1520	Foscarnet sodium hexahydrate	EMCURE PHARMACEUTICALS LIMITED Pune IN	100011677;100022690	CEP 2021-342 - Rev 02	2025/06/03	Valid	05/04/2027	Chemical	2025/06/03	Minor revision\|CEP granted\|03/06/2025; Notification\|Rejected\|15/04/2025; Minor revision\|CEP granted\|22/05/2023; New application\|CEP granted\|05/04/2022
77	Dapsone	MEDILUX LABORATORIES PRIVATE LIMITED Pithampur IN	100023732;100032901	CEP 2023-195 - Rev 00	2025/06/03	Valid	03/06/2030	Chemical	2025/07/21	Notification\|Accepted - CEP remains valid\|21/07/2025; New application\|CEP granted\|03/06/2025

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)	-