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
2288	Citalopram hydrobromide, CTP Process	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2012-120 - Rev 05	2025/08/01	Valid		Chemical	2025/08/01	Minor revision\|CEP granted\|01/08/2025; Minor revision\|CEP granted\|11/09/2024; Minor revision\|CEP granted\|17/11/2021
2760	Brimonidine tartrate	SIEGFRIED GRAFTON, INC. Grafton US	100042515;100070251	CEP 2015-265 - Rev 01	2025/08/01	Valid		Chemical	2025/08/01	Notification\|CEP granted\|01/08/2025; Notification\|Accepted - CEP remains valid\|02/05/2024; Notification\|Accepted - CEP remains valid\|04/05/2023; Renewal\|CEP granted\|24/01/2023; Notification\|CEP granted\|27/08/2021
2675	Irinotecan hydrochloride trihydrate	LAURUS LABS LIMITED Hyderabad IN	100011702;100032608	CEP 2019-292 - Rev 03	2025/08/01	Valid	19/10/2026	Chemical	2025/08/01	Minor revision\|CEP granted\|01/08/2025; Minor revision\|Rejected\|23/05/2025; Minor revision\|Accepted - CEP remains valid\|25/11/2024; Minor revision\|CEP granted\|11/12/2023; Minor revision\|CEP granted\|26/01/2023
2258	Olanzapine	SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN	100032307;100078783	CEP 2012-050 - Rev 04	2025/07/31	Valid		Chemical	2025/07/31	Notification\|CEP granted\|31/07/2025; Major revision\|CEP granted\|14/05/2025; Minor revision\|CEP granted\|21/02/2023
1295	Calcifediol monohydrate	FORMOSA LABORATORIES, INC. Taoyuan TW	100011879;100018688	CEP 2019-163 - Rev 03	2025/07/31	Valid	28/10/2026	Chemical	2025/07/31	Minor revision\|CEP granted\|31/07/2025; Minor revision\|CEP granted\|27/08/2024; Notification\|Rejected\|08/07/2024; Administrative procedure\|CEP granted\|16/11/2021
2593	Docetaxel	FUJIAN SOUTH PHARMACEUTICAL CO., LTD. Sanming CN	100012371;100021536	CEP 2016-204 - Rev 05	2025/07/31	Valid		Chemical	2025/07/31	Minor revision\|CEP granted\|31/07/2025; Renewal\|CEP granted\|20/12/2023; Minor revision\|CEP granted\|03/10/2022; Minor revision\|CEP granted\|16/03/2021
1781	Fludarabine phosphate	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2005-257 - Rev 06	2025/07/31	Valid		Chemical	2025/07/31	Minor revision\|CEP granted\|31/07/2025; Minor revision\|CEP granted\|09/04/2024; Notification\|Accepted - CEP remains valid\|09/09/2022; Notification\|CEP granted\|10/11/2021; Notification\|Accepted - CEP remains valid\|25/03/2021
2631	Rosuvastatin calcium	CHROMO LABORATORIES INDIA PRIVATE LIMITED Pashamylaram IN	100038839;100060978	CEP 2022-009 - Rev 02	2025/07/31	Valid	01/06/2028	Chemical	2025/07/31	Minor revision\|CEP granted\|31/07/2025; Minor revision\|CEP granted\|14/05/2024; Notification\|Rejected\|22/03/2024; New application\|CEP granted\|01/06/2023
2338	Mirtazapine	MEGA FINE PHARMA PRIVATE LIMITED Mumbai IN	100011550;100021133	CEP 2024-116 - Rev 00	2025/07/31	Valid	31/07/2030	Chemical	2025/07/31	New application\|CEP granted\|31/07/2025
1076	Bumetanide	MEDILUX LABORATORIES PRIVATE LIMITED Pithampur IN	100023732;100032901	CEP 2024-248 - Rev 00	2025/07/31	Valid	31/07/2030	Chemical	2025/07/31	New application\|CEP granted\|31/07/2025
3139	Brivaracetam	ZHEJIANG TIANYU PHARMACEUTICAL CO., LTD. Taizhou City CN	100012174;100018701	CEP 2025-089 - Rev 00	2025/07/31	Valid	31/07/2030	Chemical	2025/07/31	New application\|CEP granted\|31/07/2025
2541	Quetiapine Fumarate, ID 3871	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2020-234 - Rev 03	2025/07/31	Valid		Chemical	2025/07/31	Renewal\|CEP granted\|31/07/2025; Minor revision\|CEP granted\|19/12/2023; Notification\|CEP granted\|22/02/2022; New application\|CEP granted\|13/11/2020
1524	Gliclazide	BAL PHARMA LIMITED Bengaluru IN	100016398;100041736	CEP 2001-273 - Rev 08	2025/07/30	Valid		Chemical	2025/07/30	Administrative procedure\|CEP granted\|30/07/2025; Notification\|CEP granted\|19/06/2025; Notification\|CEP granted\|21/03/2025; Notification\|CEP granted\|23/10/2023; Minor revision\|CEP granted\|17/04/2023
2015	Ebastine	BAL PHARMA LIMITED Bengaluru IN	100016398;100041736	CEP 2013-051 - Rev 04	2025/07/30	Valid		Chemical	2025/07/30	Administrative procedure\|CEP granted\|30/07/2025; Notification\|CEP granted\|19/06/2025; Notification\|CEP granted\|22/04/2024; Minor revision\|CEP granted\|28/11/2022
333	Heparin sodium	HELM PORTUGAL UNIPESSOAL LDA. Carnaxide PT	100004498;100075893	CEP 2002-012 - Rev 08	2025/07/30	Valid		Chemical	2025/07/30	Notification\|CEP granted\|30/07/2025; Major revision\|CEP granted\|27/11/2024; Monograph revision\|Accepted - CEP remains valid\|19/06/2024; Major revision\|CEP granted\|09/10/2020
1524	Gliclazide, AP	BAL PHARMA LIMITED Bengaluru IN	100016398;100041736	CEP 2013-039 - Rev 04	2025/07/30	Valid		Chemical	2025/07/30	Administrative procedure\|CEP granted\|30/07/2025; Notification\|CEP granted\|23/06/2025; Administrative procedure\|CEP granted\|03/03/2025; Minor revision\|CEP granted\|13/02/2025; Renewal\|CEP granted\|27/08/2020
267	Caffeine	HEBEI GUANGXIANG PHARMACEUTICAL CO. LTD. Cangzhou CN	100048186;100079867	CEP 2024-083 - Rev 01	2025/07/30	Valid	17/06/2030	Chemical	2025/07/30	Administrative procedure\|CEP granted\|30/07/2025; New application\|CEP granted\|17/06/2025
1093	Cyclopentolate hydrochloride	ESTEVE QUIMICA S.A. Barcelona ES	100002266;100056508	CEP 2016-078 - Rev 01	2025/07/30	Valid		Chemical	2025/07/30	Minor revision\|CEP granted\|30/07/2025; Minor revision\|Accepted - CEP remains valid\|11/01/2024; Renewal\|CEP granted\|19/10/2022; Transfer of holdership\|CEP granted\|16/03/2022; Administrative procedure\|CEP granted\|22/07/2020
845	Mebendazole, Form-C, micronised and non-micronised	MSN LIFE SCIENCES PRIVATE LIMITED Medak IN	100018316;100027671	CEP 2018-242 - Rev 02	2025/07/30	Valid		Chemical	2025/07/30	Renewal\|CEP granted\|30/07/2025; Minor revision\|CEP granted\|19/08/2022
1425	Fosfomycin trometamol	NORTHEAST PHARMACEUTICAL GROUP CO. LTD Shenyang CN	100021339;100054155	CEP 2023-201 - Rev 01	2025/07/30	Valid	20/05/2030	Chemical	2025/07/30	Notification\|CEP granted\|30/07/2025; New application\|CEP granted\|20/05/2025

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)	-