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
11	Benzocaine, Standard and micronised	CHANGZHOU SUNLIGHT PHARMACEUTICAL CO., LTD. Benniu Town CN	100019106;100051966	CEP 2004-008 - Rev 07	2026/02/11	Valid		Chemical	2026/02/11	Minor revision\|CEP granted\|11/02/2026; Minor revision\|Accepted - CEP remains valid\|05/08/2025; Minor revision\|Accepted - CEP remains valid\|18/03/2024; Minor revision\|Accepted - CEP remains valid\|26/09/2023; Minor revision\|Accepted - CEP remains valid\|01/06/2023; Minor revision\|Accepted - CEP remains valid\|06/12/2022; Minor revision\|Accepted - CEP remains valid\|04/11/2020; Minor revision\|CEP granted\|15/06/2020
2570	Desloratadine	VASUDHA PHARMA CHEM LIMITED Hyderabad IN	100011811;100018603	CEP 2014-310 - Rev 03	2026/02/11	Valid		Chemical	2026/02/11	Minor revision\|CEP granted\|11/02/2026; Notification\|CEP granted\|30/01/2023; Notification\|CEP granted\|22/12/2021; Renewal\|CEP granted\|17/09/2020
375	Carbon dioxide	SOCIEDAD ESPANOLA DE CARBUROS METALICOS S.A. Cornella de Llobregat ES	100003675;100011298	CEP 2019-254 - Rev 01	2026/02/11	Valid		Chemical	2026/02/11	Renewal\|CEP granted\|11/02/2026
729	Naloxone hydrochloride dihydrate	SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBH Minden DE	100012159;100092939	CEP 2011-126 - Rev 03	2026/02/11	Valid		Chemical	2026/02/11	Notification\|CEP granted\|11/02/2026; Minor revision\|CEP granted\|10/07/2024; Minor revision\|Accepted - CEP remains valid\|18/09/2020
2751	Valaciclovir hydrochloride hydrate, Micronised and non-micronised	AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN	100046306;100076393	CEP 2020-059 - Rev 04	2026/02/11	Valid		Chemical	2026/02/11	Renewal\|CEP granted\|11/02/2026; Minor revision\|CEP granted\|25/07/2025; Minor revision\|CEP granted\|25/03/2025; Minor revision\|CEP granted\|17/02/2022; New application\|CEP granted\|19/02/2021
2932	Rivaroxaban	NOSCH LABS PRIVATE LIMITED Hyderabad IN	100020550;100089573	CEP 2022-110 - Rev 01	2026/02/11	Valid	25/06/2029	Chemical	2026/02/11	Notification\|CEP granted\|11/02/2026; New application\|CEP granted\|25/06/2024
2578	Tizanidine hydrochloride	UNICHEM LABORATORIES LIMITED Mumbai IN	100005397;100093080	CEP 2024-473 - Rev 00	2026/02/11	Valid	11/02/2031	Chemical	2026/02/11	New application\|CEP granted\|11/02/2026
1711	Buspirone hydrochloride	COHANCE LIFESCIENCES LIMITED Mumbai IN	100011755;100090273	CEP 2025-096 - Rev 00	2026/02/11	Valid	11/02/2031	Chemical	2026/02/11	New application\|CEP granted\|11/02/2026
1425	Fosfomycin trometamol	ERCROS S.A. Aranjuez ES	100016091;100024873	CEP 2024-191 - Rev 00	2026/02/11	Valid	11/02/2031	Chemical	2026/02/11	New application\|CEP granted\|11/02/2026
2420	Tiotropium bromide monohydrate	SCL LIFESCIENCES LIMITED Sahibzada Ajit Singh Nagar IN	100011774;100018647	CEP 2025-365 - Rev 00	2026/02/11	Valid	11/02/2031	Chemical	2026/02/11	New application\|CEP granted\|11/02/2026
312	Betamethasone	SHANDONG SIRUI PHARMACEUTICAL CO., LTD. Heze CN	100049295;100083729	CEP 2024-446 - Rev 00	2026/02/11	Valid	11/02/2031	Chemical	2026/02/11	New application\|CEP granted\|11/02/2026
2465	Irbesartan	VERDANT LIFE SCIENCES PRIVATE LIMITED Anakapalli IN	100048776;100081115	CEP 2023-281 - Rev 00	2026/02/11	Valid	11/02/2031	Chemical	2026/02/11	New application\|CEP granted\|11/02/2026
72	Cholecalciferol	DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH	100053293;100094111	CEP 2009-050 - Rev 05	2026/02/10	Valid		Chemical and TSE	2026/02/10	Notification\|CEP granted\|10/02/2026; Notification\|CEP granted\|21/07/2025; Minor revision\|CEP granted\|06/12/2024; Minor revision\|CEP granted\|20/03/2024
931	Metformin Hydrochloride	AARTI DRUGS LIMITED Mumbai IN	100014953;100023652	CEP 2015-250 - Rev 01	2026/02/10	Valid		Chemical	2026/02/10	Minor revision\|CEP granted\|10/02/2026; Notification\|Rejected\|05/01/2026; Minor revision\|Accepted - CEP remains valid\|19/12/2024; Renewal\|CEP granted\|18/07/2022; Monograph revision\|Accepted - CEP remains valid\|30/03/2020
2019	Perindopril tert-butylamine	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2008-009 - Rev 06	2026/02/10	Valid		Chemical	2026/02/10	Minor revision\|CEP granted\|10/02/2026; Minor revision\|CEP granted\|17/01/2024; Minor revision\|Accepted - CEP remains valid\|18/01/2023; Minor revision\|Accepted - CEP remains valid\|12/03/2021; Minor revision\|CEP granted\|11/01/2021; Monograph revision\|Accepted - CEP remains valid\|09/06/2020
1359	Pivmecillinam hydrochloride	FRESENIUS KABI IPSUM S.R.L. Cassina de' Pecchi IT	100015105;100057989	CEP 2004-262 - Rev 08	2026/02/10	Valid		Chemical	2026/02/10	Minor revision\|CEP granted\|10/02/2026; Notification\|Accepted - CEP remains valid\|22/05/2025; Minor revision\|CEP granted\|12/06/2024; Major revision\|CEP granted\|01/02/2023; Minor revision\|CEP granted\|17/01/2022; Notification\|CEP granted\|02/02/2021; Notification\|Accepted - CEP remains valid\|05/02/2020
2992	Lacosamide, Form-I	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2018-099 - Rev 04	2026/02/10	Valid		Chemical	2026/02/10	Minor revision\|CEP granted\|10/02/2026; Minor revision\|Accepted - CEP remains valid\|02/06/2025; Renewal\|CEP granted\|23/12/2024; Minor revision\|Accepted - CEP remains valid\|09/09/2022; Major revision\|CEP granted\|03/11/2021; Minor revision\|Rejected\|02/07/2021; Minor revision\|CEP granted\|31/08/2020
1491	Amlodipine besilate, ADP process	UNICHEM LABORATORIES LIMITED Mumbai IN	100005397;100093080	CEP 2024-371 - Rev 01	2026/02/10	Valid	28/05/2030	Chemical	2026/02/10	Monograph revision\|CEP granted\|10/02/2026; New application\|CEP granted\|28/05/2025
1681	Tramadol hydrochloride, Process-II	SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN	100008538;100018201	CEP 2020-141 - Rev 03	2026/02/10	Valid		Chemical	2026/02/10	Renewal\|CEP granted\|10/02/2026; Minor revision\|CEP granted\|14/06/2024; Minor revision\|CEP granted\|31/03/2021; New application\|CEP granted\|21/09/2020
758	Colchicine	INDIA GLYCOLS LIMITED Dehradun IN	100038944;100061244	CEP 2020-251 - Rev 01	2026/02/10	Valid	25/07/2027	Chemical	2026/02/10	Minor revision\|CEP granted\|10/02/2026; Monograph revision\|Accepted - CEP remains valid\|27/03/2025; New application\|CEP granted\|25/07/2022

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)	-