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
2097	Mebeverine hydrochloride	PIRAMAL PHARMA LIMITED Digwal Village IN	100036948;100058375	CEP 2019-271 - Rev 04	2026/04/16	Valid		Chemical	2026/04/16	Renewal\|CEP granted\|16/04/2026; Monograph revision\|Accepted - CEP remains valid\|12/08/2022; Notification\|CEP granted\|07/01/2022; Administrative procedure\|CEP granted\|12/07/2021; Minor revision\|CEP granted\|29/06/2021
1074	Biperiden hydrochloride, Bipe HCl 38	CF PHARMA KFT. Budapest IX HU	100022980;100031712	CEP 2020-317 - Rev 02	2026/04/16	Valid		Chemical	2026/04/16	Renewal\|CEP granted\|16/04/2026; Minor revision\|CEP granted\|18/12/2025; Minor revision\|Accepted - CEP remains valid\|02/01/2024; New application\|CEP granted\|17/03/2021
412	Sodium citrate dihydrate	MACCO ORGANIQUES, S.R.O. Bruntal CZ	100017613;100026377	CEP 2025-359 - Rev 00	2026/04/16	Valid	16/04/2031	Chemical	2026/04/16	New application\|CEP granted\|16/04/2026
687	Salbutamol sulfate, Process III, Non-micronised and Micronised	CIPLA LIMITED Mumbai IN	100006004;100018147	CEP 2025-002 - Rev 01	2026/04/16	Valid	20/06/2030	Chemical	2026/04/16	Minor revision\|CEP granted\|16/04/2026; New application\|CEP granted\|20/06/2025
1115	Iopamidol	DONGKOOK LIFE SCIENCE CO. LTD. Gyeonggi-do KR	100049186;100083264	CEP 2023-300 - Rev 00	2026/04/16	Valid	16/04/2031	Chemical	2026/04/16	New application\|CEP granted\|16/04/2026
627	Nifedipine	SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN	100044578;100073706	CEP 2022-475 - Rev 01	2026/04/16	Valid	18/11/2029	Chemical	2026/04/16	Monograph revision\|CEP granted\|16/04/2026; New application\|CEP granted\|18/11/2024
848	Sodium fusidate, Micronised, Process II	LEO PHARMA A/S Ballerup DK	100001545;100005213	CEP 2021-041 - Rev 02	2026/04/16	Valid		Chemical	2026/04/16	Renewal\|CEP granted\|16/04/2026; Notification\|CEP granted\|19/01/2022; New application\|CEP granted\|04/06/2021
848	Sodium fusidate, Process II	LEO PHARMA A/S Ballerup DK	100001545;100005213	CEP 2021-042 - Rev 01	2026/04/15	Valid		Chemical	2026/04/15	Renewal\|CEP granted\|15/04/2026; New application\|CEP granted\|04/06/2021
2781	Tolterodine tartrate	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2020-032 - Rev 02	2026/04/15	Valid		Chemical	2026/04/15	Renewal\|CEP granted\|15/04/2026; Minor revision\|CEP granted\|25/04/2025; Minor revision\|Accepted - CEP remains valid\|24/08/2023; New application\|CEP granted\|17/03/2021
3014	Rotigotine	INTERQUIM S.A. Sant Cugat Del Valles ES	100011698;100021071	CEP 2019-302 - Rev 03	2026/04/13	Valid		Chemical	2026/04/13	Renewal\|CEP granted\|13/04/2026; Minor revision\|CEP granted\|07/07/2025; Minor revision\|CEP granted\|03/05/2024; Minor revision\|Accepted - CEP remains valid\|18/02/2022; Notification\|Rejected\|08/12/2021
2074	Tioconazole	OPTIMUS DRUGS PRIVATE LIMITED Hyderabad IN	100020646;100092226	CEP 2020-068 - Rev 03	2026/04/13	Valid		Chemical	2026/04/13	Renewal\|CEP granted\|13/04/2026; Major revision\|CEP granted\|23/02/2024; Minor revision\|CEP granted\|04/07/2022; New application\|CEP granted\|20/05/2021
758	Colchicine	INDIA GLYCOLS LIMITED Dehradun IN	100038944;100061244	CEP 2020-251 - Rev 02	2026/04/13	Valid	25/07/2027	Chemical	2026/04/13	Minor revision\|CEP granted\|13/04/2026; Minor revision\|CEP granted\|10/02/2026; Monograph revision\|Accepted - CEP remains valid\|27/03/2025; New application\|CEP granted\|25/07/2022
916	Hydroxyzine hydrochloride	IPCA LABORATORIES LIMITED Mumbai IN	100011685;100018680	CEP 2010-076 - Rev 05	2026/04/13	Valid		Chemical	2026/04/13	Monograph revision\|CEP granted\|13/04/2026; Minor revision\|CEP granted\|25/04/2025; Minor revision\|CEP granted\|11/09/2024; Notification\|Accepted - CEP remains valid\|23/06/2023; Minor revision\|CEP granted\|03/08/2021
750	Glutamic Acid	AMINO GMBH Frellstedt DE	100011599;100021107	CEP 2019-279 - Rev 01	2026/04/13	Valid		Chemical	2026/04/13	Renewal\|CEP granted\|13/04/2026
1002	Diclofenac sodium	AARTI DRUGS LIMITED Mumbai IN	100014953;100023652	CEP 2021-246 - Rev 01	2026/04/13	Valid	26/01/2029	Chemical	2026/04/13	Minor revision\|CEP granted\|13/04/2026; New application\|CEP granted\|26/01/2024
576	Allopurinol	ASSURGEN PHARMA PRIVATE LIMITED Visakhapatnam IN	100048048;100101722	CEP 2022-390 - Rev 01	2026/04/10	Valid	28/03/2030	Chemical	2026/04/10	Notification\|CEP granted\|10/04/2026; New application\|CEP granted\|28/03/2025
542	Busulfan	EMCURE PHARMACEUTICALS LIMITED Pune IN	100011677;100099996	CEP 2013-341 - Rev 02	2026/04/10	Valid		Chemical	2026/04/10	Notification\|CEP granted\|10/04/2026; Notification\|CEP granted\|31/08/2023; Renewal\|CEP granted\|23/02/2021
573	Verapamil hydrochloride	ASSURGEN PHARMA PRIVATE LIMITED Visakhapatnam IN	100048048;100101722	CEP 2019-014 - Rev 03	2026/04/10	Valid		Chemical	2026/04/10	Notification\|CEP granted\|10/04/2026; Renewal\|CEP granted\|13/01/2026; Minor revision\|CEP granted\|20/02/2023
2296	Pantoprazole sodium sesquihydrate	ASSURGEN PHARMA PRIVATE LIMITED Visakhapatnam IN	100048048;100101722	CEP 2018-199 - Rev 02	2026/04/10	Valid		Chemical	2026/04/10	Notification\|CEP granted\|10/04/2026; Renewal\|CEP granted\|04/03/2025
2576	Voriconazole, Form-I	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2018-184 - Rev 03	2026/04/10	Valid		Chemical	2026/04/10	Major revision\|CEP granted\|10/04/2026; Renewal\|Accepted - CEP remains valid\|24/11/2025; Minor revision\|CEP granted\|16/09/2024; Major revision\|CEP granted\|01/12/2022; Minor revision\|Rejected\|02/03/2022

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)	-