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
2583	Montelukast sodium	SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN	100044578;100073706	CEP 2024-125 - Rev 00	2025/12/03	Valid	03/12/2030	Chemical	2025/12/03	New application\|CEP granted\|03/12/2025
391	Furosemide, Alternative process	SRI KRISHNA PHARMACEUTICALS LIMITED Hyderabad IN	100015104;100023787	CEP 2013-273 - Rev 01	2025/12/03	Valid		Chemical	2025/12/03	Minor revision\|CEP granted\|03/12/2025; Minor revision\|Accepted - CEP remains valid\|20/09/2022; Minor revision\|Accepted - CEP remains valid\|21/03/2022
3095	Dabigatran etexilate mesilate	HIKAL LIMITED Bangalore IN	100014769;100023445	CEP 2024-363 - Rev 00	2025/12/03	Valid	03/12/2030	Chemical	2025/12/03	New application\|CEP granted\|03/12/2025
930	Lysine Hydrochloride	EVONIK REXIM S.A.S. Ham FR	100012329;100020964	CEP 2003-057 - Rev 06	2025/12/03	Valid		Chemical	2025/12/03	Minor revision\|CEP granted\|03/12/2025; Notification\|CEP granted\|04/04/2022
2617	Aripiprazole	OLON S.P.A. Rodano IT	100012085;100019537	CEP 2014-188 - Rev 02	2025/12/03	Valid		Chemical	2025/12/03	Administrative procedure\|CEP granted\|03/12/2025; Minor revision\|CEP granted\|07/11/2025; Renewal\|CEP granted\|02/06/2021; Minor revision\|Accepted - CEP remains valid\|12/10/2020
3087	Ticagrelor	Changzhou Pharmaceutical Factory Changzhou CN	100012704;100018611	CEP 2021-333 - Rev 02	2025/12/03	Valid	26/05/2028	Chemical	2025/12/03	Minor revision\|CEP granted\|03/12/2025; Minor revision\|CEP granted\|26/08/2024; New application\|CEP granted\|30/05/2023
1732	Norgestimate, Optimized process	STERLING S.p.A. Solomeo Di Corciano IT	100024377;100033551	CEP 2021-049 - Rev 03	2025/12/03	Valid	03/01/2027	Chemical	2025/12/03	Minor revision\|CEP granted\|03/12/2025; Notification\|CEP granted\|12/10/2022; Minor revision\|Rejected\|03/02/2023; Minor revision\|CEP granted\|13/04/2022; New application\|CEP granted\|03/01/2022
665	Econazole nitrate, Powder, micronised	PMC ISOCHEM Vert Le Petit FR	100011861;100020972	CEP 2019-074 - Rev 02	2025/12/03	Valid		Chemical	2025/12/03	Renewal\|CEP granted\|03/12/2025; Minor revision\|CEP granted\|08/04/2025
1655	Mitomycin	CONCORD BIOTECH LIMITED Ahmedabad IN	100005519;100000897	CEP 2019-308 - Rev 01	2025/12/02	Valid		Chemical	2025/12/02	Renewal\|CEP granted\|02/12/2025
2330	Leflunomide	MAPRIMED S.A. Buenos Aires AR	100012039;100018552	CEP 2018-252 - Rev 03	2025/12/02	Valid		Chemical	2025/12/02	Renewal\|CEP granted\|02/12/2025; Minor revision\|CEP granted\|03/06/2025; Notification\|Accepted - CEP remains valid\|04/12/2023; Minor revision\|CEP granted\|27/10/2022; Minor revision\|Rejected\|24/05/2022
2119	Venlafaxine hydrochloride, Standard and milled, form II	MOEHS IBERICA S.L. Rubi ES	100029092;100068825	CEP 2006-182 - Rev 05	2025/12/02	Valid		Chemical	2025/12/02	Minor revision\|CEP granted\|02/12/2025; Notification\|Accepted - CEP remains valid\|21/02/2023; Minor revision\|Accepted - CEP remains valid\|28/07/2022; Minor revision\|Accepted - CEP remains valid\|28/03/2022; Minor revision\|Accepted - CEP remains valid\|24/01/2022; Minor revision\|Accepted - CEP remains valid\|19/03/2021
748	Vinblastine Sulfate, Process 2	MINAKEM HIGH POTENT Mont-Saint-Guibert BE	100011725;100022401	CEP 2020-065 - Rev 02	2025/12/02	Valid		Chemical	2025/12/02	Renewal\|CEP granted\|02/12/2025; Notification\|Accepted - CEP remains valid\|02/04/2024; Minor revision\|CEP granted\|17/07/2023; New application\|CEP granted\|09/09/2020
1449	Mometasone furoate, Micronised	STERLING S.p.A. Solomeo Di Corciano IT	100024377;100033551	CEP 2025-335 - Rev 01	2025/12/02	Valid	17/11/2030	Chemical	2025/12/02	Minor revision\|CEP granted\|02/12/2025; New application\|CEP granted\|17/11/2025
388	Dexamethasone, Process II	TIANJIN TIANYAO PHARMACEUTICALS CO., LTD. Tianjin CN	100011805;100018616	CEP 2020-270 - Rev 01	2025/12/02	Valid	31/03/2027	Chemical and TSE	2025/12/02	Minor revision\|CEP granted\|02/12/2025; New application\|CEP granted\|31/03/2022
1750	Fluticasone propionate, Micronised	HOVIONE FARMACIENCIA S.A. Loures PT	100001467;100000315	CEP 2005-160 - Rev 03	2025/12/02	Valid		Chemical	2025/12/02	Minor revision\|CEP granted\|02/12/2025; Monograph revision\|Accepted - CEP remains valid\|15/04/2021; Minor revision\|Accepted - CEP remains valid\|13/10/2020; Notification\|Rejected\|06/07/2020
2751	Valaciclovir hydrochloride hydrate	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2018-102 - Rev 04	2025/12/01	Valid		Chemical	2025/12/01	Notification\|CEP granted\|01/12/2025; Renewal\|CEP granted\|25/04/2025; Minor revision\|Accepted - CEP remains valid\|20/08/2024; Minor revision\|CEP granted\|20/02/2024; Minor revision\|Accepted - CEP remains valid\|27/01/2021; Minor revision\|CEP granted\|07/08/2020
1511	Enoxolone	ALCHEM INTERNATIONAL PRIVATE LIMITED Faridabad IN	100011947;100018683	CEP 2018-263 - Rev 02	2025/12/01	Valid		Chemical	2025/12/01	Renewal\|CEP granted\|01/12/2025; Monograph revision\|CEP granted\|22/06/2023; Minor revision\|Accepted - CEP remains valid\|03/08/2022
2896	Thiocolchicoside crystallised from ethanol	ALCHEM INTERNATIONAL PRIVATE LIMITED Faridabad IN	100011947;100018683	CEP 2018-128 - Rev 01	2025/12/01	Valid		Chemical	2025/12/01	Renewal\|CEP granted\|01/12/2025
626	Neostigmine metilsulfate	MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN	100011732;100018657	CEP 2016-044 - Rev 01	2025/12/01	Valid		Chemical	2025/12/01	Minor revision\|CEP granted\|01/12/2025; Renewal\|CEP granted\|09/09/2022; Minor revision\|CEP granted\|16/12/2020
561	Methylprednisolone, Micronised	SYMBIOTEC PHARMALAB PRIVATE LIMITED Indore IN	100018972;100095999	CEP 2014-015 - Rev 02	2025/12/01	Valid		Chemical	2025/12/01	Minor revision\|CEP granted\|01/12/2025; Minor revision\|CEP granted\|03/05/2022

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)	-