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
1075	Budesonide	CORAL DRUGS PRIVATE LIMITED New Delhi IN	100019182;100042823	CEP 2016-020 - Rev 01	2026/01/06	Valid		Chemical	2026/01/06	Minor revision\|CEP granted\|06/01/2026; Renewal\|CEP granted\|15/11/2022
727	Lidocaine	APEX HEALTHCARE LIMITED Ankleshwar IN	100039365;100061975	CEP 2024-291 - Rev 00	2026/01/06	Valid	06/01/2031	Chemical	2026/01/06	New application\|CEP granted\|06/01/2026
760	Cytarabine	MAC CHEM PRODUCTS (INDIA) PRIVATE LIMITED Mumbai IN	100023737;100061579	CEP 2012-251 - Rev 03	2026/01/06	Valid		Chemical	2026/01/06	Notification\|CEP granted\|06/01/2026; Administrative procedure\|CEP granted\|30/04/2024; Minor revision\|CEP granted\|19/05/2022; Minor revision\|Accepted - CEP remains valid\|19/07/2021; Minor revision\|Rejected\|19/03/2021
2910	Trifluridine, Crystalline form	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2023-437 - Rev 00	2026/01/06	Valid	06/01/2031	Chemical	2026/01/06	New application\|CEP granted\|06/01/2026
97	Morphine hydrochloride trihydrate	S.A.L.A.R.S. S.p.A. Como IT	100017528;100026302	CEP 2009-339 - Rev 02	2026/01/06	Valid		Chemical	2026/01/06	Minor revision\|CEP granted\|06/01/2026; Monograph revision\|CEP granted\|20/06/2024
1362	Prilocaine	MOEHS IBERICA S.L. Rubi ES	100029092;100068825	CEP 2024-589 - Rev 00	2026/01/06	Valid	06/01/2031	Chemical	2026/01/06	New application\|CEP granted\|06/01/2026
1092	Cyclizine Hydrochloride	BAJAJ HEALTHCARE LIMITED Thane IN	100021782;100061986	CEP 2024-447 - Rev 00	2026/01/06	Valid	06/01/2031	Chemical	2026/01/06	New application\|CEP granted\|06/01/2026
1197	Dicycloverine Hydrochloride	AMI LIFESCIENCES PRIVATE LIMITED Vadodara IN	100021822;100030527	CEP 2024-517 - Rev 00	2026/01/06	Valid	06/01/2031	Chemical	2026/01/06	New application\|CEP granted\|06/01/2026
1276	Vindesine sulfate	MINAKEM Dunkerque FR	100032366;100056463	CEP 2025-393 - Rev 01	2026/01/06	Valid	22/09/2030	Chemical	2026/01/06	Minor revision\|CEP granted\|06/01/2026; New application\|CEP granted\|22/09/2025
1611	Diosmin, Process II, Micronised, non-micronised	SICHUAN XIELI PHARMACEUTICAL CO., LTD. Pengzhou CN	100017947;100052361	CEP 2025-416 - Rev 00	2026/01/06	Valid	06/01/2031	Chemical	2026/01/06	New application\|CEP granted\|06/01/2026
2856	Pirfenidone, Process II	HONOUR LAB LIMITED Hyderabad IN	100011891;100097835	CEP 2025-392 - Rev 00	2025/12/22	Valid	22/12/2030	Chemical	2025/12/22	New application\|CEP granted\|22/12/2025
1075	Budesonide, Micronised, non-micronised	MINAKEM Dunkerque FR	100032366;100056463	CEP 2010-190 - Rev 04	2025/12/22	Valid		Chemical	2025/12/22	Minor revision\|CEP granted\|22/12/2025; Minor revision\|Accepted - CEP remains valid\|29/08/2024; Minor revision\|Accepted - CEP remains valid\|17/02/2023; Notification\|Accepted - CEP remains valid\|03/06/2021; Minor revision\|CEP granted\|09/06/2020
2606	Tadalafil, Form-I, Micronised, Non-micronised, Milled and Non-milled	MSN ORGANICS PRIVATE LIMITED Bibinagar Village IN	100012074;100018617	CEP 2011-366 - Rev 01	2025/12/22	Valid		Chemical	2025/12/22	Minor revision\|CEP granted\|22/12/2025; Minor revision\|Accepted - CEP remains valid\|01/03/2022
194	Sodium dihydrogen phosphate dihydrate	DR. PAUL LOHMANN GMBH & CO. KGAA Emmerthal DE	100022728;100031429	CEP 2019-228 - Rev 02	2025/12/22	Valid		Chemical	2025/12/22	Renewal\|CEP granted\|22/12/2025; Minor revision\|CEP granted\|04/10/2023
2131	Tamsulosin hydrochloride	SHANGHAI PHARMA GROUP CHANGZHOU KONY PHARMACEUTICAL CO., LTD. Luoyang Town CN	100020594;100034407	CEP 2024-421 - Rev 00	2025/12/22	Valid	22/12/2030	Chemical	2025/12/22	New application\|CEP granted\|22/12/2025
1970	Atracurium besilate, Manufacturing code: 55	CF PHARMA LTD. Budapest HU	100022980;100031712	CEP 2020-436 - Rev 03	2025/12/22	Valid		Chemical	2025/12/22	Renewal\|CEP granted\|22/12/2025; Minor revision\|CEP granted\|25/01/2024; Minor revision\|Accepted - CEP remains valid\|01/02/2022; Minor revision\|Accepted - CEP remains valid\|18/11/2021; Administrative procedure\|CEP granted\|11/02/2021; New application\|CEP granted\|08/01/2021
1346	Metamizole sodium monohydrate	EUROAPI GERMANY GmbH Frankfurt am Main DE	100039255;100061797	CEP 2000-277 - Rev 07	2025/12/22	Valid		Chemical	2025/12/22	Minor revision\|CEP granted\|22/12/2025; Minor revision\|Accepted - CEP remains valid\|27/03/2023; Transfer of holdership\|CEP granted\|10/12/2021
565	Sodium nitroprusside	HAINAN POLY PHARMACEUTICAL COMPANY LIMITED Haikou CN	100024397;100033569	CEP 2020-114 - Rev 02	2025/12/22	Valid		Chemical	2025/12/22	Renewal\|CEP granted\|22/12/2025; Minor revision\|CEP granted\|14/03/2022; New application\|CEP granted\|12/04/2021
890	Clonazepam, Non-micronised, micronised	F.I.S. - FABBRICA ITALIANA SINTETICI S.P.A. Montecchio Maggiore IT	100011866;100022277	CEP 2013-037 - Rev 02	2025/12/22	Valid		Chemical	2025/12/22	Minor revision\|CEP granted\|22/12/2025; Minor revision\|Accepted - CEP remains valid\|04/02/2025; Minor revision\|Accepted - CEP remains valid\|05/09/2024; Minor revision\|CEP granted\|23/11/2022; Renewal\|CEP granted\|07/08/2020
2574	Entacapone	COHANCE LIFESCIENCES LIMITED Mumbai IN	100011755;100090273	CEP 2010-337 - Rev 04	2025/12/22	Valid		Chemical	2025/12/22	Major revision\|CEP granted\|22/12/2025; Notification\|CEP granted\|15/12/2022; Notification\|CEP granted\|23/11/2022; Minor revision\|CEP granted\|20/06/2022

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)	-