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
2736	Imatinib mesilate, β-Form	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2025-099 - Rev 00	2025/11/27	Valid	27/11/2030	Chemical	2025/11/27	New application\|CEP granted\|27/11/2025
388	Dexamethasone, Crystalline Form-A	XI’AN GUOKANG RUIJIN PHARMACEUTICAL CO., LTD. Xi’an City CN	100039231;100096104	CEP 2023-305 - Rev 00	2025/11/27	Valid	27/11/2030	Chemical	2025/11/27	New application\|CEP granted\|27/11/2025
711	Cyclophosphamide monohydrate	AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN	100045727;100075371	CEP 2025-325 - Rev 00	2025/11/27	Valid	27/11/2030	Chemical	2025/11/27	New application\|CEP granted\|27/11/2025
2016	Ondansetron hydrochloride dihydrate, Process-II	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2025-398 - Rev 00	2025/11/27	Valid	27/11/2030	Chemical	2025/11/27	New application\|CEP granted\|27/11/2025
168	Ampicillin trihydrate, Powder, Compacted	THE UNITED LABORATORIES (INNER MONGOLIA) CO., LTD. Bayannaoer CN	100025473;100034686	CEP 2025-304 - Rev 00	2025/11/27	Valid	27/11/2030	Chemical	2025/11/27	New application\|CEP granted\|27/11/2025
1681	Tramadol hydrochloride, Process II	SUPRIYA LIFESCIENCE LIMITED Mumbai IN	100015796;100024574	CEP 2025-354 - Rev 00	2025/11/27	Valid	27/11/2030	Chemical	2025/11/27	New application\|CEP granted\|27/11/2025
726	Levamisole Hydrochloride	JIANGSU TIANHE PHARMACEUTICAL CO., LTD. Yangzhou city CN	100041985;100069208	CEP 2022-498 - Rev 01	2025/11/26	Valid	26/03/2029	Chemical	2025/11/26	Minor revision\|CEP granted\|26/11/2025; New application\|CEP granted\|26/03/2024
1413	Dequalinium chloride	Laboratorios Espinos Y Bofill S.A. Cornella de Llobregat ES	100021595;100030302	CEP 2019-026 - Rev 03	2025/11/26	Valid		Chemical	2025/11/26	Renewal\|CEP granted\|26/11/2025; Monograph revision\|CEP granted\|17/02/2023; Administrative procedure\|CEP granted\|15/04/2021; Minor revision\|Accepted - CEP remains valid\|29/03/2021
561	Methylprednisolone, TY II	TIANJIN TIANYAO PHARMACEUTICALS CO., LTD. Tianjin CN	100011805;100018616	CEP 2012-307 - Rev 02	2025/11/26	Valid		Chemical	2025/11/26	Minor revision\|CEP granted\|26/11/2025; Notification\|CEP granted\|04/10/2022; Notification\|Rejected\|07/09/2022
353	Prednisolone, Form I, micronised	SHANDONG XINHUA PHARMACEUTICAL CO., LTD. Zibo CN	100011788;100019607	CEP 2023-412 - Rev 02	2025/11/26	Valid	17/06/2029	Chemical	2025/11/26	Minor revision\|CEP granted\|26/11/2025; Minor revision\|CEP granted\|02/12/2024; New application\|CEP granted\|17/06/2024
2932	Rivaroxaban	AMI LIFESCIENCES PRIVATE LIMITED Vadodara IN	100021822;100030527	CEP 2022-215 - Rev 02	2025/11/26	Valid	28/03/2029	Chemical	2025/11/26	Minor revision\|CEP granted\|26/11/2025; Minor revision\|CEP granted\|12/03/2025; New application\|CEP granted\|28/03/2024
2465	Irbesartan	MACLEODS PHARMACEUTICALS LIMITED Mumbai IN	100021441;100077265	CEP 2011-046 - Rev 07	2025/11/26	Valid		Chemical	2025/11/26	Major revision\|CEP granted\|26/11/2025; Notification\|CEP granted\|14/05/2025; Notification\|CEP granted\|07/11/2023; Major revision\|CEP granted\|11/05/2023; Notification\|Rejected\|08/03/2023; Minor revision\|Accepted - CEP remains valid\|30/06/2021; Minor revision\|CEP granted\|23/03/2021; Major revision\|CEP granted\|22/09/2020
871	Acebutolol hydrochloride	NURAY CHEMICALS PRIVATE LIMITED Thiruvallur IN	100048890;100081754	CEP 2024-109 - Rev 00	2025/11/26	Valid	26/11/2030	Chemical	2025/11/26	New application\|CEP granted\|26/11/2025
2888	Rupatadine fumarate	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2024-294 - Rev 01	2025/11/26	Valid	10/09/2030	Chemical	2025/11/26	Minor revision\|CEP granted\|26/11/2025; New application\|CEP granted\|10/09/2025
2992	Lacosamide	VASUDHA PHARMA CHEM LIMITED Hyderabad IN	100011811;100018603	CEP 2024-405 - Rev 00	2025/11/26	Valid	26/11/2030	Chemical	2025/11/26	New application\|CEP granted\|26/11/2025
2768	Fluticasone furoate, Micronised	VAMSI LABS LIMITED Solapur IN	100014747;100096958	CEP 2024-298 - Rev 00	2025/11/26	Valid	26/11/2030	Chemical	2025/11/26	New application\|CEP granted\|26/11/2025
2097	Mebeverine hydrochloride	VASUDHA PHARMA CHEM LIMITED Hyderabad IN	100011811;100018603	CEP 2024-278 - Rev 00	2025/11/26	Valid	26/11/2030	Chemical	2025/11/26	New application\|CEP granted\|26/11/2025
2790	Clopidogrel besilate	SYNTHIMED LABS PRIVATE LIMITED Derabassi IN	100052287;100092080	CEP 2024-347 - Rev 00	2025/11/26	Valid	26/11/2030	Chemical	2025/11/26	New application\|CEP granted\|26/11/2025
2306	Gemcitabine hydrochloride, Process-3	LAURUS LABS LIMITED Hyderabad IN	100011702;100032608	CEP 2025-445 - Rev 00	2025/11/26	Valid	26/11/2030	Chemical	2025/11/26	New application\|CEP granted\|26/11/2025
2765	Eplerenone, Form-L Site-II	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2025-487 - Rev 00	2025/11/26	Valid	26/11/2030	Chemical	2025/11/26	New application\|CEP granted\|26/11/2025

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)	-