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	PHARMATEC Q LIMITED Swords IE	100036336;100095600	CEP 2018-286 - Rev 02	2025/06/30	Valid		Chemical	2025/06/30	Renewal\|CEP granted\|30/06/2025; Minor revision\|CEP granted\|17/01/2023
330	Gelatin, Limed bone gelatin	Jilin Tianzheng Biotechnology Co. Ltd. Jiaohe City CN	100052420;100092302	CEP 2024-416 - Rev 00	2025/06/30	Valid	30/06/2030	TSE	2025/06/30	New application\|CEP granted\|30/06/2025
330	Gelatin, Enzymatic Hide Gelatin Hydrolysate, acid process	GELITA AG Eberbach DE	100012955;100080863	CEP 2023-428 - Rev 00	2025/06/30	Valid	30/06/2030	TSE	2025/06/30	New application\|CEP granted\|30/06/2025
3087	Ticagrelor	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2021-225 - Rev 01	2025/06/27	Valid	23/11/2028	Chemical	2025/06/27	Minor revision\|CEP granted\|27/06/2025; New application\|CEP granted\|23/11/2023
2675	Irinotecan hydrochloride trihydrate, Form-B	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2019-021 - Rev 03	2025/06/27	Valid	06/10/2026	Chemical	2025/06/27	Major revision\|CEP granted\|27/06/2025; Minor revision\|CEP granted\|16/05/2023; Major revision\|CEP granted\|14/06/2022
1970	Atracurium besilate	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2006-044 - Rev 07	2025/06/27	Valid		Chemical	2025/06/27	Notification\|CEP granted\|27/06/2025; Minor revision\|Accepted - CEP remains valid\|25/09/2024; Minor revision\|Accepted - CEP remains valid\|25/01/2023; Notification\|CEP granted\|22/11/2021; Notification\|CEP granted\|11/09/2020; Minor revision\|CEP granted\|08/06/2020
2372	Esomeprazole magnesium trihydrate	NIFTY LABS PRIVATE LIMITED Hyderabad IN	100014767;100042749	CEP 2018-245 - Rev 05	2025/06/27	Valid		Chemical	2025/06/27	Administrative procedure\|CEP granted\|27/06/2025; Administrative procedure\|CEP granted\|05/06/2025; Renewal\|CEP granted\|23/05/2025; Minor revision\|CEP granted\|12/12/2023; Notification\|CEP granted\|16/08/2022
1490	Amisulpride	SANOFI WINTHROP INDUSTRIE Gentilly FR	100011564;100021551	CEP 2002-208 - Rev 11	2025/06/27	Valid		Chemical	2025/06/27	Minor revision\|CEP granted\|27/06/2025; Notification\|Accepted - CEP remains valid\|05/05/2025; Minor revision\|CEP granted\|27/05/2024; Notification\|CEP granted\|28/03/2024; Notification\|CEP granted\|05/01/2022
810	Betamethasone sodium phosphate, Process III	CURIA SPAIN S.A.U. Boecillo ES	100011649;100019586	CEP 2025-201 - Rev 00	2025/06/27	Valid	27/06/2030	Chemical	2025/06/27	New application\|CEP granted\|27/06/2025
1721	Flubendazole	ALIVIRA ANIMAL HEALTH LIMITED Visakhapatnam IN	100033528;100052489	CEP 2022-381 - Rev 00	2025/06/27	Valid	27/06/2030	Chemical	2025/06/27	New application\|CEP granted\|27/06/2025
3132	Mirabegron, alpha form	AMOLI ORGANICS PRIVATE LIMITED Mumbai IN	100016500;100025303	CEP 2024-208 - Rev 00	2025/06/27	Valid	27/06/2030	Chemical	2025/09/10	Major revision\|Accepted - CEP remains valid\|10/09/2025; New application\|CEP granted\|27/06/2025
3132	Mirabegron, Form-α	DR. REDDY'S LABORATORIES LIMITED Hyderabad IN	100003991;100000217	CEP 2024-033 - Rev 00	2025/06/27	Valid	27/06/2030	Chemical	2025/06/27	New application\|CEP granted\|27/06/2025
1449	Mometasone furoate	SHANDONG SIRUI PHARMACEUTICAL CO., LTD. Heze CN	100049295;100083729	CEP 2024-044 - Rev 00	2025/06/27	Valid	27/06/2030	Chemical	2025/06/27	New application\|CEP granted\|27/06/2025
471	Calcitonin (salmon), Synthetic	PIRAMAL PHARMA LIMITED Navi Mumbai IN	100036948;100075608	CEP 2012-236 - Rev 02	2025/06/25	Valid		Chemical	2025/06/25	Minor revision\|CEP granted\|25/06/2025; Notification\|CEP granted\|04/10/2022
2573	Candesartan cilexetil	JIANGXI SYNERGY PHARMACEUTICAL CO., LTD. Yichun CN	100020812;100080065	CEP 2013-007 - Rev 05	2025/06/25	Valid		Chemical	2025/06/25	Minor revision\|CEP granted\|25/06/2025; Minor revision\|CEP granted\|28/08/2024; Notification\|CEP granted\|20/09/2023; Notification\|CEP granted\|21/03/2023; Minor revision\|Accepted - CEP remains valid\|01/09/2021; Minor revision\|CEP granted\|24/11/2020; Notification\|Abandoned\|09/10/2020
2420	Tiotropium bromide monohydrate, Micronised, non-micronised	VAMSI LABS LIMITED Solapur IN	100014747;100096958	CEP 2012-285 - Rev 03	2025/06/25	Valid		Chemical	2025/06/25	Notification\|CEP granted\|25/06/2025; Minor revision\|CEP granted\|16/01/2024; Notification\|Rejected\|14/09/2023; Notification\|CEP granted\|28/07/2022
946	Ranitidine hydrochloride, Crystalline powder grade and D.C. grade	ORCHEV PHARMA PRIVATE LIMITED Rajkot IN	100020650;100029403	CEP 2007-320 - Rev 04	2025/06/25	Valid		Chemical	2025/06/25	Administrative procedure\|CEP granted\|25/06/2025
1280	Zolpidem tartrate	CENTAUR PHARMACEUTICALS PRIVATE LIMITED Mumbai IN	100018245;100028824	CEP 2002-171 - Rev 07	2025/06/25	Valid		Chemical	2025/06/25	Minor revision\|CEP granted\|25/06/2025; Notification\|CEP granted\|20/10/2023
1058	Vancomycin hydrochloride	XELLIA PHARMACEUTICALS LTD. Budapest X HU	100012234;100020635	CEP 1999-110 - Rev 11	2025/06/25	Valid		Chemical	2025/06/25	Minor revision\|CEP granted\|25/06/2025; Minor revision\|CEP granted\|21/02/2023; Notification\|Accepted - CEP remains valid\|11/01/2021
2582	Donepezil hydrochloride, Monohydrate	NEULAND LABORATORIES LIMITED Hyderabad IN	100011545;100062134	CEP 2019-311 - Rev 02	2025/06/25	Valid	19/10/2026	Chemical	2025/12/02	Minor revision\|Accepted - CEP remains valid\|02/12/2025; Minor revision\|CEP granted\|25/06/2025; Minor revision\|Accepted - CEP remains valid\|12/12/2024; Monograph revision\|Accepted - CEP remains valid\|13/12/2023; Major revision\|CEP granted\|31/01/2024

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)	-