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
2777	Pregabalin, Process II	ZHEJIANG BAMBOO PHARMACEUTICALS CO.,LTD. Shaoxing CN	100047946;100079294	CEP 2025-610 - Rev 00	2026/04/23	Valid	23/04/2031	Chemical	2026/04/23	New application\|CEP granted\|23/04/2026
1009	Domperidone	HALEOS LABS LIMITED Hyderabad IN	100039495;100077080	CEP 2024-104 - Rev 00	2026/04/23	Valid	23/04/2031	Chemical	2026/04/23	New application\|CEP granted\|23/04/2026
3135	Rosuvastatin zinc tetrahydrate, Process 1, form I, milled	EGIS PHARMACEUTICALS PLC. Budapest X HU	100001091;100001662	CEP 2025-502 - Rev 00	2026/04/23	Valid	23/04/2031	Chemical	2026/04/23	New application\|CEP granted\|23/04/2026
1654	Lymecycline	CIPAN - COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS, S.A. Castanheira do Ribatejo PT	100021412;100078598	CEP 2010-239 - Rev 03	2026/04/23	Valid		Chemical	2026/04/23	Minor revision\|CEP granted\|23/04/2026; Minor revision\|CEP granted\|09/02/2023; Minor revision\|Accepted - CEP remains valid\|30/04/2020
663	Dicloxacillin sodium monohydrate, Powder and compacted	FRESENIUS KABI IPSUM S.R.L. Cassina de' Pecchi IT	100015105;100057989	CEP 2002-036 - Rev 10	2026/04/23	Valid		Chemical	2026/04/23	Monograph revision\|CEP granted\|23/04/2026; Administrative procedure\|CEP granted\|21/03/2025; Notification\|CEP granted\|14/03/2025; Minor revision\|CEP granted\|16/08/2021; Notification\|CEP granted\|02/02/2021
2192	Atovaquone, Form A, Process-II	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2025-001 - Rev 01	2026/04/23	Valid	25/06/2030	Chemical	2026/04/23	Minor revision\|CEP granted\|23/04/2026; New application\|CEP granted\|25/06/2025
668	Flucloxacillin sodium monohydrate, Powder and compacted	FRESENIUS KABI IPSUM S.R.L. Cassina de' Pecchi IT	100015105;100057989	CEP 1996-054 - Rev 12	2026/04/22	Valid		Chemical	2026/04/22	Minor revision\|CEP granted\|22/04/2026; Minor revision\|CEP granted\|24/01/2025; Monograph revision\|CEP granted\|18/05/2022; Notification\|CEP granted\|11/02/2021
2004	Sotalol hydrochloride	NEULAND LABORATORIES LIMITED Hyderabad IN	100011545;100062134	CEP 2001-269 - Rev 11	2026/04/22	Valid		Chemical	2026/04/22	Minor revision\|CEP granted\|22/04/2026; Minor revision\|CEP granted\|10/04/2025; Monograph revision\|CEP granted\|06/03/2024; Minor revision\|Accepted - CEP remains valid\|04/07/2023; Notification\|CEP granted\|29/03/2023; Notification\|CEP granted\|06/12/2021; Minor revision\|Accepted - CEP remains valid\|09/09/2021
1004	Diltiazem hydrochloride	PIRAMAL PHARMA LIMITED Digwal Village IN	100036948;100058375	CEP 1997-121 - Rev 15	2026/04/22	Valid		Chemical	2026/04/22	Minor revision\|CEP granted\|22/04/2026; Notification\|CEP granted\|07/01/2022; Minor revision\|CEP granted\|18/03/2021
1695	Granisetron hydrochloride	CIPLA LIMITED Mumbai IN	100006004;100018147	CEP 2007-051 - Rev 03	2026/04/22	Valid		Chemical	2026/04/22	Minor revision\|CEP granted\|22/04/2026
1208	Fenbendazole for veterinary use	ALIVIRA ANIMAL HEALTH LIMITED Visakhapatnam IN	100033528;100052489	CEP 2004-212 - Rev 06	2026/04/22	Valid		Chemical	2026/04/22	Minor revision\|CEP granted\|22/04/2026; Minor revision\|Accepted - CEP remains valid\|19/06/2025; Minor revision\|CEP granted\|21/03/2025; Minor revision\|Accepted - CEP remains valid\|22/08/2024; Monograph revision\|Accepted - CEP remains valid\|13/06/2024; Notification\|CEP granted\|30/03/2023; Minor revision\|Rejected\|30/07/2021
147	Naphazoline nitrate	C-SQUARED PHARMA LIMITED Cork IE	100045238;100077698	CEP 2025-360 - Rev 00	2026/04/22	Valid	22/04/2031	Chemical	2026/04/22	New application\|CEP granted\|22/04/2026
2778	Sitagliptin phosphate monohydrate, 1567	MACLEODS PHARMACEUTICALS LIMITED Mumbai IN	100021441;100077265	CEP 2024-229 - Rev 02	2026/04/22	Valid	10/04/2030	Chemical	2026/04/22	Notification\|CEP granted\|22/04/2026; Minor revision\|CEP granted\|17/06/2025; New application\|CEP granted\|10/04/2025
2127	Clobetasol propionate	HENAN LIHUA PHARMACEUTICAL CO., LTD. Anyang CN	100016183;100024971	CEP 2020-395 - Rev 01	2026/04/22	Valid		Chemical	2026/04/22	Renewal\|CEP granted\|22/04/2026; New application\|CEP granted\|01/06/2021
2778	Sitagliptin phosphate monohydrate	LEE PHARMA LIMITED Hyderabad IN	100014849;100042625	CEP 2022-042 - Rev 01	2026/04/22	Valid	06/03/2029	Chemical	2026/04/22	Minor revision\|CEP granted\|22/04/2026; New application\|CEP granted\|06/03/2024
573	Verapamil hydrochloride	MATRIX PHARMACORP PRIVATE LIMITED Sangareddy IN	100051463;100098142	CEP 2018-204 - Rev 03	2026/04/22	Valid		Chemical	2026/04/22	Renewal\|CEP granted\|22/04/2026; Administrative procedure\|CEP granted\|27/09/2024; Notification\|CEP granted\|07/08/2024
2077	Metacresol	MEDILUX LABORATORIES PRIVATE LIMITED Pithampur IN	100023732;100032901	CEP 2023-353 - Rev 02	2026/04/21	Valid	05/03/2030	Chemical	2026/04/21	Minor revision\|CEP granted\|21/04/2026; Minor revision\|CEP granted\|08/08/2025; Notification\|Rejected\|20/06/2025; New application\|CEP granted\|05/03/2025
2375	Raloxifene hydrochloride	AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN	100046306;100076393	CEP 2022-165 - Rev 01	2026/04/21	Valid	22/04/2029	Chemical	2026/04/21	Minor revision\|CEP granted\|21/04/2026; New application\|CEP granted\|22/04/2024
2244	Tacrolimus monohydrate	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2018-233 - Rev 07	2026/04/21	Valid		Chemical	2026/04/21	Minor revision\|CEP granted\|21/04/2026; Administrative procedure\|CEP granted\|11/03/2025; Notification\|CEP granted\|04/03/2025; Renewal\|CEP granted\|05/08/2024; Minor revision\|Accepted - CEP remains valid\|17/11/2023; Minor revision\|CEP granted\|25/11/2022; Major revision\|CEP granted\|06/04/2022; Minor revision\|Rejected\|04/11/2021; Minor revision\|CEP granted\|01/09/2020
1708	Azaperone for veterinary use	MINAKEM Dunkerque FR	100032366;100056463	CEP 2013-013 - Rev 01	2026/04/21	Valid		Chemical	2026/04/21	Major revision\|CEP granted\|21/04/2026

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)	-