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
2372	Esomeprazole magnesium trihydrate	METROCHEM API PRIVATE LIMITED Hyderabad IN	100045158;100074519	CEP 2020-386 - Rev 03	2026/01/26	Valid	24/05/2027	Chemical	2026/01/26	Minor revision\|CEP granted\|26/01/2026; Minor revision\|CEP granted\|26/08/2024; Notification\|CEP granted\|14/06/2024; New application\|CEP granted\|24/05/2022
2993	Nilotinib hydrochloride monohydrate	RAVI BIOLIFE PRIVATE LIMITED Mumbai IN	100048404;100086771	CEP 2022-425 - Rev 01	2026/01/26	Valid	19/04/2029	Chemical	2026/01/26	Minor revision\|CEP granted\|26/01/2026; New application\|CEP granted\|19/04/2024
1275	Ursodeoxycholic acid	SUZHOU TIANLU BIO-PHARMACEUTICAL CO. LTD. Suzhou CN	100018634;100027427	CEP 2023-317 - Rev 02	2026/01/26	Valid	07/02/2030	Chemical	2026/01/26	Monograph revision\|CEP granted\|26/01/2026; Administrative procedure\|CEP granted\|03/03/2025; New application\|CEP granted\|07/02/2025
2888	Rupatadine fumarate	MOREPEN LABORATORIES LIMITED Baddi IN	100017843;100026642	CEP 2025-532 - Rev 00	2026/01/26	Valid	26/01/2031	Chemical	2026/01/26	New application\|CEP granted\|26/01/2026
2541	Quetiapine Fumarate	ALKEM LABORATORIES LIMITED Mumbai IN	100005554;100010367	CEP 2025-036 - Rev 00	2026/01/23	Valid	23/01/2031	Chemical	2026/01/23	New application\|CEP granted\|23/01/2026
3137	Dapagliflozin propylene glycol monohydrate, SC-3 crystalline form, Micronised and Non-Micronised	MSN LABORATORIES PRIVATE LIMITED Sangareddy IN	100011732;100018657	CEP 2025-239 - Rev 00	2026/01/23	Valid	23/01/2031	Chemical	2026/01/23	New application\|CEP granted\|23/01/2026
2600	Olmesartan medoxomil, Process-II, Micronised, non-micronised	CPL PHARMACEUTICALS PRIVATE LIMITED Ahmedabad IN	100048075;100079517	CEP 2025-511 - Rev 00	2026/01/23	Valid	23/01/2031	Chemical	2026/01/23	New application\|CEP granted\|23/01/2026
1442	Leuprorelin, Process F	POLYPEPTIDE LABORATORIES (SWEDEN) AB Limhamn SE	100011740;100020303	CEP 2011-321 - Rev 03	2026/01/23	Valid		Chemical	2026/01/23	Minor revision\|CEP granted\|23/01/2026; Minor revision\|Accepted - CEP remains valid\|02/06/2025; Notification\|Rejected\|07/05/2025; Major revision\|Accepted - CEP remains valid\|12/07/2024; Notification\|Rejected\|26/04/2024; Minor revision\|Accepted - CEP remains valid\|20/09/2023; Minor revision\|CEP granted\|26/01/2023; Minor revision\|CEP granted\|23/09/2020
2362	Rifaximin, Micronised, non-micronised	LUPIN LIMITED Mumbai IN	100004130;100015605	CEP 2020-175 - Rev 01	2026/01/23	Valid	07/12/2027	Chemical and TSE	2026/01/23	Major revision\|CEP granted\|23/01/2026; Minor revision\|Accepted - CEP remains valid\|21/06/2023; New application\|CEP granted\|07/12/2022
2773	Memantine hydrochloride	ZHEJIANG SUPOR PHARMACEUTICALS CO., LTD. Shaoxing CN	100022886;100031604	CEP 2025-311 - Rev 00	2026/01/23	Valid	23/01/2031	Chemical	2026/01/23	New application\|CEP granted\|23/01/2026
3095	Dabigatran etexilate mesilate	METROCHEM API PRIVATE LIMITED Hyderabad IN	100045158;100074519	CEP 2024-130 - Rev 00	2026/01/22	Valid	22/01/2031	Chemical	2026/01/22	New application\|CEP granted\|22/01/2026
2574	Entacapone, 1313	MACLEODS PHARMACEUTICALS LIMITED Mumbai IN	100021441;100077265	CEP 2021-051 - Rev 01	2026/01/22	Valid	21/10/2026	Chemical	2026/01/22	Minor revision\|CEP granted\|22/01/2026; Notification\|Rejected\|12/09/2022; New application\|CEP granted\|21/10/2021
203	Polymyxin B sulfate	XELLIA PHARMACEUTICALS APS Copenhagen S DK	100004144;100002734	CEP 1998-061 - Rev 06	2026/01/22	Valid		Chemical	2026/01/22	Minor revision\|CEP granted\|22/01/2026; Notification\|Accepted - CEP remains valid\|28/06/2022; Minor revision\|Accepted - CEP remains valid\|20/12/2021
2119	Venlafaxine hydrochloride, Form B	ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN	100006039;100002980	CEP 2009-270 - Rev 08	2026/01/22	Valid		Chemical	2026/01/22	Minor revision\|CEP granted\|22/01/2026; Minor revision\|Accepted - CEP remains valid\|27/08/2025; Minor revision\|Accepted - CEP remains valid\|06/09/2024; Notification\|CEP granted\|27/01/2023; Notification\|Accepted - CEP remains valid\|07/10/2021; Minor revision\|Accepted - CEP remains valid\|12/02/2021
2933	Deferasirox	MEDILUX LABORATORIES PRIVATE LIMITED Pithampur IN	100023732;100032901	CEP 2025-040 - Rev 00	2026/01/22	Valid	22/01/2031	Chemical	2026/01/22	New application\|CEP granted\|22/01/2026
2131	Tamsulosin hydrochloride	ASTELLAS PHARMA INC. Tokyo JP	100004276;100008205	CEP 2007-253 - Rev 06	2026/01/22	Valid		Chemical	2026/01/22	Notification\|CEP granted\|22/01/2026; Notification\|CEP granted\|24/10/2024; Notification\|CEP granted\|11/05/2022; Minor revision\|CEP granted\|07/06/2021
2743	Zoledronic acid monohydrate	SCINOPHARM TAIWAN, LTD. Shanhua TW	100012108;100019515	CEP 2019-281 - Rev 02	2026/01/22	Valid		Chemical	2026/01/22	Renewal\|CEP granted\|22/01/2026; Notification\|CEP granted\|16/10/2024
767	Fludrocortisone acetate, Micronised	FARMABIOS S.p.A Gropello Cairoli IT	100011643;100021232	CEP 2019-084 - Rev 02	2026/01/21	Valid		Chemical	2026/01/21	Renewal\|CEP granted\|21/01/2026; Monograph revision\|CEP granted\|01/04/2025
2574	Entacapone, Form-A, micronised, non-micronised	NEULAND LABORATORIES LIMITED Hyderabad IN	100011545;100062134	CEP 2011-191 - Rev 05	2026/01/21	Valid		Chemical	2026/01/21	Minor revision\|CEP granted\|21/01/2026; Notification\|CEP granted\|24/03/2023; Minor revision\|CEP granted\|28/09/2022; Notification\|CEP granted\|10/12/2021; Minor revision\|Accepted - CEP remains valid\|27/08/2021; Notification\|Accepted - CEP remains valid\|14/10/2020
1208	Fenbendazole for veterinary use, Process 2	SHAANXI HANJIANG PHARMACEUTICAL GROUP CO., LTD. Hanzhong CN	100012369;100079669	CEP 2018-250 - Rev 03	2026/01/21	Valid		Chemical	2026/01/21	Minor revision\|CEP granted\|21/01/2026; Renewal\|CEP granted\|22/04/2024; Minor revision\|CEP granted\|28/11/2022

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)	-