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
2229	Enrofloxacin for veterinary use, Process II	MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN	100051463;100098142	CEP 2023-424 - Rev 02	2025/09/24	Valid	14/02/2029	Chemical	2025/09/24	Notification\|CEP granted\|24/09/2025; Notification\|CEP granted\|29/07/2024; New application\|CEP granted\|14/02/2024
1250	Omega-3-acid ethyl esters 90, With alpha-tocopherol 2	SHANDONG TENMORE TRADING CO., LTD. Linyi CN	100051725;100090854	CEP 2025-341 - Rev 00	2025/09/24	Valid	24/09/2030	Chemical	2025/09/24	New application\|CEP granted\|24/09/2025
2125	Doxazosin mesilate	NIFTY LABS PRIVATE LIMITED Hyderabad IN	100014767;100042749	CEP 2022-257 - Rev 01	2025/09/24	Valid	15/04/2029	Chemical	2025/09/24	Notification\|CEP granted\|24/09/2025; New application\|CEP granted\|15/04/2024
2932	Rivaroxaban	NIFTY LABS PRIVATE LIMITED Hyderabad IN	100014767;100042749	CEP 2022-375 - Rev 01	2025/09/24	Valid	17/05/2029	Chemical	2025/09/24	Notification\|CEP granted\|24/09/2025; New application\|CEP granted\|17/05/2024
2541	Quetiapine Fumarate, Process II	NIFTY LABS PRIVATE LIMITED Hyderabad IN	100014767;100042749	CEP 2021-289 - Rev 04	2025/09/24	Valid	01/04/2027	Chemical	2025/09/24	Notification\|CEP granted\|24/09/2025; Minor revision\|CEP granted\|14/05/2024; Minor revision\|CEP granted\|15/06/2023; Notification\|CEP granted\|16/08/2022; New application\|CEP granted\|01/04/2022
253	Ascorbic acid	Luwei Pharmaceutical Group Co., Ltd Zibo CN	100049996;100087293	CEP 2023-408 - Rev 00	2025/09/24	Valid	24/09/2030	Chemical and TSE	2025/09/24	New application\|CEP granted\|24/09/2025
2230	Latanoprost	CAYMAN PHARMA S.R.O. Neratovice CZ	100013822;100019767	CEP 2023-147 - Rev 01	2025/09/23	Valid	10/06/2030	Chemical	2025/09/23	Administrative procedure\|CEP granted\|23/09/2025; New application\|CEP granted\|10/06/2025
2787	Esomeprazole magnesium dihydrate, Micronised 1 and Micronised 2	CIPLA LIMITED Mumbai IN	100006004;100018147	CEP 2014-077 - Rev 02	2025/09/23	Valid		Chemical	2025/09/23	Minor revision\|CEP granted\|23/09/2025; Minor revision\|CEP granted\|21/11/2024; Renewal\|CEP granted\|26/08/2021
2616	Topiramate	ZYDUS LIFESCIENCES LIMITED Vadodara IN	100005979;100074301	CEP 2021-419 - Rev 02	2025/09/23	Valid	24/03/2028	Chemical	2025/09/23	Minor revision\|CEP granted\|23/09/2025; Minor revision\|CEP granted\|10/10/2024; New application\|CEP granted\|24/03/2023
2600	Olmesartan medoxomil	MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN	100051463;100098142	CEP 2012-043 - Rev 05	2025/09/23	Valid		Chemical	2025/09/23	Notification\|CEP granted\|23/09/2025; Notification\|CEP granted\|22/07/2024; Notification\|CEP granted\|01/09/2021; Major revision\|CEP granted\|02/11/2020
2787	Esomeprazole magnesium dihydrate, Micronised, non-micronised	MINAKEM Dunkerque FR	100032366;100056463	CEP 2015-086 - Rev 01	2025/09/22	Valid		Chemical	2025/09/22	Major revision\|CEP granted\|22/09/2025; Notification\|Accepted - CEP remains valid\|15/11/2024; Minor revision\|Accepted - CEP remains valid\|20/12/2023; Minor revision\|Accepted - CEP remains valid\|15/07/2022; Minor revision\|Accepted - CEP remains valid\|26/05/2021; Renewal\|CEP granted\|31/08/2020
1563	Simvastatin, Ethanol process	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2010-130 - Rev 06	2025/09/22	Valid		Chemical	2025/09/22	Notification\|CEP granted\|22/09/2025; Notification\|CEP granted\|20/12/2021
929	Loperamide hydrochloride, Micronised	LAKE CHEMICALS PRIVATE LIMITED Bengaluru IN	100012055;100053935	CEP 2009-362 - Rev 03	2025/09/22	Valid		Chemical	2025/09/22	Minor revision\|CEP granted\|22/09/2025; Notification\|CEP granted\|14/02/2023
2675	Irinotecan hydrochloride trihydrate	QILU PHARMACEUTICAL CO., LTD. Jinan CN	100014051;100061315	CEP 2016-276 - Rev 02	2025/09/22	Valid		Chemical	2025/09/22	Major revision\|CEP granted\|22/09/2025; Minor revision\|Accepted - CEP remains valid\|31/01/2025; Minor revision\|CEP granted\|26/06/2024; Minor revision\|Accepted - CEP remains valid\|26/02/2024; Renewal\|CEP granted\|25/08/2022; Notification\|Accepted - CEP remains valid\|28/01/2022; Notification\|Accepted - CEP remains valid\|10/11/2021; Notification\|CEP granted\|16/09/2021; Minor revision\|CEP granted\|19/06/2020
2423	Valsartan	IPCA LABORATORIES LIMITED Mumbai IN	100011685;100018680	CEP 2010-100 - Rev 06	2025/09/22	Valid		Chemical	2025/09/22	Minor revision\|CEP granted\|22/09/2025; Minor revision\|CEP granted\|18/11/2022; Minor revision\|Accepted - CEP remains valid\|15/06/2022; Minor revision\|CEP granted\|01/12/2020; Minor revision\|Accepted - CEP remains valid\|19/05/2020
1442	Leuprorelin	CHEMI S.P.A. Patrica IT	100000347;100009242	CEP 2008-115 - Rev 05	2025/09/22	Valid		Chemical	2025/09/22	Minor revision\|CEP granted\|22/09/2025; Minor revision\|CEP granted\|10/03/2022; Notification\|Rejected\|30/11/2021; Minor revision\|Accepted - CEP remains valid\|28/05/2020
533	Triamcinolone acetonide	AVIK PHARMACEUTICAL LIMITED Vapi IN	100023327;100041968	CEP 2018-231 - Rev 01	2025/09/22	Valid		Chemical	2025/09/22	Renewal\|CEP granted\|22/09/2025; Notification\|Accepted - CEP remains valid\|17/06/2022
687	Salbutamol sulfate, Micronised	MELODY HEALTHCARE PRIVATE LIMITED Mumbai IN	100014822;100073679	CEP 2020-063 - Rev 03	2025/09/22	Valid		Chemical	2025/09/22	Renewal\|CEP granted\|22/09/2025; Monograph revision\|CEP granted\|25/03/2024; Minor revision\|CEP granted\|23/03/2022; New application\|CEP granted\|21/10/2020
2333	Fluvastatin sodium, Crystalline-2	BIOCON LIMITED Bengaluru IN	100011487;100018595	CEP 2022-130 - Rev 02	2025/09/22	Valid	15/06/2027	Chemical	2025/09/22	Minor revision\|CEP granted\|22/09/2025; Administrative procedure\|CEP granted\|23/06/2022; New application\|CEP granted\|15/06/2022
1300	Cefuroxime axetil, Amorphous	TITAN PHARMACEUTICAL CO., LTD. (GUANGDONG) Heyuan City CN	100024682;100033865	CEP 2017-034 - Rev 01	2025/09/22	Valid		Chemical	2025/09/22	Minor revision\|CEP granted\|22/09/2025; Renewal\|CEP granted\|20/04/2023; Minor revision\|CEP granted\|02/09/2021; Minor revision\|CEP granted\|23/04/2021

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)	-