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
796	Valine	EVONIK REXIM (NANNING) PHARMACEUTICAL CO., LTD. Nanning CN	100019727;100082539	CEP 2008-128 - Rev 04	2025/08/28	Valid		Chemical	2025/08/28	Minor revision\|CEP granted\|28/08/2025; Notification\|Accepted - CEP remains valid\|02/01/2024; Notification\|CEP granted\|24/08/2023; Minor revision\|Accepted - CEP remains valid\|20/07/2022
919	Ipratropium bromide	NEULAND LABORATORIES LIMITED Hyderabad IN	100011545;100062134	CEP 2012-126 - Rev 03	2025/08/28	Valid		Chemical	2025/08/28	Minor revision\|CEP granted\|28/08/2025; Minor revision\|Accepted - CEP remains valid\|29/11/2024; Minor revision\|Accepted - CEP remains valid\|19/06/2024; Minor revision\|CEP granted\|14/04/2023; Notification\|CEP granted\|07/09/2021
1563	Simvastatin, BHA process	SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN	100023303;100032437	CEP 2017-184 - Rev 04	2025/08/28	Valid		Chemical	2025/08/28	Minor revision\|CEP granted\|28/08/2025; Renewal\|CEP granted\|12/03/2024; Minor revision\|CEP granted\|12/10/2023
2372	Esomeprazole magnesium trihydrate	GRANULES INDIA LIMITED Hyderabad IN	100011671;100097387	CEP 2022-012 - Rev 03	2025/08/28	Valid	30/11/2027	Chemical	2025/08/28	Notification\|CEP granted\|28/08/2025; Minor revision\|CEP granted\|13/12/2024; Notification\|CEP granted\|06/06/2024; New application\|CEP granted\|01/12/2022
2857	Trazodone hydrochloride	GRANULES INDIA LIMITED Hyderabad IN	100011671;100097387	CEP 2023-010 - Rev 01	2025/08/28	Valid	15/02/2029	Chemical	2025/08/28	Notification\|CEP granted\|28/08/2025; New application\|CEP granted\|15/02/2024
2761	Bupivacaine	CAMBREX KARLSKOGA AB Karlskoga SE	100011979;100018302	CEP 2025-114 - Rev 00	2025/08/28	Valid	28/08/2030	Chemical	2025/08/28	New application\|CEP granted\|28/08/2025
2254	Moxifloxacin hydrochloride, Monohydrate	MACLEODS PHARMACEUTICALS LIMITED Mumbai IN	100021441;100077265	CEP 2015-269 - Rev 03	2025/08/28	Valid		Chemical	2025/08/28	Minor revision\|CEP granted\|28/08/2025; Notification\|Rejected\|04/07/2025; Notification\|CEP granted\|25/01/2024; Minor revision\|Abandoned\|22/01/2024; Minor revision\|CEP granted\|20/06/2023; Renewal\|CEP granted\|27/07/2022; Minor revision\|CEP granted\|29/03/2021; Minor revision\|Accepted - CEP remains valid\|23/06/2020
1695	Granisetron hydrochloride, Site II	ORBION PHARMACEUTICALS PRIVATE LIMITED Irungattukottai IN	100042538;100070307	CEP 2020-006 - Rev 02	2025/08/27	Valid		Chemical	2025/08/27	Renewal\|CEP granted\|27/08/2025; Transfer of holdership\|CEP granted\|13/04/2022; New application\|CEP granted\|26/11/2020
1524	Gliclazide	GRANULES INDIA LIMITED Hyderabad IN	100011671;100097387	CEP 2017-240 - Rev 03	2025/08/27	Valid		Chemical	2025/08/27	Notification\|CEP granted\|27/08/2025; Renewal\|CEP granted\|14/10/2024; Minor revision\|CEP granted\|03/01/2022
1590	Epirubicin hydrochloride, Crystalline	TRANSO-PHARM HANDELS GMBH Siek DE	100018331;100027110	CEP 2020-294 - Rev 01	2025/08/27	Valid		Chemical	2025/08/27	Renewal\|CEP granted\|27/08/2025; Notification\|Accepted - CEP remains valid\|22/08/2022; New application\|CEP granted\|15/12/2020
912	Hyaluronidase	BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI S.P.A. Novi Ligure IT	100001870;100092872	CEP 2001-068 - Rev 01	2025/08/27	Valid		TSE	2025/08/27	Administrative procedure\|CEP granted\|27/08/2025
1120	Lisinopril dihydrate	ZHEJIANG CHANGMING PHARMACEUTICAL CO., LTD. Taizhou CN	100022703;100031392	CEP 2011-002 - Rev 01	2025/08/27	Valid		Chemical	2025/08/27	Minor revision\|CEP granted\|27/08/2025; Notification\|Accepted - CEP remains valid\|12/06/2024; Notification\|Accepted - CEP remains valid\|21/06/2023; Minor revision\|Accepted - CEP remains valid\|29/07/2021; Notification\|Accepted - CEP remains valid\|19/02/2020
1555	Pergolide mesilate	Chemwerth, Inc. Woodbridge US	100025547;100034778	CEP 2024-192 - Rev 00	2025/08/27	Valid	27/08/2030	Chemical	2025/08/27	New application\|CEP granted\|27/08/2025
931	Metformin Hydrochloride, Unit-IV Site	GRANULES INDIA LIMITED Hyderabad IN	100011671;100097387	CEP 2021-312 - Rev 02	2025/08/27	Valid	18/01/2027	Chemical	2025/08/27	Notification\|CEP granted\|27/08/2025; Major revision\|CEP granted\|25/11/2024; New application\|CEP granted\|18/01/2022
2362	Rifaximin, [RSA code] Process-II	GRANULES INDIA LIMITED Hyderabad IN	100011671;100097387	CEP 2021-377 - Rev 02	2025/08/27	Valid	16/02/2028	Chemical	2025/08/27	Notification\|CEP granted\|27/08/2025; Notification\|CEP granted\|11/06/2024; New application\|CEP granted\|16/02/2023
2359	Dorzolamide hydrochloride	SHOBHA LIFE SCIENCES PRIVATE LIMITED Chityala IN	100053662;100094893	CEP 2025-065 - Rev 00	2025/08/27	Valid	27/08/2030	Chemical	2025/08/27	New application\|CEP granted\|27/08/2025
2232	Losartan potassium, Process II, Form-I	GRANULES INDIA LIMITED Hyderabad IN	100011671;100097387	CEP 2020-333 - Rev 05	2025/08/27	Valid		Chemical	2025/11/19	Renewal\|Accepted - CEP remains valid\|19/11/2025; Notification\|CEP granted\|27/08/2025; Minor revision\|CEP granted\|25/06/2025; Notification\|CEP granted\|10/06/2024; Minor revision\|CEP granted\|09/11/2023; Minor revision\|Accepted - CEP remains valid\|08/09/2022; Minor revision\|CEP granted\|09/12/2021; New application\|CEP granted\|11/02/2021
615	Guaifenesin	GRANULES INDIA LIMITED Hyderabad IN	100011671;100097387	CEP 2009-201 - Rev 04	2025/08/25	Valid		Chemical	2025/08/25	Notification\|CEP granted\|25/08/2025; Minor revision\|Accepted - CEP remains valid\|21/06/2022; Notification\|Accepted - CEP remains valid\|02/03/2021
1290	Amikacin sulfate	SHANDONG ANXIN PHARMACEUTICAL CO., LTD Jinan CN	100012114;100052387	CEP 2010-308 - Rev 02	2025/08/25	Valid		Chemical	2025/08/25	Minor revision\|CEP granted\|25/08/2025; Minor revision\|Accepted - CEP remains valid\|04/02/2021; Notification\|Accepted - CEP remains valid\|18/06/2020
931	Metformin Hydrochloride	GRANULES INDIA LIMITED Hyderabad IN	100011671;100097387	CEP 2004-124 - Rev 08	2025/08/25	Valid		Chemical	2025/08/25	Notification\|CEP granted\|25/08/2025; Minor revision\|Accepted - CEP remains valid\|05/02/2025; Minor revision\|CEP granted\|05/05/2023; Minor revision\|CEP granted\|12/07/2021; Minor revision\|Accepted - CEP remains valid\|26/06/2020; Monograph revision\|Accepted - CEP remains valid\|25/03/2020

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)	-