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
2600	Olmesartan medoxomil, Process II	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2020-112 - Rev 04	2025/05/07	Valid		Chemical	2025/05/07	Renewal\|CEP granted\|07/05/2025; Notification\|CEP granted\|11/01/2024; Minor revision\|CEP granted\|05/06/2023; Minor revision\|CEP granted\|19/08/2022; New application\|CEP granted\|31/07/2020
2330	Leflunomide	FORMOSA LABORATORIES, INC. Taoyuan TW	100011879;100018688	CEP 2009-035 - Rev 02	2025/05/05	Valid		Chemical	2025/05/12	Minor revision\|CEP granted\|12/05/2025
1335	Itraconazole	NOSCH LABS PRIVATE LIMITED Hyderabad IN	100020550;100029297	CEP 2011-283 - Rev 01	2025/05/05	Valid		Chemical	2025/05/05	Minor revision\|CEP granted\|05/05/2025; Minor revision\|Rejected\|21/02/2025
2126	Cefepime dihydrochloride monohydrate, Sterile	QILU ANTIBIOTICS PHARMACEUTICAL CO. LTD. Jinan CN	100033695;100052910	CEP 2011-286 - Rev 02	2025/05/05	Valid		Chemical	2025/05/05	Major revision\|CEP granted\|05/05/2025; Major revision\|CEP granted\|21/12/2021
2306	Gemcitabine hydrochloride	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2008-161 - Rev 03	2025/05/05	Valid		Chemical	2025/05/05	Notification\|CEP granted\|05/05/2025; Notification\|CEP granted\|20/12/2021; Notification\|Accepted - CEP remains valid\|22/02/2021
394	Hydrochlorothiazide	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2001-304 - Rev 13	2025/05/05	Valid		Chemical	2025/05/05	Minor revision\|CEP granted\|05/05/2025; Notification\|Accepted - CEP remains valid\|20/02/2023; Minor revision\|CEP granted\|03/10/2022; Minor revision\|CEP granted\|01/12/2021; Minor revision\|CEP granted\|09/12/2020
1058	Vancomycin hydrochloride	CHONGQING DAXIN PHARMACEUTICAL CO., LTD. Shuitu Town CN	100011996;100039007	CEP 2018-197 - Rev 01	2025/05/05	Valid		Chemical and TSE	2025/05/05	Renewal\|CEP granted\|05/05/2025
1551	Nomegestrol acetate, Nomac grade B	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2014-178 - Rev 06	2025/05/05	Valid		Chemical	2025/05/05	Minor revision\|CEP granted\|05/05/2025; Minor revision\|CEP granted\|25/09/2024; Notification\|CEP granted\|20/12/2021; Minor revision\|CEP granted\|22/10/2021; Minor revision\|CEP granted\|10/07/2020; Monograph revision\|CEP granted\|06/05/2020
464	Amitriptyline hydrochloride, Process II	DIPHARMA FRANCIS S.R.L. Baranzate IT	100014675;100030401	CEP 2019-193 - Rev 01	2025/05/05	Valid		Chemical	2025/05/05	Renewal\|CEP granted\|05/05/2025
658	Chlorhexidine digluconate solution, CDG	Medichem, S.A. Sant Joan Despí ES	100001017;100002951	CEP 2017-128 - Rev 01	2025/05/05	Valid		Chemical	2025/05/05	Minor revision\|CEP granted\|05/05/2025; Monograph revision\|Accepted - CEP remains valid\|26/03/2025; Minor revision\|Accepted - CEP remains valid\|13/07/2023; Renewal\|CEP granted\|18/07/2022; Notification\|Accepted - CEP remains valid\|10/06/2021; Notification\|Accepted - CEP remains valid\|07/08/2020
396	Hydrogen peroxide solution (30 per cent)	SOLVAY CHEMIE B.V. HERTEN NL	100024348;100033521	CEP 2018-167 - Rev 01	2025/05/05	Valid		Chemical	2025/05/05	Renewal\|CEP granted\|05/05/2025; Minor revision\|Accepted - CEP remains valid\|09/04/2024
2631	Rosuvastatin calcium	ZHEJIANG LEPU PHARMACEUTICAL CO., LTD Taizhou City CN	100033518;100052465	CEP 2020-243 - Rev 01	2025/05/05	Valid	31/03/2027	Chemical	2025/05/05	Minor revision\|CEP granted\|05/05/2025; New application\|CEP granted\|31/03/2022
2779	Solifenacin succinate	DIJIA PHARMACEUTICAL GROUP CO., LTD. Weihai CN	100048717;100080764	CEP 2024-479 - Rev 00	2025/05/05	Valid	05/05/2030	Chemical	2025/05/05	New application\|CEP granted\|05/05/2025
931	Metformin Hydrochloride	TRIMAX BIO SCIENCES PRIVATE LIMITED Raichur IN	100048452;100080257	CEP 2024-132 - Rev 00	2025/05/05	Valid	05/05/2030	Chemical	2025/05/05	New application\|CEP granted\|05/05/2025
67	Folic acid hydrate	Jiangxi Tianxin Pharmaceutical Co., Ltd. Leping CN	100016959;100025761	CEP 2022-378 - Rev 00	2025/05/05	Valid	05/05/2030	Chemical	2025/05/05	New application\|CEP granted\|05/05/2025
2775	Nebivolol hydrochloride	TORRENT PHARMACEUTICALS LIMITED Ahmedabad IN	100004452;100001862	CEP 2023-122 - Rev 01	2025/05/05	Valid	19/07/2029	Chemical	2025/05/05	Minor revision\|CEP granted\|05/05/2025; New application\|CEP granted\|19/07/2024
2930	Valganciclovir hydrochloride	ZHEJIANG CHARIOTEER PHARMACEUTICAL CO., LTD Xianju CN	100011826;100018693	CEP 2023-414 - Rev 00	2025/05/02	Valid	02/05/2030	Chemical	2025/05/02	New application\|CEP granted\|02/05/2025
867	Triamcinolone hexacetonide, Micronised, Sterile	Farmabios SpA Gropello Cairoli IT	100011643;100021232	CEP 2024-511 - Rev 00	2025/05/02	Valid	02/05/2030	Chemical	2025/05/02	New application\|CEP granted\|02/05/2025
1491	Amlodipine besilate, Process II	CIPLA LIMITED Mumbai IN	100006004;100018147	CEP 2015-140 - Rev 01	2025/05/02	Valid		Chemical	2025/05/02	Minor revision\|CEP granted\|02/05/2025; Minor revision\|Accepted - CEP remains valid\|24/04/2023; Renewal\|CEP granted\|16/09/2020
996	Clindamycin phosphate	HUBEI YITAI PHARMACEUTICAL CO., LTD. Tianmen CN	100039319;100061892	CEP 2022-145 - Rev 01	2025/05/02	Valid	27/05/2029	Chemical	2025/05/02	Major revision\|CEP granted\|02/05/2025; New application\|CEP granted\|27/05/2024

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)	-