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
1593	Megestrol acetate, Micronised	XIANJU SYNSEA BIOPHA CO. LTD. Taizhou CN	100056398;100101023	CEP 2020-293 - Rev 01	2026/03/10	Valid	18/02/2027	Chemical	2026/03/10	Transfer of holdership\|CEP granted\|10/03/2026; New application\|CEP granted\|18/02/2022
2778	Sitagliptin phosphate monohydrate, Process-II	CHEMO SMS ENTERPRISE, SL Madrid ES	100038838;100060977	CEP 2025-049 - Rev 01	2026/03/10	Valid	09/05/2030	Chemical	2026/03/10	Minor revision\|CEP granted\|10/03/2026; New application\|CEP granted\|09/05/2025
1322	Fenofibrate	NOSCH LABS PRIVATE LIMITED Hyderabad IN	100020550;100089573	CEP 2024-221 - Rev 00	2026/03/10	Valid	10/03/2031	Chemical	2026/03/10	New application\|CEP granted\|10/03/2026
454	Acetazolamide, Standard and milled	ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. Starogard Gdanski PL	100000470;100001572	CEP 2010-371 - Rev 03	2026/03/10	Valid		Chemical	2026/03/10	Minor revision\|CEP granted\|10/03/2026; Minor revision\|Accepted - CEP remains valid\|07/07/2023; Major revision\|CEP granted\|04/08/2020
2086	Asparagine monohydrate	AMINO GMBH Frellstedt DE	100011599;100021107	CEP 2012-229 - Rev 02	2026/03/10	Valid		Chemical	2026/03/10	Minor revision\|CEP granted\|10/03/2026; Minor revision\|CEP granted\|08/03/2023
788	Serine, Wuming site	EVONIK REXIM (NANNING) PHARMACEUTICAL CO., LTD. Nanning CN	100019727;100082539	CEP 2014-366 - Rev 02	2026/03/10	Valid		Chemical	2026/03/10	Minor revision\|CEP granted\|10/03/2026; Notification\|CEP granted\|24/08/2023; Minor revision\|Accepted - CEP remains valid\|02/03/2023; Notification\|Rejected\|25/11/2022
1491	Amlodipine besilate, M02	MOEHS IBERICA S.L. Rubi ES	100029092;100068825	CEP 2021-359 - Rev 03	2026/03/10	Valid	08/12/2027	Chemical	2026/03/10	Monograph revision\|CEP granted\|10/03/2026; Minor revision\|CEP granted\|23/03/2023; Administrative procedure\|CEP granted\|06/01/2023; New application\|CEP granted\|08/12/2022
1250	Omega-3-acid ethyl esters 90, Containing app. 0.03% alpha tocopherol	K.D. PHARMA BEXBACH GMBH Bexbach DE	100016421;100092038	CEP 2015-118 - Rev 03	2026/03/10	Valid		Chemical	2026/03/10	Minor revision\|CEP granted\|10/03/2026; Minor revision\|CEP granted\|20/08/2024; Notification\|Accepted - CEP remains valid\|17/06/2022; Minor revision\|CEP granted\|16/11/2021; Renewal\|CEP granted\|20/10/2020; Notification\|CEP granted\|15/06/2020
2849	Hydroxychloroquine sulfate	SYMED LABS LIMITED Hyderabad IN	100018727;100090820	CEP 2025-328 - Rev 00	2026/03/10	Valid	10/03/2031	Chemical	2026/03/10	New application\|CEP granted\|10/03/2026
1658	Spectinomycin sulfate tetrahydrate for veterinary use	SHANDONG LUKANG PHARMACEUTICAL CO., LTD. Jining CN	100025471;100071013	CEP 2015-198 - Rev 01	2026/03/10	Valid		Chemical	2026/03/10	Notification\|CEP granted\|10/03/2026; Minor revision\|Accepted - CEP remains valid\|28/04/2025; Minor revision\|Accepted - CEP remains valid\|14/06/2024; Renewal\|CEP granted\|25/03/2022; Administrative procedure\|CEP granted\|12/01/2021; Minor revision\|CEP granted\|15/12/2020
1250	Omega-3-acid ethyl esters 90, Containing alpha tocopherol	K.D. PHARMA BEXBACH GMBH Bexbach DE	100016421;100092038	CEP 2009-327 - Rev 05	2026/03/10	Valid		Chemical	2026/03/10	Minor revision\|CEP granted\|10/03/2026; Minor revision\|CEP granted\|19/08/2024; Notification\|Accepted - CEP remains valid\|17/06/2022; Administrative procedure\|CEP granted\|30/11/2021; Minor revision\|CEP granted\|16/11/2021; Notification\|CEP granted\|09/06/2020
1250	Omega-3-acid ethyl esters 90, Containing mixed tocopherols	K.D. PHARMA BEXBACH GMBH Bexbach DE	100016421;100092038	CEP 2009-328 - Rev 05	2026/03/10	Valid		Chemical	2026/03/10	Minor revision\|CEP granted\|10/03/2026; Minor revision\|CEP granted\|19/08/2024; Notification\|Accepted - CEP remains valid\|17/06/2022; Minor revision\|CEP granted\|24/11/2021; Notification\|CEP granted\|11/06/2020
546	Chlortalidone, Form-I	MSN LIFE SCIENCES PRIVATE LIMITED Kamareddy IN	100018316;100070723	CEP 2024-505 - Rev 00	2026/03/10	Valid	10/03/2031	Chemical	2026/03/10	New application\|CEP granted\|10/03/2026
810	Betamethasone sodium phosphate, Process III	CURIA SPAIN S.A.U. Boecillo ES	100011649;100019586	CEP 2025-201 - Rev 01	2026/03/10	Valid	27/06/2030	Chemical	2026/03/10	Notification\|CEP granted\|10/03/2026; New application\|CEP granted\|27/06/2025
2988	Fingolimod hydrochloride, Form-I	RUYUAN HEC PHARM CO., LTD. Shaoguan CN	100023129;100031882	CEP 2019-140 - Rev 02	2026/03/10	Valid		Chemical	2026/03/10	Renewal\|CEP granted\|10/03/2026; Minor revision\|CEP granted\|25/10/2024; Monograph revision\|Accepted - CEP remains valid\|23/04/2024
943	Oxymetazoline hydrochloride	CTX LIFESCIENCES PVT. LIMITED Surat IN	100019102;100027863	CEP 2008-324 - Rev 04	2026/03/09	Valid		Chemical	2026/03/09	Minor revision\|CEP granted\|09/03/2026
1004	Diltiazem hydrochloride	CHEMECA DRUGS PRIVATE LIMITED Tadi Revenue IN	100049736;100086695	CEP 2023-401 - Rev 00	2026/03/09	Valid	09/03/2031	Chemical	2026/03/09	New application\|CEP granted\|09/03/2026
1156	Tenoxicam, Pubagang site	ZHEJIANG HENGKANG PHARMACEUTICAL CO., LTD. Sanmen CN	100034135;100082085	CEP 2025-530 - Rev 00	2026/03/09	Valid	09/03/2031	Chemical	2026/03/09	New application\|CEP granted\|09/03/2026
1491	Amlodipine besilate, TY 45	DR. REDDY'S LABORATORIES LIMITED Hyderabad IN	100003991;100000217	CEP 2025-166 - Rev 01	2026/03/09	Valid	28/07/2030	Chemical	2026/03/09	Monograph revision\|CEP granted\|09/03/2026; New application\|CEP granted\|28/07/2025
1114	Iohexol	ZHEJIANG HAIZHOU PHARMACEUTICAL CO., LTD. Linhai CN	100023844;100033013	CEP 2024-241 - Rev 00	2026/03/09	Valid	09/03/2031	Chemical	2026/03/09	New application\|CEP granted\|09/03/2026

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)	-