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
.	Foetal Bovine Serum	GLOBAL LIFE SCIENCES SOLUTIONS NEW ZEALAND Tauranga NZ	100052523;100092494	CEP 2000-384 - Rev 06	2025/04/10	Valid		TSE	2025/04/10	Notification\|CEP granted\|10/04/2025; Major revision\|CEP granted\|22/02/2023; Notification\|Accepted - CEP remains valid\|05/12/2022; Major revision\|CEP granted\|29/04/2022; Notification\|Rejected\|07/03/2022; Notification\|Accepted - CEP remains valid\|28/07/2021; Notification\|Accepted - CEP remains valid\|04/05/2021; Notification\|CEP granted\|05/06/2020
2004	Sotalol hydrochloride	NEULAND LABORATORIES LIMITED Hyderabad IN	100011545;100062134	CEP 2001-269 - Rev 10	2025/04/10	Valid		Chemical	2025/04/10	Minor revision\|CEP granted\|10/04/2025; Monograph revision\|CEP granted\|06/03/2024; Minor revision\|Accepted - CEP remains valid\|04/07/2023; Notification\|CEP granted\|29/03/2023; Notification\|CEP granted\|06/12/2021; Minor revision\|Accepted - CEP remains valid\|09/09/2021
578	Ampicillin sodium, Sterile and bacterial endotoxins free	ACS DOBFAR S.P.A. Tribiano IT	100011589;100019524	CEP 2004-303 - Rev 05	2025/04/10	Valid		Chemical	2025/04/10	Administrative procedure\|CEP granted\|10/04/2025; Minor revision\|CEP granted\|25/03/2025; Minor revision\|CEP granted\|24/01/2024; Major revision\|CEP granted\|04/12/2020
2779	Solifenacin succinate	ALIVUS LIFE SCIENCES LIMITED Mumbai IN	100023468;100069944	CEP 2017-249 - Rev 03	2025/04/09	Valid		Chemical	2025/04/09	Notification\|CEP granted\|09/04/2025; Renewal\|Accepted - CEP remains valid\|17/09/2024; Minor revision\|CEP granted\|04/04/2024; Notification\|CEP granted\|02/12/2022; Minor revision\|Accepted - CEP remains valid\|23/04/2021
316	Cellulose, microcrystalline	INTERNATIONAL N&H USA, INC Newark US	100051090;100089421	CEP 2000-184 - Rev 04	2025/04/09	Valid		Chemical	2025/04/09	Transfer of holdership\|CEP granted\|09/04/2025; Minor revision\|CEP granted\|08/03/2024; Notification\|Abandoned\|08/09/2020
2606	Tadalafil, D150 process	ALIVUS LIFE SCIENCES LIMITED Mumbai IN	100023468;100069944	CEP 2016-040 - Rev 01	2025/04/09	Valid		Chemical	2025/04/09	Notification\|CEP granted\|09/04/2025; Renewal\|CEP granted\|29/06/2022; Minor revision\|CEP granted\|29/06/2020
2154	Telmisartan	ALIVUS LIFE SCIENCES LIMITED Mumbai IN	100023468;100069944	CEP 2009-028 - Rev 07	2025/04/09	Valid		Chemical	2025/04/09	Notification\|CEP granted\|09/04/2025; Notification\|CEP granted\|06/12/2022; Administrative procedure\|CEP granted\|04/03/2022; Major revision\|CEP granted\|25/02/2022; Minor revision\|Rejected\|25/11/2021
625	Sodium alginate	IFF N&H NORWAY AS Vormedal NO	100029391;100046689	CEP 2014-341 - Rev 02	2025/04/09	Valid		Chemical	2025/04/09	Transfer of holdership\|CEP granted\|09/04/2025; Minor revision\|CEP granted\|19/04/2024; Renewal\|CEP granted\|05/07/2022; Notification\|Abandoned\|15/10/2021
2598	Levofloxacin hemihydrate	DR. REDDY'S LABORATORIES LIMITED Hyderabad IN	100003991;100000217	CEP 2019-059 - Rev 02	2025/04/08	Valid		Chemical	2025/12/10	Notification\|Accepted - CEP remains valid\|10/12/2025; Renewal\|CEP granted\|08/04/2025; Minor revision\|Accepted - CEP remains valid\|25/06/2024; Major revision\|CEP granted\|21/12/2021
553	Ethambutol hydrochloride	MICRO LABS LIMITED Bengaluru IN	100017819;100077269	CEP 2016-060 - Rev 01	2025/04/08	Valid		Chemical	2025/04/08	Minor revision\|CEP granted\|08/04/2025; Renewal\|CEP granted\|12/09/2022
549	Dexamethasone sodium phosphate	XI’AN GUOKANG RUIJIN PHARMACEUTICAL CO., LTD. Xi’an City CN	100039231;100096104	CEP 2023-042 - Rev 00	2025/04/08	Valid	08/04/2030	Chemical	2025/04/08	New application\|CEP granted\|08/04/2025
1104	Fluoxetine hydrochloride	IPCA LABORATORIES LIMITED Mumbai IN	100011685;100018680	CEP 2023-400 - Rev 00	2025/04/08	Valid	08/04/2030	Chemical	2025/04/08	New application\|CEP granted\|08/04/2025
2777	Pregabalin	ENANTI LABS PRIVATE LIMITED Anakapalli District IN	100047758;100078940	CEP 2023-199 - Rev 00	2025/04/08	Valid	08/04/2030	Chemical	2025/04/08	New application\|CEP granted\|08/04/2025
2423	Valsartan	CPL PHARMACEUTICALS PRIVATE LIMITED Ahmedabad IN	100048075;100079517	CEP 2023-282 - Rev 00	2025/04/08	Valid	08/04/2030	Chemical	2025/04/08	New application\|CEP granted\|08/04/2025
2196	Bicalutamide, Form-H1	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2012-254 - Rev 03	2025/04/07	Valid		Chemical	2025/04/07	Minor revision\|CEP granted\|07/04/2025; Minor revision\|Accepted - CEP remains valid\|11/08/2023; Minor revision\|CEP granted\|09/01/2023; Minor revision\|Accepted - CEP remains valid\|16/03/2022; Notification\|Rejected\|17/01/2022; Minor revision\|CEP granted\|29/06/2020
2787	Esomeprazole magnesium dihydrate	ALIVUS LIFE SCIENCES LIMITED Mumbai IN	100023468;100069944	CEP 2014-258 - Rev 03	2025/04/07	Valid		Chemical	2025/04/07	Notification\|CEP granted\|07/04/2025; Minor revision\|Accepted - CEP remains valid\|26/02/2024; Minor revision\|CEP granted\|09/02/2023; Notification\|CEP granted\|06/12/2022; Renewal\|CEP granted\|02/12/2020; Minor revision\|CEP granted\|24/06/2020
2017	Oxaliplatin, Process HER-1	HERAEUS PRECIOUS METALS GMBH & CO. KG Hanau DE	100012310;100021629	CEP 2003-278 - Rev 09	2025/04/07	Valid		Chemical	2025/04/07	Notification\|CEP granted\|07/04/2025; Notification\|CEP granted\|02/10/2023; Notification\|CEP granted\|07/07/2022; Notification\|Accepted - CEP remains valid\|03/06/2021; Minor revision\|CEP granted\|26/03/2021
816	Cinnarizine	FDC Limited Mumbai IN	100011646;100021030	CEP 2003-150 - Rev 04	2025/04/07	Valid		Chemical	2025/04/07	Monograph revision\|CEP granted\|07/04/2025; Minor revision\|CEP granted\|08/09/2023; Minor revision\|Accepted - CEP remains valid\|21/07/2022
2856	Pirfenidone, micronised, non-micronised	SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN	100044578;100073706	CEP 2016-242 - Rev 01	2025/04/07	Valid		Chemical	2025/04/07	Minor revision\|CEP granted\|07/04/2025; Renewal\|CEP granted\|03/10/2022; Minor revision\|CEP granted\|20/08/2021
1722	Flunarizine dihydrochloride	VASUDHA PHARMA CHEM LIMITED Hyderabad IN	100011811;100018603	CEP 2020-224 - Rev 04	2025/04/07	Valid	01/02/2027	Chemical	2025/04/07	Minor revision\|CEP granted\|07/04/2025; Monograph revision\|CEP granted\|18/08/2023; Notification\|CEP granted\|03/02/2023; Minor revision\|CEP granted\|06/07/2022; New application\|CEP granted\|01/02/2022

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)	-