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
681	Pancuronium bromide	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2009-391 - Rev 03	2025/07/08	Valid		Chemical	2025/07/08	Notification\|CEP granted\|08/07/2025; Notification\|Accepted - CEP remains valid\|30/01/2023; Notification\|CEP granted\|05/01/2022; Minor revision\|CEP granted\|07/05/2020
2781	Tolterodine tartrate	FLEMING LABORATORIES LIMITED Hyderabad IN	100015641;100067279	CEP 2022-455 - Rev 00	2025/07/08	Valid	08/07/2030	Chemical	2025/07/08	New application\|Abandoned\|08/07/2025
1653	Potassium clavulanate, diluted, with silica, colloidal hydrated in the ratio 1:1	SHANXI SHUANGYAN PHARMACEUTICAL CO., LTD. Datong CN	100052070;100091614	CEP 2024-531 - Rev 00	2025/07/08	Valid	08/07/2030	Chemical	2025/07/08	New application\|CEP granted\|08/07/2025
1653	Potassium clavulanate, diluted, with microcrystalline cellulose in the ratio 1:1	SHANXI SHUANGYAN PHARMACEUTICAL CO., LTD. Datong CN	100052070;100091614	CEP 2024-543 - Rev 00	2025/07/08	Valid	08/07/2030	Chemical	2025/07/08	New application\|CEP granted\|08/07/2025
2280	Fexofenadine hydrochloride, Form I (FXA4)	DR. REDDY'S LABORATORIES LIMITED Hyderabad IN	100003991;100000217	CEP 2025-159 - Rev 00	2025/07/08	Valid	08/07/2030	Chemical	2025/07/08	New application\|CEP granted\|08/07/2025
1590	Epirubicin hydrochloride, Lyophilised	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2003-140 - Rev 03	2025/07/07	Valid		Chemical	2025/07/07	Notification\|CEP granted\|07/07/2025; Notification\|CEP granted\|23/02/2022
1322	Fenofibrate	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2012-290 - Rev 02	2025/07/07	Valid		Chemical	2025/07/07	Minor revision\|CEP granted\|07/07/2025; Minor revision\|CEP granted\|22/06/2021
1050	Ticlopidine hydrochloride	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2001-379 - Rev 06	2025/07/07	Valid		Chemical	2025/07/07	Notification\|CEP granted\|07/07/2025; Notification\|CEP granted\|04/01/2022
1590	Epirubicin hydrochloride	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2008-040 - Rev 06	2025/07/07	Valid		Chemical	2025/07/07	Notification\|CEP granted\|07/07/2025; Notification\|CEP granted\|03/09/2024; Minor revision\|CEP granted\|05/06/2024; Notification\|Accepted - CEP remains valid\|06/06/2023; Minor revision\|CEP granted\|01/02/2022
312	Betamethasone	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2010-365 - Rev 03	2025/07/07	Valid		Chemical	2025/11/26	Major revision\|Rejected\|26/11/2025; Minor revision\|CEP granted\|07/07/2025; Notification\|CEP granted\|29/05/2024; Notification\|CEP granted\|22/11/2021; Minor revision\|Accepted - CEP remains valid\|29/09/2021
2443	Fulvestrant	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2013-255 - Rev 03	2025/07/07	Valid		Chemical	2025/07/07	Notification\|CEP granted\|07/07/2025; Minor revision\|CEP granted\|21/08/2023; Notification\|CEP granted\|10/11/2021
3014	Rotigotine	Interquim, S.A. Sant Cugat Del Vallès ES	100011698;100021071	CEP 2019-302 - Rev 02	2025/07/07	Valid	28/05/2026	Chemical	2025/07/07	Minor revision\|CEP granted\|07/07/2025; Minor revision\|CEP granted\|03/05/2024; Minor revision\|Accepted - CEP remains valid\|18/02/2022; Notification\|Rejected\|08/12/2021
2606	Tadalafil	UNICHEM LABORATORIES LIMITED Mumbai IN	100005397;100093080	CEP 2015-132 - Rev 01	2025/07/07	Valid		Chemical	2025/07/07	Major revision\|CEP granted\|07/07/2025; Renewal\|CEP granted\|07/07/2021
2857	Trazodone hydrochloride	MSN LIFE SCIENCES PRIVATE LIMITED Medak IN	100018316;100027671	CEP 2024-089 - Rev 00	2025/07/07	Valid	07/07/2030	Chemical	2025/07/07	New application\|CEP granted\|07/07/2025
685	Povidone, K12	BOAI NKY MEDICAL HOLDINGS LTD. Jiaozuo CN	100051122;100089488	CEP 2024-232 - Rev 00	2025/07/07	Valid	07/07/2030	Chemical	2025/07/07	New application\|CEP granted\|07/07/2025
627	Nifedipine	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 1999-150 - Rev 06	2025/07/04	Valid		Chemical	2025/07/04	Notification\|CEP granted\|04/07/2025; Notification\|CEP granted\|05/01/2022; Minor revision\|CEP granted\|17/06/2021
851	Pentoxifylline	SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN	100032307;100078783	CEP 2000-127 - Rev 07	2025/07/04	Valid		Chemical	2025/07/04	Major revision\|CEP granted\|04/07/2025; Monograph revision\|CEP granted\|04/06/2020
2173	Gabapentin, Butanol process	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2013-327 - Rev 03	2025/07/04	Valid		Chemical	2025/07/04	Notification\|CEP granted\|04/07/2025; Notification\|CEP granted\|28/02/2022; Minor revision\|CEP granted\|28/04/2021
2154	Telmisartan	SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN	100008538;100018201	CEP 2009-229 - Rev 02	2025/07/04	Valid		Chemical	2025/07/04	Minor revision\|CEP granted\|04/07/2025
653	Baclofen	MEDILUX LABORATORIES PRIVATE LIMITED Pithampur IN	100023732;100032901	CEP 2017-133 - Rev 02	2025/07/04	Valid		Chemical	2025/07/04	Monograph revision\|CEP granted\|04/07/2025; Renewal\|CEP granted\|19/02/2024

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)	-