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
1058	Vancomycin hydrochloride	XELLIA PHARMACEUTICALS APS Copenhagen S DK	100004144;100002734	CEP 2007-195 - Rev 04	2026/04/28	Valid		Chemical	2026/04/28	Minor revision\|CEP granted\|28/04/2026; Minor revision\|CEP granted\|03/04/2025; Minor revision\|Accepted - CEP remains valid\|14/03/2024; Notification\|Accepted - CEP remains valid\|09/02/2023; Minor revision\|Accepted - CEP remains valid\|16/02/2022; Notification\|Accepted - CEP remains valid\|15/12/2020
2856	Pirfenidone	SMS PHARMACEUTICALS LIMITED Hyderabad IN	100011780;100061058	CEP 2024-559 - Rev 00	2026/04/28	Valid	28/04/2031	Chemical	2026/04/28	New application\|CEP granted\|28/04/2026
1409	Clenbuterol Hydrochloride	EDMOND PHARMA S.R.L. Paderno Dugnano IT	100000246;100002746	CEP 2012-073 - Rev 02	2026/04/28	Valid		Chemical	2026/04/28	Monograph revision\|CEP granted\|28/04/2026
889	Clomipramine Hydrochloride	SIGMA-ALDRICH IRELAND LTD Arklow IE	100019213;100027978	CEP 2008-269 - Rev 02	2026/04/28	Valid		Chemical	2026/04/28	Minor revision\|CEP granted\|28/04/2026; Minor revision\|Accepted - CEP remains valid\|19/07/2023
2574	Entacapone, Form-A, process-II	NEULAND LABORATORIES LIMITED Hyderabad IN	100011545;100062134	CEP 2026-076 - Rev 00	2026/04/28	Valid	28/04/2031	Chemical	2026/04/28	New application\|CEP granted\|28/04/2026
632	Phenylephrine hydrochloride	WUHAN WUYAO PHARMACEUTICAL CO., LTD. Huangshi CN	100022200;100030902	CEP 2024-587 - Rev 00	2026/04/28	Valid	28/04/2031	Chemical	2026/04/28	New application\|CEP granted\|28/04/2026
2905	Methane intermix (2 per cent) in nitrogen	SOL S.P.A. Monza IT	100002061;100001723	CEP 2025-504 - Rev 00	2026/04/28	Valid	28/04/2031	Chemical	2026/04/28	New application\|CEP granted\|28/04/2026
2903	Acetylene intermix (1 per cent) in nitrogen	SOL S.P.A. Monza IT	100002061;100001723	CEP 2025-626 - Rev 00	2026/04/28	Valid	28/04/2031	Chemical	2026/04/28	New application\|CEP granted\|28/04/2026
2675	Irinotecan hydrochloride trihydrate, Process-2	LAURUS LABS LIMITED Hyderabad IN	100011702;100101872	CEP 2025-394 - Rev 01	2026/04/28	Valid	14/10/2030	Chemical	2026/04/28	Minor revision\|CEP granted\|28/04/2026; New application\|CEP granted\|14/10/2025
228	Lithium carbonate	EMNAR PHARMA PRIVATE LIMITED Hyderabad IN	100033980;100065255	CEP 2026-037 - Rev 00	2026/04/28	Valid	28/04/2031	Chemical	2026/04/28	New application\|CEP granted\|28/04/2026
2644	Remifentanil hydrochloride	HAMELN RDS S.R.O. Modra SK	100000646;100003437	CEP 2018-125 - Rev 05	2026/04/24	Valid		Chemical	2026/04/24	Monograph revision\|CEP granted\|24/04/2026; Renewal\|CEP granted\|20/03/2024; Notification\|Accepted - CEP remains valid\|09/11/2021; Notification\|Accepted - CEP remains valid\|16/09/2021; Minor revision\|CEP granted\|02/06/2021; Notification\|CEP granted\|27/11/2020; Minor revision\|CEP granted\|24/03/2020
2762	Capecitabine, Process-III	INTAS PHARMACEUTICALS LIMITED Ahmedabad IN	100011529;100023432	CEP 2025-176 - Rev 01	2026/04/24	Valid	02/06/2030	Chemical	2026/04/24	Minor revision\|CEP granted\|24/04/2026; New application\|CEP granted\|02/06/2025
627	Nifedipine, S2	DIPHARMA FRANCIS S.R.L. Baranzate IT	100014675;100030401	CEP 2023-284 - Rev 01	2026/04/24	Valid	23/01/2029	Chemical	2026/04/24	Monograph revision\|CEP granted\|24/04/2026; New application\|CEP granted\|23/01/2024
916	Hydroxyzine hydrochloride	FLEMING LABORATORIES LIMITED Nawabpet Village IN	100015641;100024384	CEP 2021-436 - Rev 01	2026/04/24	Valid	08/10/2029	Chemical	2026/04/24	Monograph revision\|CEP granted\|24/04/2026; New application\|CEP granted\|08/10/2024
699	Warfarin sodium clathrate	IPCA LABORATORIES LIMITED Mumbai IN	100011685;100018680	CEP 2008-236 - Rev 03	2026/04/24	Valid		Chemical	2026/04/24	Minor revision\|CEP granted\|24/04/2026; Minor revision\|CEP granted\|15/09/2022
2598	Levofloxacin hemihydrate	ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO., LTD. Jinhua CN	100022565;100031242	CEP 2020-128 - Rev 02	2026/04/24	Valid		Chemical	2026/04/24	Renewal\|CEP granted\|24/04/2026; Minor revision\|CEP granted\|06/08/2025; Notification\|Accepted - CEP remains valid\|23/12/2024; Minor revision\|Accepted - CEP remains valid\|25/09/2024; Notification\|Abandoned\|06/07/2023; Notification\|Accepted - CEP remains valid\|17/05/2022; New application\|CEP granted\|16/07/2021
798	Fusidic acid, Sterile Powder and Sterile Micronised	ERCROS S.A. Aranjuez ES	100016091;100024873	CEP 2023-222 - Rev 01	2026/04/24	Valid	28/09/2028	Chemical	2026/04/24	Minor revision\|CEP granted\|24/04/2026; New application\|CEP granted\|28/09/2023
1008	Domperidone maleate	HALEOS LABS LIMITED Hyderabad IN	100039495;100077080	CEP 2024-131 - Rev 00	2026/04/23	Valid	23/04/2031	Chemical	2026/04/23	New application\|CEP granted\|23/04/2026
1486	Adenosine	ZHEJIANG HISUN PHARMACEUTICAL CO., LTD. Taizhou CN	100011825;100018687	CEP 2013-044 - Rev 03	2026/04/23	Valid		Chemical	2026/04/23	Notification\|CEP granted\|23/04/2026; Minor revision\|CEP granted\|06/03/2024; Minor revision\|CEP granted\|27/04/2021
2294	Tetra-O-acetyl-mannose triflate for radiopharmaceutical preparations	GE HEALTHCARE AS Oslo NO	100004019;100000539	CEP 2022-176 - Rev 01	2026/04/23	Valid	20/02/2029	Chemical	2026/04/23	Minor revision\|CEP granted\|23/04/2026; Notification\|Accepted - CEP remains valid\|12/02/2026; New application\|CEP granted\|21/02/2024

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)	-