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
917	Ichthammol, ICHTHYOL	OESTERREICHISCHE ICHTHYOL GES.M.B.H. & CO. KG Reith bei Seefeld AT	100022779;100079288	CEP 2025-374 - Rev 00	2025/11/12	Valid	12/11/2030	Chemical	2025/11/12	New application\|CEP granted\|12/11/2025
1751	Fosinopril sodium	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2013-018 - Rev 03	2025/11/12	Valid		Chemical	2025/11/12	Minor revision\|CEP granted\|12/11/2025; Notification\|Accepted - CEP remains valid\|14/10/2024; Minor revision\|CEP granted\|29/11/2023; Monograph revision\|CEP granted\|28/03/2022; Renewal\|CEP granted\|19/02/2021; Minor revision\|CEP granted\|25/08/2020
2577	Oxcarbazepine	ASSURGEN PHARMA PRIVATE LIMITED Lalamkoduru Village IN	100048048;100079469	CEP 2023-450 - Rev 00	2025/11/12	Valid	12/11/2030	Chemical	2025/11/12	New application\|CEP granted\|12/11/2025
546	Chlortalidone	MENADIONA, S.L. Palafolls ES	100015162;100023846	CEP 2017-285 - Rev 02	2025/11/10	Valid		Chemical	2025/11/10	Administrative procedure\|CEP granted\|10/11/2025; Renewal\|CEP granted\|05/03/2024; Monograph revision\|Accepted - CEP remains valid\|12/04/2022
1649	Azithromycin	ANUH PHARMA LTD. Mumbai IN	100021566;100030259	CEP 2021-143 - Rev 02	2025/11/10	Valid	13/07/2028	Chemical	2025/11/10	Administrative procedure\|CEP granted\|10/11/2025; Minor revision\|CEP granted\|22/01/2025; New application\|CEP granted\|13/07/2023
1734	Terbinafine hydrochloride	QUIMICA SINTETICA S.A. Alcala De Henares ES	100012121;100019020	CEP 2012-269 - Rev 02	2025/11/10	Valid		Chemical	2025/11/10	Minor revision\|CEP granted\|10/11/2025
3137	Dapagliflozin propylene glycol monohydrate	KRKA TOVARNA ZDRAVIL D.D. NOVO MESTO Novo mesto SI	100000627;100009540	CEP 2025-193 - Rev 00	2025/11/10	Valid	10/11/2030	Chemical	2025/11/10	New application\|CEP granted\|10/11/2025
274	Erythromycin ethylsuccinate, Powder, micronised	ERCROS S.A. Aranjuez ES	100016091;100024873	CEP 2002-136 - Rev 09	2025/11/10	Valid		Chemical	2025/11/10	Administrative procedure\|CEP granted\|10/11/2025; Minor revision\|CEP granted\|02/12/2024
179	Erythromycin	ANUH PHARMA LTD. Mumbai IN	100021566;100030259	CEP 2005-205 - Rev 13	2025/11/10	Valid		Chemical	2025/11/10	Administrative procedure\|CEP granted\|10/11/2025; Notification\|CEP granted\|08/07/2025; Notification\|Accepted - CEP remains valid\|23/12/2024; Notification\|CEP granted\|14/09/2023; Minor revision\|CEP granted\|10/08/2023; Minor revision\|CEP granted\|30/08/2022; Monograph revision\|Accepted - CEP remains valid\|22/02/2021; Notification\|CEP granted\|30/06/2020; Notification\|CEP granted\|26/02/2020
227	Lidocaine hydrochloride monohydrate	SHANDONG CHENGHUI SHUANGDA PHARMACEUTICAL CO., LTD. Dezhou City CN	100048410;100080174	CEP 2024-340 - Rev 00	2025/11/10	Valid	10/11/2030	Chemical	2025/11/10	New application\|CEP granted\|10/11/2025
101	Nitrofurantoin, Macrocrystals	MANKIND PHARMA LIMITED New Delhi IN	100040218;100065486	CEP 2019-092 - Rev 04	2025/11/10	Valid		Chemical	2025/11/10	Minor revision\|CEP granted\|10/11/2025; Renewal\|CEP granted\|18/06/2025; Administrative procedure\|CEP granted\|12/10/2023; Minor revision\|CEP granted\|28/09/2023; Minor revision\|Accepted - CEP remains valid\|09/08/2023; Minor revision\|Accepted - CEP remains valid\|19/08/2021; Minor revision\|Accepted - CEP remains valid\|14/04/2021
2423	Valsartan, Essential Amorphous Form, Process-II	DR. REDDY'S LABORATORIES LIMITED Hyderabad IN	100003991;100000217	CEP 2025-449 - Rev 00	2025/11/10	Valid	10/11/2030	Chemical	2025/11/10	New application\|CEP granted\|10/11/2025
193	Sodium chloride	K+S MINERALS AND AGRICULTURE GMBH Kassel DE	100020039;100051870	CEP 2007-367 - Rev 04	2025/11/10	Valid		Chemical	2025/11/10	Minor revision\|CEP granted\|10/11/2025; Minor revision\|CEP granted\|15/07/2024; Minor revision\|Accepted - CEP remains valid\|24/04/2023; Minor revision\|Accepted - CEP remains valid\|13/06/2022; Minor revision\|Accepted - CEP remains valid\|24/02/2021
3049	Etonogestrel	INDUSTRIALE CHIMICA S.R.L. Saronno IT	100011692;100020331	CEP 2025-195 - Rev 00	2025/11/10	Valid	10/11/2030	Chemical	2025/11/10	New application\|CEP granted\|10/11/2025
2019	Perindopril tert-butylamine, Process 2, Micronised and Non-micronised	ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN	100011833;100018698	CEP 2020-356 - Rev 01	2025/11/10	Valid		Chemical	2025/11/10	Renewal\|CEP granted\|10/11/2025; Notification\|Accepted - CEP remains valid\|03/09/2024; Minor revision\|Accepted - CEP remains valid\|28/11/2022; Minor revision\|Accepted - CEP remains valid\|22/02/2022; New application\|CEP granted\|24/02/2021
3095	Dabigatran etexilate mesilate	ZHEJIANG TIANYU PHARMACEUTICAL CO., LTD. Taizhou City CN	100012174;100018701	CEP 2024-073 - Rev 01	2025/11/06	Valid	19/08/2030	Chemical	2025/11/06	Minor revision\|CEP granted\|06/11/2025; New application\|CEP granted\|19/08/2025
883	Calcitriol	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 1998-055 - Rev 09	2025/11/06	Valid		Chemical	2025/11/06	Notification\|CEP granted\|06/11/2025; Minor revision\|CEP granted\|25/04/2025; Monograph revision\|Accepted - CEP remains valid\|26/11/2024; Minor revision\|CEP granted\|16/08/2024; Notification\|Rejected\|06/06/2024; Notification\|Accepted - CEP remains valid\|06/06/2023; Minor revision\|Accepted - CEP remains valid\|21/04/2022; Notification\|CEP granted\|20/12/2021; Minor revision\|CEP granted\|09/06/2021
2825	Tigecycline	ZHEJIANG HISUN PHARMACEUTICAL CO., LTD. Taizhou City CN	100011825;100018687	CEP 2024-176 - Rev 01	2025/11/06	Valid	10/09/2030	Chemical	2025/11/06	Notification\|CEP granted\|06/11/2025; New application\|CEP granted\|10/09/2025
2124	Loratadine	VASUDHA PHARMA CHEM LIMITED Hyderabad IN	100011811;100018603	CEP 2009-009 - Rev 04	2025/11/05	Valid		Chemical	2025/11/05	Minor revision\|CEP granted\|05/11/2025; Notification\|CEP granted\|30/01/2023; Minor revision\|Accepted - CEP remains valid\|12/12/2022; Notification\|Accepted - CEP remains valid\|20/09/2021; Minor revision\|CEP granted\|12/10/2020
967	Acetylcysteine	ZHEJIANG CDMO PHARMACEUTICAL CO., LTD Jinhua CN	100051857;100091157	CEP 2024-393 - Rev 00	2025/11/05	Valid	05/11/2030	Chemical	2025/11/05	New application\|CEP granted\|05/11/2025

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)	-