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
1028	Metoprolol tartrate	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 1998-074 - Rev 13	2025/03/18	Valid		Chemical	2025/03/18	Notification\|CEP granted\|18/03/2025; Notification\|Accepted - CEP remains valid\|27/08/2024; Minor revision\|CEP granted\|12/03/2024; Minor revision\|CEP granted\|24/08/2023; Notification\|CEP granted\|24/03/2022; Notification\|CEP granted\|05/01/2022; Minor revision\|Accepted - CEP remains valid\|06/10/2020
573	Verapamil hydrochloride	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2006-098 - Rev 04	2025/03/18	Valid		Chemical	2025/03/18	Notification\|CEP granted\|18/03/2025; Notification\|Accepted - CEP remains valid\|03/06/2024; Notification\|CEP granted\|24/03/2022; Notification\|CEP granted\|23/02/2022
2583	Montelukast sodium	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2011-131 - Rev 03	2025/03/17	Valid		Chemical	2025/03/17	Notification\|CEP granted\|17/03/2025; Monograph revision\|Accepted - CEP remains valid\|26/11/2024; Minor revision\|CEP granted\|24/02/2022; Minor revision\|Accepted - CEP remains valid\|06/10/2020
2703	Ciclesonide	AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN	100045727;100075371	CEP 2014-090 - Rev 02	2025/03/17	Valid		Chemical	2025/03/17	Minor revision\|CEP granted\|17/03/2025; Notification\|Rejected\|30/01/2025; Notification\|CEP granted\|27/10/2022; Renewal\|CEP granted\|28/06/2021
1248	Norfloxacin, Product code 312008	KRKA TOVARNA ZDRAVIL D.D. NOVO MESTO Novo mesto SI	100000627;100009540	CEP 2021-140 - Rev 02	2025/03/17	Valid	20/12/2027	Chemical	2025/03/17	Minor revision\|CEP granted\|17/03/2025; Minor revision\|Accepted - CEP remains valid\|31/08/2023; Minor revision\|CEP granted\|28/03/2024; New application\|CEP granted\|20/12/2022
2416	Pramipexole dihydrochloride monohydrate	Boehringer Ingelheim Pharma GmbH & Co. KG Ingelheim Am Rhein DE	100000199;100004370	CEP 2019-186 - Rev 01	2025/03/17	Valid		Chemical	2025/03/17	Renewal\|CEP granted\|17/03/2025; Minor revision\|Accepted - CEP remains valid\|31/10/2023; Notification\|Accepted - CEP remains valid\|29/09/2020
3046	Pemetrexed disodium 2.5-hydrate	FARMHISPANIA S.A. Montmeló ES	100011645;100022190	CEP 2023-233 - Rev 01	2025/03/17	Valid	25/09/2029	Chemical	2025/03/17	Minor revision\|CEP granted\|17/03/2025; New application\|CEP granted\|25/09/2024
2232	Losartan potassium, Process 3	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2023-006 - Rev 01	2025/03/17	Valid	06/07/2028	Chemical	2025/05/16	Minor revision\|Accepted - CEP remains valid\|16/05/2025; Notification\|CEP granted\|17/03/2025; New application\|CEP granted\|06/07/2023
1702	Naproxen sodium	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2007-047 - Rev 06	2025/03/17	Valid		Chemical	2025/03/18	Notification\|CEP granted\|18/03/2025; Notification\|Accepted - CEP remains valid\|17/07/2024; Notification\|CEP granted\|24/03/2022; Notification\|CEP granted\|23/11/2021
1368	Ramipril, Grade A	AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN	100045727;100075371	CEP 2009-083 - Rev 06	2025/03/17	Valid		Chemical	2025/07/29	Minor revision\|Accepted - CEP remains valid\|29/07/2025; Major revision\|CEP granted\|18/03/2025; Minor revision\|Accepted - CEP remains valid\|31/08/2023; Notification\|Rejected\|27/07/2023; Notification\|CEP granted\|14/10/2022; Monograph revision\|CEP granted\|06/12/2021
1592	Ketotifen hydrogen fumarate	OLON S.P.A. Rodano IT	100012085;100019537	CEP 2012-054 - Rev 05	2025/03/17	Valid		Chemical	2025/03/18	Minor revision\|CEP granted\|18/03/2025; Minor revision\|CEP granted\|29/07/2024; Minor revision\|CEP granted\|10/06/2021
1653	Potassium clavulanate, diluted, With silicone dioxide in the ratio 1:1	SHANDONG NEW TIME PHARMACEUTICAL CO., LTD. Linyi CN	100025540;100034769	CEP 2011-376 - Rev 03	2025/03/17	Valid		Chemical	2025/03/18	Minor revision\|CEP granted\|18/03/2025; Minor revision\|Accepted - CEP remains valid\|01/03/2024; Minor revision\|Accepted - CEP remains valid\|04/10/2022; Minor revision\|CEP granted\|01/03/2021; Minor revision\|Accepted - CEP remains valid\|13/02/2020
731	Naproxen	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 1997-064 - Rev 09	2025/03/17	Valid		Chemical	2025/03/18	Notification\|CEP granted\|18/03/2025; Notification\|Accepted - CEP remains valid\|07/06/2024; Notification\|CEP granted\|24/03/2022; Notification\|CEP granted\|23/11/2021
20	Dextromethorphan hydrobromide monohydrate	MALLADI DRUGS AND PHARMACEUTICALS LIMITED Renigunta IN	100017917;100061921	CEP 2018-133 - Rev 02	2025/03/17	Valid		Chemical	2025/03/18	Renewal\|CEP granted\|18/03/2025; Monograph revision\|CEP granted\|28/06/2024
678	Sodium valproate	ASSURGEN PHARMA PVT LTD Lalamkoduru Village IN	100048048;100079469	CEP 2020-373 - Rev 01	2025/03/17	Valid	13/09/2026	Chemical	2025/03/18	Minor revision\|CEP granted\|18/03/2025; Minor revision\|Rejected\|29/10/2024; New application\|CEP granted\|13/09/2021
1491	Amlodipine besilate, Process-I	ARENE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN	100033956;100079880	CEP 2020-371 - Rev 04	2025/03/17	Valid	26/03/2026	Chemical	2025/03/18	Minor revision\|CEP granted\|18/03/2025; Minor revision\|CEP granted\|18/07/2023; Major revision\|CEP granted\|11/04/2022; Minor revision\|Rejected\|17/11/2021; Administrative procedure\|CEP granted\|08/04/2021; New application\|CEP granted\|26/03/2021
464	Amitriptyline hydrochloride	DIPHARMA FRANCIS S.R.L. Baranzate IT	100014675;100030401	CEP 2013-281 - Rev 01	2025/03/17	Valid		Chemical	2025/03/18	Minor revision\|CEP granted\|18/03/2025; Renewal\|CEP granted\|23/03/2021
673	Medroxyprogesterone acetate, Micronised, Sterile	FARMABIOS S.p.A Gropello Cairoli IT	100011643;100021232	CEP 2023-423 - Rev 00	2025/03/17	Valid	17/03/2030	Chemical	2025/03/18	New application\|CEP granted\|18/03/2025
1248	Norfloxacin, Product code 312025	KRKA TOVARNA ZDRAVIL D.D. NOVO MESTO Novo mesto SI	100000627;100009540	CEP 2021-141 - Rev 02	2025/03/17	Valid	20/12/2027	Chemical	2025/03/18	Minor revision\|CEP granted\|18/03/2025; Minor revision\|Accepted - CEP remains valid\|13/08/2024; Minor revision\|CEP granted\|06/02/2024; New application\|CEP granted\|20/12/2022
426	Polysorbate 20	KOLB DISTRIBUTION LTD. Hedingen CH	100040656;100066825	CEP 2023-322 - Rev 00	2025/03/17	Valid	17/03/2030	Chemical	2025/03/18	New application\|CEP granted\|18/03/2025

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)	-