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
2574	Entacapone, Form-A	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2012-314 - Rev 01	2025/03/24	Valid		Chemical	2025/03/24	Minor revision\|CEP granted\|24/03/2025; Minor revision\|Accepted - CEP remains valid\|22/08/2022; Minor revision\|Accepted - CEP remains valid\|13/03/2020
823	Etoposide	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 1999-144 - Rev 08	2025/03/24	Valid		Chemical	2025/03/24	Minor revision\|CEP granted\|24/03/2025; Minor revision\|Accepted - CEP remains valid\|04/03/2024; Notification\|CEP granted\|04/01/2022; Minor revision\|CEP granted\|29/06/2020
1589	Doxylamine hydrogen succinate	R L FINE CHEM PVT. LTD. Gowribidanur IN	100016723;100053383	CEP 2018-041 - Rev 03	2025/03/24	Valid		Chemical	2025/03/24	Renewal\|CEP granted\|24/03/2025; Minor revision\|CEP granted\|01/03/2024; Minor revision\|CEP granted\|10/05/2021
786	Riboflavin sodium phosphate hydrate	HARMAN FINOCHEM LIMITED Mumbai IN	100011528;100020515	CEP 2010-254 - Rev 02	2025/03/24	Valid		Chemical	2025/03/24	Monograph revision\|CEP granted\|24/03/2025; Notification\|CEP granted\|04/09/2020
1449	Mometasone furoate, Micronised, alternative process	Farmabios SpA Gropello Cairoli IT	100011643;100021232	CEP 2018-297 - Rev 04	2025/03/24	Valid		Chemical	2025/03/24	Minor revision\|CEP granted\|24/03/2025; Renewal\|CEP granted\|05/03/2025; Major revision\|CEP granted\|06/10/2023; Administrative procedure\|CEP granted\|07/09/2020
2119	Venlafaxine hydrochloride, Laurus site, Form I	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2024-557 - Rev 00	2025/03/24	Valid	24/03/2030	Chemical	2025/03/24	New application\|CEP granted\|24/03/2025
1734	Terbinafine hydrochloride, Type 2	OLON S.P.A. Rodano IT	100012085;100019537	CEP 2021-256 - Rev 02	2025/03/24	Valid	07/02/2027	Chemical	2025/03/24	Minor revision\|CEP granted\|24/03/2025; Minor revision\|CEP granted\|22/08/2023; New application\|CEP granted\|07/02/2022
1563	Simvastatin	ZHEJIANG JIANGBEI NANHAI PHARMACEUTICAL CO., LTD Linhai City CN	100049395;100084081	CEP 2022-245 - Rev 02	2025/03/24	Valid	17/05/2028	Chemical	2025/03/24	Minor revision\|CEP granted\|24/03/2025; Minor revision\|CEP granted\|03/07/2024; New application\|CEP granted\|17/05/2023
2825	Tigecycline	MELODY HEALTHCARE PVT. LTD. Mumbai IN	100014822;100073679	CEP 2018-056 - Rev 04	2025/03/24	Valid		Chemical	2025/03/24	Renewal\|CEP granted\|24/03/2025; Minor revision\|CEP granted\|23/07/2024; Minor revision\|CEP granted\|12/03/2024; Minor revision\|CEP granted\|10/10/2023; Monograph revision\|Accepted - CEP remains valid\|07/03/2022; Minor revision\|Accepted - CEP remains valid\|01/12/2021
1208	Fenbendazole for veterinary use	SEQUENT SCIENTIFIC LIMITED Mumbai IN	100017805;100032372	CEP 2004-212 - Rev 05	2025/03/21	Valid		Chemical	2025/03/21	Minor revision\|CEP granted\|21/03/2025; Minor revision\|Accepted - CEP remains valid\|22/08/2024; Monograph revision\|Accepted - CEP remains valid\|13/06/2024; Notification\|CEP granted\|30/03/2023; Minor revision\|Rejected\|30/07/2021
320	Colistin sulfate	LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN	100020920;100029633	CEP 2011-372 - Rev 04	2025/03/21	Valid		Chemical	2025/03/21	Minor revision\|CEP granted\|21/03/2025; Minor revision\|CEP granted\|03/11/2022; Notification\|Rejected\|21/09/2022; Minor revision\|CEP granted\|28/09/2021
2616	Topiramate	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2020-140 - Rev 04	2025/03/21	Valid	14/06/2027	Chemical	2025/03/21	Minor revision\|CEP granted\|21/03/2025; Notification\|CEP granted\|18/12/2023; Minor revision\|CEP granted\|28/02/2023; Minor revision\|CEP granted\|15/09/2022; New application\|CEP granted\|14/06/2022
653	Baclofen	BIOINDUSTRIA L.I.M. S.P.A. Novi Ligure IT	100001870;100092872	CEP 2011-360 - Rev 02	2025/03/21	Valid		Chemical	2025/03/21	Monograph revision\|CEP granted\|21/03/2025; Minor revision\|CEP granted\|09/09/2020
2270	Sildenafil citrate	AMOLI ORGANICS PRIVATE LIMITED Mumbai IN	100016500;100025303	CEP 2014-223 - Rev 02	2025/03/21	Valid		Chemical	2025/03/21	Major revision\|CEP granted\|21/03/2025; Minor revision\|Accepted - CEP remains valid\|02/08/2023; Minor revision\|Accepted - CEP remains valid\|09/03/2023; Minor revision\|Accepted - CEP remains valid\|24/01/2022; Major revision\|CEP granted\|04/02/2021; Renewal\|CEP granted\|29/09/2020
3115	Levocetirizine dihydrochloride	GLOCHEM INDUSTRIES PRIVATE LIMITED Hyderabad IN	100012012;100020318	CEP 2024-049 - Rev 00	2025/03/21	Valid	21/03/2030	Chemical	2025/03/21	New application\|CEP granted\|21/03/2025
1524	Gliclazide	BAL PHARMA LIMITED Bengaluru IN	100016398;100041736	CEP 2001-273 - Rev 06	2025/03/21	Valid		Chemical	2025/03/21	Notification\|CEP granted\|21/03/2025; Notification\|CEP granted\|23/10/2023; Minor revision\|CEP granted\|17/04/2023
1794	Paclitaxel, Semi-synthetic process	FRESENIUS KABI ONCOLOGY LIMITED Kalyani IN	100011513;100018607	CEP 2008-181 - Rev 11	2025/03/21	Valid		Chemical	2025/03/21	Major revision\|CEP granted\|21/03/2025; Major revision\|Accepted - CEP remains valid\|31/10/2023; Major revision\|CEP granted\|17/10/2022; Notification\|Accepted - CEP remains valid\|17/06/2022; Administrative procedure\|CEP granted\|09/05/2022; Major revision\|CEP granted\|29/04/2022; Minor revision\|Accepted - CEP remains valid\|27/11/2020; Administrative procedure\|CEP granted\|29/04/2020; Minor revision\|CEP granted\|31/03/2020
1508	Diclofenac potassium	OLON S.P.A. Rodano IT	100012085;100019537	CEP 2010-286 - Rev 05	2025/03/21	Valid		Chemical	2025/03/21	Minor revision\|CEP granted\|21/03/2025; Minor revision\|CEP granted\|24/03/2022
1081	Carboplatin	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2000-375 - Rev 05	2025/03/21	Valid		Chemical	2025/03/21	Minor revision\|CEP granted\|21/03/2025; Minor revision\|CEP granted\|13/04/2022
663	Dicloxacillin sodium, Powder and compacted	FRESENIUS KABI IPSUM S.R.L. Cassina de’ Pecchi IT	100015105;100057989	CEP 2002-036 - Rev 09	2025/03/21	Valid		Chemical	2025/03/21	Administrative procedure\|CEP granted\|21/03/2025; Notification\|CEP granted\|14/03/2025; Minor revision\|CEP granted\|16/08/2021; Notification\|CEP granted\|02/02/2021

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)	-