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
2606	Tadalafil	RAKSHIT PHARMACEUTICALS LIMITED Anakapalli District IN	100039283;100061839	CEP 2016-317 - Rev 01	2025/05/27	Valid		Chemical	2025/05/27	Minor revision\|CEP granted\|27/05/2025; Renewal\|CEP granted\|17/08/2023; Notification\|CEP granted\|11/01/2023; Minor revision\|Accepted - CEP remains valid\|13/04/2021
2182	Trimebutine maleate	MOEHS IBERICA S.L. Rubi ES	100029092;100068825	CEP 2011-170 - Rev 02	2025/05/27	Valid		Chemical	2025/05/27	Minor revision\|CEP granted\|27/05/2025
2445	Adapalene, Micronised and non-micronised	OLON S.P.A. Rodano IT	100012085;100019537	CEP 2022-259 - Rev 02	2025/05/27	Valid	28/07/2028	Chemical	2025/05/27	Administrative procedure\|CEP granted\|27/05/2025; Minor revision\|CEP granted\|25/04/2025; New application\|CEP granted\|28/07/2023
2101	Tetryzoline hydrochloride	PCAS Ecully FR	100011754;100054740	CEP 2019-180 - Rev 01	2025/05/27	Valid	28/09/2026	Chemical	2025/05/27	Minor revision\|CEP granted\|27/05/2025
1551	Nomegestrol acetate	INDUSTRIALE CHIMICA S.R.L. Saronno IT	100011692;100020331	CEP 2019-038 - Rev 02	2025/05/27	Valid		Chemical	2025/05/27	Renewal\|CEP granted\|27/05/2025; Notification\|Accepted - CEP remains valid\|13/06/2023; Notification\|Rejected\|17/05/2023; Minor revision\|CEP granted\|01/04/2021
1270	Terconazole	NOSCH LABS PRIVATE LIMITED Hyderabad IN	100020550;100029297	CEP 2022-298 - Rev 01	2025/05/27	Valid	13/11/2029	Chemical	2025/05/27	Minor revision\|CEP granted\|27/05/2025; New application\|CEP granted\|13/11/2024
2765	Eplerenone	ZHEJIANG ACINOVA PHARMACEUTICAL CO., LTD. Taizhou CN	100054484;100096546	CEP 2017-276 - Rev 03	2025/05/27	Valid		Chemical	2025/05/27	Notification\|CEP granted\|27/05/2025; Renewal\|CEP granted\|27/05/2024; Minor revision\|CEP granted\|09/07/2021
388	Dexamethasone	BHAGERIA & JAJODIA PHARMACEUTICALS PRIVATE LIMITED Vapi IN	100050824;100088833	CEP 2024-138 - Rev 00	2025/05/27	Valid	27/05/2030	Chemical	2025/05/27	New application\|CEP granted\|27/05/2025
2372	Esomeprazole magnesium trihydrate, Micronised	SMILAX LABORATORIES LIMITED Hyderabad IN	100011578;100021649	CEP 2024-277 - Rev 00	2025/05/27	Valid	27/05/2030	Chemical	2025/05/27	New application\|CEP granted\|27/05/2025
1765	Salmeterol xinafoate	NEULAND LABORATORIES LIMITED Hyderabad IN	100011545;100062134	CEP 2011-277 - Rev 04	2025/05/26	Valid		Chemical	2025/08/11	Minor revision\|Accepted - CEP remains valid\|11/08/2025; Notification\|CEP granted\|26/05/2025; Minor revision\|CEP granted\|12/09/2023; Notification\|CEP granted\|07/09/2021
1368	Ramipril	NEULAND LABORATORIES LIMITED Hyderabad IN	100011545;100062134	CEP 2003-219 - Rev 08	2025/05/26	Valid		Chemical	2025/05/26	Notification\|CEP granted\|26/05/2025; Minor revision\|Accepted - CEP remains valid\|05/03/2024; Notification\|CEP granted\|16/12/2022; Minor revision\|Accepted - CEP remains valid\|14/11/2022
687	Salbutamol sulfate	NEULAND LABORATORIES LIMITED Hyderabad IN	100011545;100062134	CEP 2000-143 - Rev 08	2025/05/26	Valid		Chemical	2025/09/05	Minor revision\|Accepted - CEP remains valid\|05/09/2025; Notification\|CEP granted\|26/05/2025; Monograph revision\|Accepted - CEP remains valid\|26/03/2024; Major revision\|CEP granted\|15/03/2022
2258	Olanzapine, Form-1	NEULAND LABORATORIES LIMITED Hyderabad IN	100011545;100062134	CEP 2012-190 - Rev 02	2025/05/26	Valid		Chemical	2025/05/26	Notification\|CEP granted\|26/05/2025; Minor revision\|Accepted - CEP remains valid\|07/09/2022; Notification\|CEP granted\|07/09/2021
2535	Levetiracetam	NEULAND LABORATORIES LIMITED Hyderabad IN	100011545;100062134	CEP 2011-380 - Rev 08	2025/05/26	Valid		Chemical	2026/02/05	Minor revision\|Accepted - CEP remains valid\|05/02/2026; Minor revision\|Accepted - CEP remains valid\|21/08/2025; Notification\|CEP granted\|26/05/2025; Minor revision\|CEP granted\|02/08/2024; Administrative procedure\|CEP granted\|29/06/2023; Minor revision\|CEP granted\|15/06/2023; Minor revision\|CEP granted\|07/02/2022; Minor revision\|Accepted - CEP remains valid\|04/08/2021; Minor revision\|Accepted - CEP remains valid\|16/02/2021; Minor revision\|Accepted - CEP remains valid\|07/05/2020
2359	Dorzolamide hydrochloride	NEULAND LABORATORIES LIMITED Hyderabad IN	100011545;100062134	CEP 2008-155 - Rev 04	2025/05/26	Valid		Chemical	2025/11/19	Minor revision\|Accepted - CEP remains valid\|19/11/2025; Notification\|CEP granted\|26/05/2025; Minor revision\|Accepted - CEP remains valid\|25/10/2024; Minor revision\|Accepted - CEP remains valid\|24/01/2023; Notification\|CEP granted\|07/09/2021; Minor revision\|Accepted - CEP remains valid\|26/02/2021
2306	Gemcitabine hydrochloride, Process III	INTAS PHARMACEUTICALS LIMITED Ahmedabad IN	100011529;100023432	CEP 2022-092 - Rev 02	2025/05/26	Valid	13/07/2027	Chemical	2025/05/26	Minor revision\|CEP granted\|26/05/2025; Minor revision\|CEP granted\|02/09/2024; Minor revision\|Accepted - CEP remains valid\|07/11/2023; Notification\|Rejected\|08/09/2023; New application\|CEP granted\|13/07/2022
2733	Escitalopram oxalate, Process-III	NEULAND LABORATORIES LIMITED Hyderabad IN	100011545;100062134	CEP 2021-161 - Rev 03	2025/05/26	Valid	27/07/2026	Chemical	2025/05/26	Minor revision\|CEP granted\|26/05/2025; Minor revision\|CEP granted\|22/08/2024; Minor revision\|Accepted - CEP remains valid\|06/03/2024; Minor revision\|CEP granted\|07/08/2023; Minor revision\|Accepted - CEP remains valid\|02/02/2022; New application\|CEP granted\|27/07/2021
2932	Rivaroxaban, Micronised	MOEHS IBERICA S.L. Rubi ES	100029092;100068825	CEP 2021-245 - Rev 02	2025/05/26	Valid	27/06/2028	Chemical	2025/05/26	Minor revision\|CEP granted\|26/05/2025; Minor revision\|CEP granted\|07/09/2023; New application\|CEP granted\|27/06/2023
2604	Ropinirole hydrochloride, Form-I	NEULAND LABORATORIES LIMITED Hyderabad IN	100011545;100062134	CEP 2017-219 - Rev 04	2025/05/26	Valid		Chemical	2026/02/02	Minor revision\|Accepted - CEP remains valid\|02/02/2026; Minor revision\|Accepted - CEP remains valid\|23/09/2025; Notification\|CEP granted\|26/05/2025; Renewal\|CEP granted\|19/11/2024; Minor revision\|CEP granted\|17/01/2023; Minor revision\|CEP granted\|07/03/2022
2359	Dorzolamide hydrochloride, Process II	NEULAND LABORATORIES LIMITED Hyderabad IN	100011545;100062134	CEP 2017-089 - Rev 01	2025/05/26	Valid		Chemical	2025/05/26	Notification\|CEP granted\|26/05/2025; Minor revision\|Accepted - CEP remains valid\|24/02/2025; Minor revision\|Accepted - CEP remains valid\|06/08/2024; Renewal\|CEP granted\|22/08/2022; Notification\|CEP granted\|16/09/2021; Minor revision\|Accepted - CEP remains valid\|26/02/2021

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)	-