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
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
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	2026/02/19	Minor revision\|Accepted - CEP remains valid\|19/02/2026; 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
2598	Levofloxacin hemihydrate	NEULAND LABORATORIES LIMITED Hyderabad IN	100011545;100062134	CEP 2019-023 - Rev 06	2025/05/26	Valid		Chemical	2025/12/19	Minor revision\|Accepted - CEP remains valid\|19/12/2025; Notification\|CEP granted\|26/05/2025; Renewal\|CEP granted\|10/03/2025; Minor revision\|CEP granted\|07/11/2023; Minor revision\|Accepted - CEP remains valid\|09/06/2023; Minor revision\|CEP granted\|10/02/2023; Notification\|CEP granted\|08/09/2021; Major revision\|CEP granted\|16/02/2021
1420	Enalapril maleate, Process II	NEULAND LABORATORIES LIMITED Hyderabad IN	100011545;100062134	CEP 2024-245 - Rev 01	2025/05/26	Valid	13/11/2029	Chemical	2025/12/09	Minor revision\|Accepted - CEP remains valid\|09/12/2025; Notification\|CEP granted\|26/05/2025; New application\|CEP granted\|13/11/2024
1764	Rocuronium bromide	SHANGHAI JUNMED HEALTHCARE CO., LTD Shanghai CN	100049770;100086790	CEP 2023-169 - Rev 00	2025/05/26	Valid	26/05/2030	Chemical	2025/05/26	New application\|CEP granted\|26/05/2025
2258	Olanzapine, Form II, micronised	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2024-297 - Rev 01	2025/05/26	Valid	23/12/2029	Chemical	2025/05/26	Notification\|CEP granted\|26/05/2025; New application\|CEP granted\|23/12/2024
2733	Escitalopram oxalate	NEULAND LABORATORIES LIMITED Hyderabad IN	100011545;100062134	CEP 2017-217 - Rev 02	2025/05/23	Valid		Chemical	2026/02/19	Minor revision\|Accepted - CEP remains valid\|19/02/2026; Minor revision\|CEP granted\|23/05/2025; Minor revision\|CEP granted\|23/08/2024; Renewal\|CEP granted\|06/07/2023; Notification\|CEP granted\|08/09/2021
1201	Doxapram hydrochloride monohydrate	MIDAS PHARMA GMBH Ingelheim am Rhein DE	100001328;100004656	CEP 2017-084 - Rev 01	2025/05/23	Valid		Chemical	2025/08/01	Notification\|Accepted - CEP remains valid\|01/08/2025; Monograph revision\|CEP granted\|23/05/2025; Renewal\|CEP granted\|17/07/2023; Minor revision\|CEP granted\|13/08/2021
2992	Lacosamide, Form-I	ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN	100006039;100002980	CEP 2018-276 - Rev 02	2025/05/23	Valid		Chemical	2025/05/23	Renewal\|CEP granted\|23/05/2025; Minor revision\|Accepted - CEP remains valid\|24/10/2024; Minor revision\|Accepted - CEP remains valid\|02/11/2023; Minor revision\|Accepted - CEP remains valid\|19/01/2023; Minor revision\|Accepted - CEP remains valid\|22/09/2022; Notification\|Accepted - CEP remains valid\|02/05/2022; Minor revision\|CEP granted\|25/09/2020

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)	-