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
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
388	Dexamethasone, Micronised	SYMBIOTEC PHARMALAB PRIVATE LIMITED Indore IN	100018972;100095999	CEP 2023-083 - Rev 00	2025/05/26	Valid	26/05/2030	Chemical	2025/05/26	New application\|CEP granted\|26/05/2025
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	2025/05/23	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
2268	Selamectin for veterinary use	ZHEJIANG JINHUA CONBA BIO-PHARM. CO., LTD. Jinhua City CN	100024897;100034088	CEP 2018-272 - Rev 03	2025/05/23	Valid		Chemical	2025/05/23	Renewal\|CEP granted\|23/05/2025; Major revision\|CEP granted\|12/04/2023; Minor revision\|CEP granted\|13/01/2021
2535	Levetiracetam	DR. REDDY'S LABORATORIES LIMITED Hyderabad IN	100003991;100000217	CEP 2011-084 - Rev 02	2025/05/23	Valid		Chemical	2025/05/23	Major revision\|CEP granted\|23/05/2025; Minor revision\|Accepted - CEP remains valid\|18/04/2023; Minor revision\|Accepted - CEP remains valid\|15/02/2023; Minor revision\|Accepted - CEP remains valid\|03/05/2022; Minor revision\|Accepted - CEP remains valid\|31/05/2021
2280	Fexofenadine hydrochloride	MOREPEN LABORATORIES LIMITED Baddi IN	100017843;100026642	CEP 2015-256 - Rev 01	2025/05/23	Valid		Chemical	2025/05/23	Minor revision\|CEP granted\|23/05/2025; Minor revision\|Accepted - CEP remains valid\|10/02/2023; Renewal\|CEP granted\|16/09/2021
1724	Formoterol fumarate dihydrate, Non-micronised (code 7544AO), micronised (code 7544MO)	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2008-042 - Rev 05	2025/05/23	Valid		Chemical	2025/05/23	Notification\|CEP granted\|23/05/2025; Minor revision\|Accepted - CEP remains valid\|10/06/2024; Minor revision\|Accepted - CEP remains valid\|24/01/2023; Monograph revision\|Accepted - CEP remains valid\|21/07/2022; Notification\|CEP granted\|04/01/2022; Administrative procedure\|CEP granted\|30/09/2020; Minor revision\|CEP granted\|15/09/2020
1059	Zidovudine	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2008-333 - Rev 07	2025/05/23	Valid		Chemical	2025/05/23	Notification\|CEP granted\|23/05/2025; Notification\|CEP granted\|10/04/2024; Notification\|CEP granted\|07/12/2022; Minor revision\|CEP granted\|28/07/2022; Monograph revision\|Accepted - CEP remains valid\|15/07/2021
2372	Esomeprazole magnesium trihydrate	SRINI PHARMACEUTICALS PRIVATE LIMITED Choutuppal IN	100018880;100027661	CEP 2019-113 - Rev 01	2025/05/23	Valid		Chemical	2025/05/23	Renewal\|CEP granted\|23/05/2025
603	Disulfiram	SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN	100032307;100078783	CEP 2019-197 - Rev 02	2025/05/23	Valid	05/07/2026	Chemical	2025/05/23	Minor revision\|CEP granted\|23/05/2025; Major revision\|CEP granted\|15/07/2024; Minor revision\|Abandoned\|18/03/2024
2338	Mirtazapine, Anhydrous	Zhejiang Liaoyuan Pharmaceutical Co., Ltd. Duqiao Town CN	100012649;100020326	CEP 2020-158 - Rev 02	2025/05/23	Valid		Chemical	2025/05/23	Renewal\|CEP granted\|23/05/2025; Minor revision\|CEP granted\|08/02/2023; New application\|CEP granted\|15/09/2020
2813	Mycophenolate sodium	WUXI FORTUNE PHARMACEUTICAL CO., LTD. Wuxi CN	100022282;100030975	CEP 2022-433 - Rev 01	2025/05/23	Valid	16/07/2029	Chemical	2025/05/23	Minor revision\|CEP granted\|23/05/2025; New application\|CEP granted\|16/07/2024
330	Gelatin, Limed hide gelatin	GELITA AG Eberbach DE	100012955;100080863	CEP 2019-340 - Rev 01	2025/05/23	Valid		TSE	2025/05/23	Renewal\|CEP granted\|23/05/2025
721	Ibuprofen	LUNA CHEMICAL INDUSTRIES PRIVATE LIMITED Bharuch IN	100050540;100088252	CEP 2022-112 - Rev 00	2025/05/23	Valid	23/05/2030	Chemical	2025/05/23	New application\|CEP granted\|23/05/2025
1616	Hydroxycarbamide	BO-CHEM PRIVATE LIMITED Mumbai IN	100050126;100087586	CEP 2024-209 - Rev 00	2025/05/23	Valid	23/05/2030	Chemical	2025/05/23	New application\|CEP granted\|23/05/2025

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)	-