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
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
2778	Sitagliptin phosphate monohydrate	OPTIMUS DRUGS PRIVATE LIMITED Hyderabad IN	100020646;100092226	CEP 2023-273 - Rev 00	2025/05/23	Valid	23/05/2030	Chemical	2025/05/23	New application\|CEP granted\|23/05/2025
599	Cisplatin, CISPLATIN SF	UMICORE ARGENTINA S.A. Pilar AR	100022008;100030708	CEP 2024-550 - Rev 00	2025/05/23	Valid	23/05/2030	Chemical	2025/05/23	New application\|CEP granted\|23/05/2025
1075	Budesonide, Process 2B, micronised	FERMION OY Espoo FI	100011508;100020280	CEP 2025-102 - Rev 00	2025/05/23	Valid	23/05/2030	Chemical	2026/03/18	Notification\|Accepted - CEP remains valid\|18/03/2026; New application\|CEP granted\|23/05/2025
2777	Pregabalin	AALIDHRA PHARMACHEM PRIVATE LIMITED Nandesari IN	100042480;100070177	CEP 2019-085 - Rev 03	2025/05/21	Valid		Chemical	2025/05/21	Renewal\|CEP granted\|21/05/2025; Minor revision\|CEP granted\|07/03/2023; Minor revision\|CEP granted\|08/03/2022
1075	Budesonide	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 1997-067 - Rev 10	2025/05/21	Valid		Chemical	2025/05/21	Minor revision\|CEP granted\|21/05/2025; Notification\|Accepted - CEP remains valid\|03/04/2023; Notification\|CEP granted\|20/12/2021; Notification\|Accepted - CEP remains valid\|27/11/2020
2866	Gefitinib, Micronised	CIPLA LIMITED Mumbai IN	100006004;100018147	CEP 2017-002 - Rev 01	2025/05/21	Valid		Chemical	2025/05/21	Minor revision\|CEP granted\|21/05/2025; Renewal\|CEP granted\|24/03/2023
334	Hydrocortisone acetate, Micronised	FARMABIOS S.p.A Gropello Cairoli IT	100011643;100021232	CEP 2018-171 - Rev 01	2025/05/21	Valid		Chemical	2025/05/21	Renewal\|CEP granted\|21/05/2025; Major revision\|Rejected\|20/08/2024; Major revision\|Rejected\|20/08/2024
1648	Thioctic acid	SUZHOU MEDINOAH LTD. Suzhou CN	100048896;100081951	CEP 2023-451 - Rev 00	2025/05/21	Valid	21/05/2030	Chemical	2025/05/21	New application\|CEP granted\|21/05/2025
758	Colchicine	ALCHEM INTERNATIONAL PRIVATE LIMITED Faridabad IN	100011947;100018683	CEP 2019-146 - Rev 02	2025/05/21	Valid		Chemical	2025/05/21	Renewal\|CEP granted\|21/05/2025; Monograph revision\|Accepted - CEP remains valid\|04/11/2024; Minor revision\|CEP granted\|16/02/2024
2931	Sorafenib tosilate	CHONGQING CARELIFE PHARMACEUTICAL CO., LTD. Chongqing CN	100011995;100018631	CEP 2023-373 - Rev 00	2025/05/21	Valid	21/05/2030	Chemical	2025/05/21	New application\|CEP granted\|21/05/2025
2733	Escitalopram oxalate	MICRO LABS LIMITED Bengaluru IN	100017819;100077269	CEP 2016-250 - Rev 02	2025/05/20	Valid		Chemical	2025/05/20	Administrative procedure\|CEP granted\|20/05/2025; Minor revision\|CEP granted\|13/05/2025; Renewal\|CEP granted\|16/01/2023; Minor revision\|CEP granted\|29/04/2022; Minor revision\|Accepted - CEP remains valid\|09/06/2021; Minor revision\|CEP granted\|16/09/2020; Minor revision\|Accepted - CEP remains valid\|05/06/2020

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)	-