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
2593	Docetaxel, Process-IIb	INTAS PHARMACEUTICALS LIMITED Ahmedabad IN	100011529;100023432	CEP 2020-155 - Rev 02	2025/07/25	Valid		Chemical	2025/07/25	Renewal\|CEP granted\|25/07/2025; Minor revision\|CEP granted\|26/09/2024; New application\|CEP granted\|18/09/2020
319	Colistimethate sodium	LIANYUNGANG RUNZHONG PHARMACEUTICAL CO., LTD. Lianyungang CN	100019457;100028232	CEP 2015-189 - Rev 01	2025/07/25	Valid		Chemical	2025/07/25	Minor revision\|CEP granted\|25/07/2025; Minor revision\|Accepted - CEP remains valid\|20/08/2024; Major revision\|Accepted - CEP remains valid\|01/09/2023; Monograph revision\|Accepted - CEP remains valid\|16/05/2023; Renewal\|CEP granted\|10/12/2021
2258	Olanzapine, Micronised (Form-II), RX Code	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2025-203 - Rev 00	2025/07/25	Valid	25/07/2030	Chemical	2025/07/25	New application\|CEP granted\|25/07/2025
968	Aciclovir, Micronised and non-micronised	AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN	100046306;100076393	CEP 2020-013 - Rev 03	2025/07/25	Valid		Chemical	2025/09/29	Renewal\|Accepted - CEP remains valid\|29/09/2025; Minor revision\|CEP granted\|25/07/2025; Minor revision\|CEP granted\|26/03/2025; Minor revision\|CEP granted\|25/10/2022; New application\|CEP granted\|04/02/2021
2362	Rifaximin, Process-II	OPTIMUS DRUGS PRIVATE LIMITED Hyderabad IN	100020646;100092226	CEP 2025-071 - Rev 00	2025/07/25	Valid	25/07/2030	Chemical	2025/07/25	New application\|CEP granted\|25/07/2025
2778	Sitagliptin phosphate monohydrate, Process III	ZHEJIANG JINGSHENG PHARMACEUTICAL CO., LTD. Taizhou City CN	100048181;100079705	CEP 2025-109 - Rev 00	2025/07/25	Valid	25/07/2030	Chemical	2025/07/25	New application\|CEP granted\|25/07/2025
2359	Dorzolamide hydrochloride	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2009-093 - Rev 04	2025/07/25	Valid		Chemical	2025/07/25	Minor revision\|CEP granted\|25/07/2025; Notification\|CEP granted\|05/01/2022; Minor revision\|Accepted - CEP remains valid\|29/09/2021; Notification\|Accepted - CEP remains valid\|29/07/2020
2869	Fipronil for veterinary use	HUBEI MASTEAM BIO-TECH CO., LTD. Wuxue City CN	100044745;100073954	CEP 2023-280 - Rev 00	2025/07/25	Valid	25/07/2030	Chemical	2025/07/25	New application\|CEP granted\|25/07/2025
2751	Valaciclovir hydrochloride hydrate, Micronised and non-micronised	AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN	100046306;100076393	CEP 2020-059 - Rev 03	2025/07/25	Valid	19/02/2026	Chemical	2025/07/25	Minor revision\|CEP granted\|25/07/2025; Minor revision\|CEP granted\|25/03/2025; Minor revision\|CEP granted\|17/02/2022; New application\|CEP granted\|19/02/2021
1188	Cefixime, Process 2	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2011-243 - Rev 04	2025/07/25	Valid		Chemical	2025/07/25	Minor revision\|CEP granted\|25/07/2025; Notification\|Rejected\|02/06/2025; Notification\|CEP granted\|13/12/2023; Minor revision\|CEP granted\|14/09/2023; Major revision\|CEP granted\|18/01/2023; Minor revision\|Accepted - CEP remains valid\|01/09/2020
3132	Mirabegron	LEWENS LABS PRIVATE LIMITED Dahej IN	100042706;100070597	CEP 2024-344 - Rev 00	2025/07/25	Valid	25/07/2030	Chemical	2025/07/25	New application\|CEP granted\|25/07/2025
533	Triamcinolone acetonide	HENAN LIHUA PHARMACEUTICAL CO., LTD. Anyang CN	100016183;100024971	CEP 2024-217 - Rev 00	2025/07/25	Valid	25/07/2030	Chemical	2025/07/25	New application\|CEP granted\|25/07/2025
2422	Oseltamivir phosphate	BEIJING JINCHENG TAIER PHARMACEUTICAL CO., LTD. Beiwu Town CN	100049616;100085976	CEP 2023-418 - Rev 00	2025/07/25	Valid	25/07/2030	Chemical	2025/07/25	New application\|CEP granted\|25/07/2025
432	Rifamycin sodium	CKD BIO CORPORATION Ansan-si KR	100018976;100029257	CEP 2010-035 - Rev 02	2025/07/25	Valid		Chemical	2025/07/25	Minor revision\|CEP granted\|25/07/2025; Notification\|Rejected\|19/06/2025; Notification\|Accepted - CEP remains valid\|25/02/2021
2598	Levofloxacin hemihydrate	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2020-269 - Rev 02	2025/07/25	Valid	18/05/2027	Chemical	2025/07/25	Notification\|CEP granted\|25/07/2025; Administrative procedure\|CEP granted\|26/09/2024; Minor revision\|Accepted - CEP remains valid\|24/09/2024; Minor revision\|Accepted - CEP remains valid\|21/12/2023; New application\|CEP granted\|18/05/2022
353	Prednisolone, Process II	TIANJIN TIANYAO PHARMACEUTICALS CO., LTD. Tianjin CN	100011805;100018616	CEP 2020-217 - Rev 01	2025/07/24	Valid		Chemical	2025/12/01	Minor revision\|Accepted - CEP remains valid\|01/12/2025; Renewal\|CEP granted\|24/07/2025; New application\|CEP granted\|05/11/2020
662	Daunorubicin Hydrochloride	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2001-284 - Rev 04	2025/07/24	Valid		Chemical	2025/07/24	Notification\|CEP granted\|24/07/2025; Monograph revision\|Accepted - CEP remains valid\|17/02/2023; Minor revision\|CEP granted\|26/07/2022; Notification\|CEP granted\|20/12/2021; Notification\|Accepted - CEP remains valid\|26/06/2020
2305	Vigabatrin	SIONC PHARMACEUTICALS PVT. LTD. Visakhapatnam IN	100014842;100023477	CEP 2019-099 - Rev 01	2025/07/24	Valid	27/01/2027	Chemical	2025/07/24	Minor revision\|CEP granted\|24/07/2025
1756	Lamotrigine	ARAGEN LIFE SCIENCES LIMITED Hyderabad IN	100030840;100052317	CEP 2010-249 - Rev 07	2025/07/24	Valid		Chemical	2025/07/24	Minor revision\|CEP granted\|24/07/2025; Minor revision\|CEP granted\|27/11/2024; Notification\|CEP granted\|18/10/2023; Notification\|CEP granted\|24/05/2023; Minor revision\|CEP granted\|17/08/2022; Notification\|CEP granted\|22/02/2021
1103	Fentanyl citrate	SIEGFRIED GRAFTON INC. Grafton US	100042515;100070251	CEP 2005-081 - Rev 04	2025/07/22	Valid		Chemical	2025/07/22	Notification\|CEP granted\|22/07/2025; Notification\|CEP granted\|27/08/2021

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)	-