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
2126	Cefepime dihydrochloride monohydrate, Sterile	ACS DOBFAR S.P.A. Tribiano IT	100011589;100019524	CEP 2023-021 - Rev 01	2025/11/19	Valid	27/07/2028	Chemical	2025/11/19	Major revision\|CEP granted\|19/11/2025; New application\|CEP granted\|27/07/2023
1131	Methylprednisolone hydrogen succinate	HENAN LIHUA PHARMACEUTICAL CO., LTD. Anyang CN	100016183;100024971	CEP 2024-159 - Rev 00	2025/11/17	Valid	17/11/2030	Chemical	2025/11/17	New application\|CEP granted\|17/11/2025
3095	Dabigatran etexilate mesilate	AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN	100046306;100076393	CEP 2023-382 - Rev 00	2025/11/17	Valid	17/11/2030	Chemical	2025/11/17	New application\|CEP granted\|17/11/2025
559	Mannitol, For use in the manufacture of parenteral preparations	CARGILL S.R.L. Castelmassa IT	100049176;100083235	CEP 2005-019 - Rev 04	2025/11/17	Valid		Chemical	2025/11/17	Minor revision\|CEP granted\|17/11/2025; Notification\|CEP granted\|24/06/2025
2932	Rivaroxaban	Changzhou Pharmaceutical Factory Changzhou CN	100012704;100018611	CEP 2021-252 - Rev 01	2025/11/17	Valid	12/09/2027	Chemical	2025/11/17	Minor revision\|CEP granted\|17/11/2025; Notification\|Accepted - CEP remains valid\|20/12/2023; New application\|CEP granted\|12/09/2022
687	Salbutamol sulfate, Micronised	VAMSI LABS LIMITED Solapur IN	100014747;100096958	CEP 2024-328 - Rev 00	2025/11/17	Valid	17/11/2030	Chemical	2025/11/17	New application\|CEP granted\|17/11/2025
524	Promethazine hydrochloride	EMCURE PHARMACEUTICALS LIMITED Pune IN	100011677;100022690	CEP 2024-304 - Rev 00	2025/11/17	Valid	17/11/2030	Chemical	2025/11/17	New application\|CEP granted\|17/11/2025
1336	Ivermectin, Code iverm11	ZHEJIANG HISUN PHARMACEUTICAL CO., LTD. Taizhou City CN	100011825;100018687	CEP 2025-175 - Rev 01	2025/11/17	Valid	22/08/2030	Chemical	2025/11/17	Minor revision\|CEP granted\|17/11/2025; New application\|CEP granted\|22/08/2025
2541	Quetiapine Fumarate, Form-I	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2015-153 - Rev 04	2025/11/17	Valid		Chemical	2025/11/17	Notification\|CEP granted\|17/11/2025; Minor revision\|Accepted - CEP remains valid\|22/08/2025; Minor revision\|CEP granted\|05/12/2024; Minor revision\|Accepted - CEP remains valid\|28/11/2023; Minor revision\|CEP granted\|15/06/2023; Minor revision\|CEP granted\|26/10/2022; Renewal\|CEP granted\|05/04/2022; Major revision\|CEP granted\|04/11/2021; Minor revision\|Rejected\|22/02/2021
1670	Glutathione	SHANDONG JINCHENG BIO-PHARMACEUTICAL CO. LTD. Zibo CN	100039047;100061447	CEP 2024-255 - Rev 00	2025/11/17	Valid	17/11/2030	Chemical	2025/11/17	New application\|CEP granted\|17/11/2025
1012	Famotidine, FM3 Process	IPCA LABORATORIES LIMITED Mumbai IN	100011685;100018680	CEP 2022-213 - Rev 02	2025/11/14	Valid	18/01/2028	Chemical	2025/11/14	Minor revision\|CEP granted\|14/11/2025; Minor revision\|CEP granted\|20/10/2023; New application\|CEP granted\|18/01/2023
2191	Atorvastatin calcium, Form-I	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2018-049 - Rev 04	2025/11/14	Valid		Chemical	2026/01/26	Notification\|Accepted - CEP remains valid\|26/01/2026; Minor revision\|CEP granted\|14/11/2025; Renewal\|CEP granted\|19/05/2025; Minor revision\|Accepted - CEP remains valid\|19/08/2024; Major revision\|CEP granted\|26/04/2024; Monograph revision\|CEP granted\|24/03/2023; Major revision\|Rejected\|28/03/2022
1653	Potassium clavulanate, diluted, Microcrystalline cellulose 1:1 blend	SMITHKLINE BEECHAM LIMITED Irvine GB	100000119;100003201	CEP 2005-244 - Rev 02	2025/11/14	Valid		Chemical	2025/11/14	Minor revision\|CEP granted\|14/11/2025; Minor revision\|Accepted - CEP remains valid\|30/09/2020
2787	Esomeprazole magnesium dihydrate	LEE PHARMA LIMITED Hyderabad IN	100014849;100042625	CEP 2021-334 - Rev 01	2025/11/14	Valid	03/05/2027	Chemical	2025/11/14	Minor revision\|CEP granted\|14/11/2025; New application\|CEP granted\|03/05/2022
388	Dexamethasone	TIANJIN TIANYAO PHARMACEUTICALS CO., LTD. Tianjin CN	100011805;100018616	CEP 2015-205 - Rev 01	2025/11/14	Valid		Chemical	2025/11/14	Minor revision\|CEP granted\|14/11/2025; Renewal\|CEP granted\|16/08/2021
1484	Levocabastine hydrochloride, Process Part 2	KATSURA CHEMICAL CO., LTD. Zama JP	100025070;100034253	CEP 2018-217 - Rev 02	2025/11/14	Valid		Chemical	2025/11/14	Minor revision\|CEP granted\|14/11/2025; Renewal\|CEP granted\|02/09/2024; Minor revision\|Accepted - CEP remains valid\|02/09/2022
1408	Cilastatin sodium, Sterile	SHANDONG ANHONG PHARMACEUTICAL CO., LTD. Dezhou CN	100014777;100050265	CEP 2025-103 - Rev 00	2025/11/14	Valid	14/11/2030	Chemical	2025/11/14	New application\|CEP granted\|14/11/2025
576	Allopurinol, Site-II	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2025-441 - Rev 00	2025/11/14	Valid	14/11/2030	Chemical	2025/11/14	New application\|CEP granted\|14/11/2025
3132	Mirabegron	MEGAFINE PHARMA PRIVATE LIMITED Mumbai IN	100011550;100021133	CEP 2024-087 - Rev 02	2025/11/14	Valid	28/03/2030	Chemical	2025/11/14	Administrative procedure\|CEP granted\|14/11/2025; Major revision\|CEP granted\|03/11/2025; New application\|CEP granted\|28/03/2025
1688	Articaine hydrochloride	SHANDONG CHENGHUI SHUANGDA PHARMACEUTICAL CO., LTD. Dezhou City CN	100048410;100080174	CEP 2023-255 - Rev 01	2025/11/13	Valid	03/01/2030	Chemical	2025/11/13	Minor revision\|CEP granted\|13/11/2025; New application\|CEP granted\|03/01/2025

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)	-