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
1616	Hydroxycarbamide	SHANDONG ANXIN PHARMACEUTICAL CO., LTD Jinan CN	100012114;100052387	CEP 2005-051 - Rev 05	2025/09/01	Valid		Chemical	2025/09/01	Notification\|CEP granted\|01/09/2025; Minor revision\|Accepted - CEP remains valid\|05/06/2023; Minor revision\|CEP granted\|24/09/2021; Minor revision\|Accepted - CEP remains valid\|24/02/2021
2598	Levofloxacin hemihydrate	ZHEJIANG MEDICINE CO., LTD. Shaoxing CN	100022357;100084942	CEP 2024-223 - Rev 00	2025/09/01	Valid	01/09/2030	Chemical	2025/09/01	New application\|CEP granted\|01/09/2025
2601	Pioglitazone hydrochloride, Crystalline form-I, micronised and non-micronised	MSN ORGANICS PRIVATE LIMITED Bibinagar Village IN	100012074;100018617	CEP 2013-005 - Rev 01	2025/09/01	Valid		Chemical	2025/09/01	Minor revision\|CEP granted\|01/09/2025; Minor revision\|Accepted - CEP remains valid\|05/05/2022
731	Naproxen	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2023-406 - Rev 00	2025/09/01	Valid	01/09/2030	Chemical	2025/09/01	New application\|CEP granted\|01/09/2025
1203	Estriol, Estriol LL	ASPEN OSS B.V. Oss NL	100011619;100050602	CEP 2020-208 - Rev 03	2025/08/29	Valid		Chemical	2025/08/29	Notification\|CEP granted\|29/08/2025; Renewal\|CEP granted\|11/07/2025; Notification\|Accepted - CEP remains valid\|27/07/2023; Notification\|CEP granted\|25/11/2022; New application\|CEP granted\|09/10/2020
2598	Levofloxacin hemihydrate	CHROMO LABORATORIES INDIA PRIVATE LIMITED Pashamylaram IN	100038839;100060978	CEP 2021-206 - Rev 01	2025/08/29	Valid	03/03/2030	Chemical	2025/08/29	Minor revision\|CEP granted\|29/08/2025; New application\|CEP granted\|03/03/2025
578	Ampicillin sodium, Sterile	FRESENIUS KABI IPSUM S.R.L. Cassina de’ Pecchi IT	100015105;100057989	CEP 2012-224 - Rev 06	2025/08/29	Valid		Chemical	2025/08/29	Major revision\|CEP granted\|29/08/2025; Monograph revision\|CEP granted\|21/02/2024; Administrative procedure\|CEP granted\|25/07/2022; Minor revision\|CEP granted\|06/05/2022; Minor revision\|CEP granted\|04/05/2021; Notification\|CEP granted\|11/02/2021
1028	Metoprolol tartrate	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2007-057 - Rev 05	2025/08/29	Valid		Chemical	2025/08/29	Notification\|CEP granted\|29/08/2025; Notification\|CEP granted\|03/01/2024; Minor revision\|CEP granted\|13/01/2023; Minor revision\|Accepted - CEP remains valid\|23/11/2020
2909	Tetracaine	CHIERON ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN	100053345;100094249	CEP 2020-209 - Rev 02	2025/08/29	Valid	27/10/2026	Chemical	2025/08/29	Administrative procedure\|CEP granted\|29/08/2025; Notification\|CEP granted\|17/06/2025; New application\|CEP granted\|27/10/2021
2284	Calcipotriol monohydrate	FORMOSA LABORATORIES, INC. Taoyuan TW	100011879;100018688	CEP 2010-187 - Rev 01	2025/08/29	Valid		Chemical	2025/08/29	Notification\|CEP granted\|29/08/2025; Minor revision\|Accepted - CEP remains valid\|07/03/2023; Notification\|Rejected\|03/02/2023; Notification\|Accepted - CEP remains valid\|22/07/2021
2535	Levetiracetam	GRANULES INDIA LIMITED Hyderabad IN	100011671;100097387	CEP 2023-138 - Rev 01	2025/08/29	Valid	05/07/2029	Chemical	2025/08/29	Notification\|CEP granted\|29/08/2025; New application\|CEP granted\|05/07/2024
1012	Famotidine, Dorog process	GEDEON RICHTER PLC. Budapest HU	100000640;100001653	CEP 2025-074 - Rev 00	2025/08/29	Valid	29/08/2030	Chemical	2025/08/29	New application\|CEP granted\|29/08/2025
1208	Fenbendazole for veterinary use	CHEMINO PHARMA LIMITED Mumbai IN	100049314;100083804	CEP 2023-363 - Rev 00	2025/08/29	Valid	29/08/2030	Chemical	2025/11/26	Minor revision\|Rejected\|26/11/2025; New application\|CEP granted\|29/08/2025
942	Omeprazole	GRANULES INDIA LIMITED Hyderabad IN	100011671;100097387	CEP 2022-406 - Rev 01	2025/08/29	Valid	10/06/2029	Chemical	2025/08/29	Notification\|CEP granted\|29/08/2025; New application\|CEP granted\|10/06/2024
2296	Pantoprazole sodium sesquihydrate, Form-I	GRANULES INDIA LIMITED Hyderabad IN	100011671;100097387	CEP 2022-383 - Rev 01	2025/08/29	Valid	07/08/2029	Chemical	2025/08/29	Notification\|CEP granted\|29/08/2025; New application\|CEP granted\|07/08/2024
2097	Mebeverine hydrochloride, Unit-II	COHANCE LIFESCIENCES LIMITED Mumbai IN	100011755;100090273	CEP 2022-476 - Rev 00	2025/08/29	Valid	29/08/2030	Chemical	2025/08/29	New application\|CEP granted\|29/08/2025
1563	Simvastatin	SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN	100023303;100032437	CEP 2005-300 - Rev 07	2025/08/28	Valid		Chemical	2025/08/28	Minor revision\|CEP granted\|28/08/2025; Minor revision\|Rejected\|23/04/2024; Notification\|CEP granted\|26/01/2024; Minor revision\|Accepted - CEP remains valid\|28/10/2022; Minor revision\|CEP granted\|18/06/2021
1058	Vancomycin hydrochloride, Precipitated process	ZHEJIANG MEDICINE CO., LTD. Xinchang CN	100022357;100062098	CEP 2010-198 - Rev 04	2025/08/28	Valid		Chemical	2025/08/28	Minor revision\|CEP granted\|28/08/2025; Monograph revision\|Accepted - CEP remains valid\|31/01/2025; Minor revision\|Accepted - CEP remains valid\|17/06/2022
1058	Vancomycin hydrochloride, Lyophilised Process	ZHEJIANG MEDICINE CO., LTD. Xinchang CN	100022357;100062098	CEP 2008-246 - Rev 04	2025/08/28	Valid		Chemical	2025/08/28	Minor revision\|CEP granted\|28/08/2025; Monograph revision\|Accepted - CEP remains valid\|31/01/2025; Minor revision\|Accepted - CEP remains valid\|17/06/2022
711	Cyclophosphamide monohydrate	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2014-342 - Rev 02	2025/08/28	Valid		Chemical	2025/08/28	Major revision\|CEP granted\|28/08/2025; Monograph revision\|CEP granted\|30/06/2023; Renewal\|CEP granted\|05/07/2021

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)	-