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
2932	Rivaroxaban, Micronised	SHENZHEN SALUBRIS PHARMACEUTICALS CO., LTD. Shenzhen City CN	100033629;100087648	CEP 2024-239 - Rev 00	2025/05/16	Valid	16/05/2030	Chemical	2025/05/16	New application\|CEP granted\|16/05/2025
1012	Famotidine	ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN	100006039;100002980	CEP 2015-216 - Rev 01	2025/05/16	Valid		Chemical	2025/05/16	Minor revision\|CEP granted\|16/05/2025; Minor revision\|Accepted - CEP remains valid\|02/12/2024; Minor revision\|Accepted - CEP remains valid\|31/03/2022; Renewal\|CEP granted\|18/01/2022; Minor revision\|CEP granted\|26/02/2021
2197	Brotizolam, Micronised	Boehringer Ingelheim Pharma GmbH & Co. KG Ingelheim Am Rhein DE	100000199;100004370	CEP 2008-063 - Rev 01	2025/05/16	Valid		Chemical	2025/05/16	Notification\|CEP granted\|16/05/2025
1422	Etodolac, Micronised	TARO PHARMACEUTICAL INDUSTRIES, LTD. Haifa Bay IL	100004559;100001120	CEP 2004-082 - Rev 07	2025/05/16	Valid		Chemical	2025/05/16	Major revision\|CEP granted\|16/05/2025; Minor revision\|CEP granted\|03/04/2023; Minor revision\|Accepted - CEP remains valid\|10/08/2022
1420	Enalapril maleate	ZHEJIANG CHANGMING PHARMACEUTICAL CO., LTD. Taizhou CN	100022703;100031392	CEP 2009-367 - Rev 03	2025/05/16	Valid		Chemical	2025/05/16	Administrative procedure\|CEP granted\|16/05/2025; Minor revision\|CEP granted\|28/04/2025; Minor revision\|Accepted - CEP remains valid\|03/10/2023; Minor revision\|Accepted - CEP remains valid\|18/07/2022; Minor revision\|Accepted - CEP remains valid\|09/04/2020
394	Hydrochlorothiazide, Form-I	AMOLI ORGANICS PRIVATE LIMITED Mumbai IN	100016500;100025303	CEP 2016-012 - Rev 02	2025/05/16	Valid		Chemical	2025/05/16	Notification\|CEP granted\|16/05/2025; Major revision\|CEP granted\|06/05/2024; Renewal\|CEP granted\|28/07/2022; Minor revision\|CEP granted\|12/01/2021; Minor revision\|CEP granted\|03/06/2020
3132	Mirabegron	AMI LIFESCIENCES PRIVATE LIMITED Vadodara IN	100021822;100030527	CEP 2024-105 - Rev 00	2025/05/16	Valid	16/05/2030	Chemical	2025/05/16	New application\|CEP granted\|16/05/2025
1339	Levocarnitine	CHENGDA PHARMACEUTICALS CO., LTD. Jiashan CN	100012006;100020624	CEP 2019-293 - Rev 02	2025/05/16	Valid		Chemical	2026/03/23	Renewal\|Accepted - CEP remains valid\|23/03/2026; Minor revision\|CEP granted\|16/05/2025; Monograph revision\|CEP granted\|24/03/2023
2813	Mycophenolate sodium, Source II	CONCORD BIOTECH LIMITED Ahmedabad IN	100005519;100000897	CEP 2019-278 - Rev 03	2025/05/16	Valid		Chemical	2025/05/16	Renewal\|CEP granted\|16/05/2025; Notification\|CEP granted\|15/03/2022; Monograph revision\|Accepted - CEP remains valid\|25/03/2021; Minor revision\|CEP granted\|09/12/2020
1311	Dinoprostone, Alternate Manufacturing Method	KYOWA PHARMA CHEMICAL CO., LTD. Takaoka JP	100012459;100023014	CEP 2025-081 - Rev 00	2025/05/16	Valid	16/05/2030	Chemical	2025/05/16	New application\|CEP granted\|16/05/2025
2735	Gadobutrol monohydrate	ST PHARM CO., LTD. Ansan-Si KR	100011895;100023373	CEP 2020-015 - Rev 02	2025/05/16	Valid	03/01/2027	Chemical	2025/05/16	Notification\|CEP granted\|16/05/2025; Minor revision\|Accepted - CEP remains valid\|14/01/2025; Minor revision\|Accepted - CEP remains valid\|24/08/2023; Notification\|Rejected\|26/06/2023; Minor revision\|CEP granted\|28/11/2022; Notification\|Accepted - CEP remains valid\|30/08/2022; New application\|CEP granted\|03/01/2022
1705	Sertraline hydrochloride, Form-II, Process-II	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2014-195 - Rev 03	2025/05/14	Valid		Chemical	2025/05/14	Minor revision\|CEP granted\|14/05/2025; Minor revision\|CEP granted\|20/09/2023; Minor revision\|CEP granted\|24/05/2022; Renewal\|CEP granted\|08/09/2020
803	Amiodarone hydrochloride	PIRAMAL PHARMA LIMITED Digwal Village IN	100036948;100058375	CEP 2009-291 - Rev 04	2025/05/14	Valid		Chemical	2025/05/14	Monograph revision\|CEP granted\|14/05/2025; Notification\|CEP granted\|07/01/2022; Notification\|CEP granted\|20/11/2020
859	Pyrazinamide	CALYX CHEMICALS AND PHARMACEUTICALS LIMITED Mumbai IN	100011607;100019628	CEP 2000-036 - Rev 06	2025/05/14	Valid		Chemical	2025/05/14	Minor revision\|CEP granted\|14/05/2025; Notification\|Accepted - CEP remains valid\|30/01/2020
942	Omeprazole, Form-B	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2015-011 - Rev 03	2025/05/14	Valid		Chemical	2025/05/14	Notification\|CEP granted\|14/05/2025; Notification\|Accepted - CEP remains valid\|15/04/2024; Administrative procedure\|CEP granted\|05/04/2024; Minor revision\|CEP granted\|08/11/2023; Renewal\|CEP granted\|08/09/2022
2736	Imatinib mesilate, FORM-β, ES Process	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2025-106 - Rev 00	2025/05/14	Valid	14/05/2030	Chemical	2025/05/14	New application\|CEP granted\|14/05/2025
1310	Dihydralazine sulfate, hydrated	AMOLI ORGANICS LLP Mumbai IN	100054134;100095785	CEP 2015-027 - Rev 01	2025/05/14	Valid		Chemical	2025/05/14	Notification\|CEP granted\|14/05/2025; Renewal\|CEP granted\|30/06/2021
1292	Amphotericin B, Process I	ZHEJIANG TIANTAI PHARMACEUTICAL CO., LTD. Taizhou City CN	100011852;100018559	CEP 2023-150 - Rev 01	2025/05/14	Valid	17/06/2029	Chemical	2025/05/14	Minor revision\|CEP granted\|14/05/2025; New application\|CEP granted\|17/06/2024
653	Baclofen	PIRAMAL PHARMA LIMITED Digwal Village IN	100036948;100058375	CEP 2016-313 - Rev 01	2025/05/14	Valid		Chemical	2025/05/14	Monograph revision\|CEP granted\|14/05/2025; Renewal\|CEP granted\|04/07/2023; Notification\|CEP granted\|07/01/2022; Notification\|CEP granted\|20/11/2020
2641	Dutasteride	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2014-306 - Rev 02	2025/05/13	Valid		Chemical	2025/05/13	Minor revision\|CEP granted\|13/05/2025; Notification\|CEP granted\|16/11/2023; Minor revision\|Accepted - CEP remains valid\|11/04/2022; Minor revision\|Accepted - CEP remains valid\|22/02/2021; Renewal\|CEP granted\|24/11/2020; Minor revision\|CEP granted\|28/04/2020

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)	-