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
2372	Esomeprazole magnesium trihydrate, Powder	JUBILANT BIOSYS LIMITED Nanjangud IN	100055198;100098088	CEP 2023-175 - Rev 02	2025/10/17	Valid	18/08/2028	Chemical	2025/10/17	Notification\|CEP granted\|17/10/2025; Administrative procedure\|CEP granted\|23/08/2023; New application\|CEP granted\|18/08/2023
2766	Exemestane, Micronised	SYNTHON B.V. Nijmegen NL	100001342;100005475	CEP 2022-424 - Rev 02	2025/10/17	Valid	06/10/2028	Chemical	2025/10/17	Notification\|CEP granted\|17/10/2025; Minor revision\|CEP granted\|02/09/2024; New application\|CEP granted\|06/10/2023
1563	Simvastatin, Ethanol II process	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2019-179 - Rev 02	2025/10/17	Valid		Chemical	2025/10/17	Renewal\|CEP granted\|17/10/2025; Notification\|CEP granted\|20/12/2021
577	Amoxicillin sodium, Sterile, Enzymatic route	SANDOZ GMBH Kundl AT	100000546;100000450	CEP 2025-064 - Rev 01	2025/10/17	Valid	28/03/2030	Chemical	2025/10/17	Notification\|CEP granted\|17/10/2025; New application\|CEP granted\|28/03/2025
543	Carbamazepine, Carbamazepine CBA Powder	JUBILANT BIOSYS LIMITED Nanjangud IN	100055198;100098088	CEP 2024-439 - Rev 01	2025/10/17	Valid	05/03/2030	Chemical	2025/10/17	Notification\|CEP granted\|17/10/2025; New application\|CEP granted\|05/03/2025
2733	Escitalopram oxalate	JUBILANT BIOSYS LIMITED Nanjangud IN	100055198;100098088	CEP 2017-082 - Rev 01	2025/10/17	Valid		Chemical	2025/10/17	Notification\|CEP granted\|17/10/2025; Renewal\|CEP granted\|09/06/2023; Notification\|CEP granted\|12/08/2022
1363	Prilocaine Hydrochloride	MOEHS IBERICA S.L. Rubi ES	100029092;100068825	CEP 2025-153 - Rev 00	2025/10/17	Valid	17/10/2030	Chemical	2025/10/17	New application\|CEP granted\|17/10/2025
2631	Rosuvastatin calcium, Process-II	AMOLI ORGANICS PRIVATE LIMITED Mumbai IN	100016500;100025303	CEP 2025-379 - Rev 00	2025/10/16	Valid	16/10/2030	Chemical	2025/10/16	New application\|CEP granted\|16/10/2025
3049	Etonogestrel	CURIA SPAIN S.A.U. Boecillo ES	100011649;100019586	CEP 2025-093 - Rev 01	2025/10/16	Valid	19/09/2030	Chemical	2025/10/16	Notification\|CEP granted\|16/10/2025; New application\|CEP granted\|19/09/2025
1564	Sodium alendronate trihydrate	IPCA LABORATORIES LIMITED Mumbai IN	100011685;100018680	CEP 2008-090 - Rev 03	2025/10/16	Valid		Chemical	2025/10/16	Minor revision\|CEP granted\|16/10/2025; Notification\|Accepted - CEP remains valid\|23/06/2023; Minor revision\|CEP granted\|27/04/2021
525	Propylthiouracil	NANTONG JINGHUA PHARMACEUTICAL CO., LTD. Nantong CN	100018246;100052237	CEP 2023-467 - Rev 01	2025/10/16	Valid	01/04/2030	Chemical	2025/10/16	Monograph revision\|CEP granted\|16/10/2025; New application\|CEP granted\|01/04/2025
312	Betamethasone	MSD EUROPE BELGIUM Watermael-Boitsfort BE	100049238;100083482	CEP 2017-092 - Rev 02	2025/10/16	Valid		Chemical	2025/10/16	Administrative procedure\|CEP granted\|16/10/2025; Minor revision\|CEP granted\|25/09/2025; Renewal\|CEP granted\|12/12/2022
1765	Salmeterol xinafoate	INDUSTRIALE CHIMICA S.R.L. Saronno IT	100011692;100020331	CEP 2013-107 - Rev 02	2025/10/16	Valid		Chemical	2025/10/16	Notification\|CEP granted\|16/10/2025; Notification\|Rejected\|02/10/2025; Notification\|CEP granted\|18/03/2022
968	Aciclovir, Site Khazipally	AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN	100046306;100076393	CEP 2021-274 - Rev 01	2025/10/16	Valid	07/10/2026	Chemical	2025/10/16	Minor revision\|CEP granted\|16/10/2025; New application\|CEP granted\|07/10/2021
729	Naloxone hydrochloride dihydrate, Process II	NORAMCO, LLC. Wilmington US	100048651;100080628	CEP 2025-340 - Rev 00	2025/10/15	Valid	15/10/2030	Chemical	2025/10/15	New application\|CEP granted\|15/10/2025
2779	Solifenacin succinate, Process 2	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2024-429 - Rev 02	2025/10/15	Valid	12/12/2029	Chemical	2025/10/15	Notification\|CEP granted\|15/10/2025; Notification\|CEP granted\|12/03/2025; New application\|CEP granted\|12/12/2024
1322	Fenofibrate	OLON S.P.A. Rodano IT	100012085;100019537	CEP 2003-260 - Rev 06	2025/10/15	Valid		Chemical	2025/10/15	Minor revision\|CEP granted\|15/10/2025; Minor revision\|CEP granted\|29/03/2022; Minor revision\|CEP granted\|10/02/2021
1792	Nicotine resinate, Nicotine content 15% with glycerol 22.0-26.0%	FERTIN PHARMA A/S Vejle DK	100000411;100003193	CEP 2012-226 - Rev 01	2025/10/15	Valid		Chemical	2025/10/15	Notification\|CEP granted\|15/10/2025; Notification\|Accepted - CEP remains valid\|09/07/2025; Notification\|Accepted - CEP remains valid\|04/08/2023
2089	Acarbose	CKD BIO CORPORATION Ansan-si KR	100018976;100029257	CEP 2007-252 - Rev 03	2025/10/14	Valid		Chemical	2025/10/14	Minor revision\|CEP granted\|14/10/2025; Notification\|Accepted - CEP remains valid\|06/11/2023; Notification\|Accepted - CEP remains valid\|30/01/2023; Notification\|Accepted - CEP remains valid\|04/04/2022; Notification\|Accepted - CEP remains valid\|29/09/2020
1662	Tyrothricin	XELLIA PHARMACEUTICALS LTD. Budapest X HU	100012234;100020635	CEP 2013-205 - Rev 03	2025/10/14	Valid		Chemical	2025/10/14	Major revision\|CEP granted\|14/10/2025; Minor revision\|Accepted - CEP remains valid\|12/02/2024; Notification\|Accepted - CEP remains valid\|05/01/2023; Major revision\|CEP granted\|20/12/2021; Administrative procedure\|CEP granted\|12/03/2021; Notification\|Accepted - CEP remains valid\|01/03/2021

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)	-