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
3137	Dapagliflozin propylene glycol monohydrate	METROCHEM API PRIVATE LIMITED Hyderabad IN	100045158;100074519	CEP 2025-043 - Rev 00	2025/08/06	Valid	06/08/2030	Chemical	2025/08/06	New application\|CEP granted\|06/08/2025
2135	Repaglinide, Form I	USV PRIVATE LIMITED Mumbai IN	100006251;100010851	CEP 2009-239 - Rev 03	2025/08/05	Valid		Chemical	2025/08/05	Minor revision\|CEP granted\|05/08/2025; Minor revision\|Accepted - CEP remains valid\|24/01/2022
203	Polymyxin B sulfate	LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN	100020920;100029633	CEP 2023-251 - Rev 01	2025/08/05	Valid	19/03/2029	Chemical	2025/08/05	Minor revision\|CEP granted\|05/08/2025; New application\|CEP granted\|19/03/2024
2258	Olanzapine	MACLEODS PHARMACEUTICALS LIMITED Mumbai IN	100021441;100077265	CEP 2018-111 - Rev 01	2025/08/05	Valid		Chemical	2025/08/05	Renewal\|CEP granted\|05/08/2025
1114	Iohexol	DIVI'S LABORATORIES LIMITED Hyderabad IN	100011666;100052116	CEP 2022-240 - Rev 01	2025/08/05	Valid	19/04/2029	Chemical	2026/04/28	Notification\|Accepted - CEP remains valid\|28/04/2026; Minor revision\|CEP granted\|05/08/2025; Minor revision\|Accepted - CEP remains valid\|26/09/2024; New application\|CEP granted\|19/04/2024
74	Codeine phosphate hemihydrate, Codeine Phosphate Hemihydrate Process-II	SUN PHARMACEUTICAL INDUSTRIES (AUSTRALIA) PTY LIMITED Port Fairy AU	100023901;100054445	CEP 2020-385 - Rev 01	2025/08/05	Valid	10/08/2026	Chemical	2025/08/05	Minor revision\|CEP granted\|05/08/2025; New application\|CEP granted\|10/08/2021
2814	Thiocolchicoside hydrate	QUAD LIFESCIENCES PRIVATE LIMITED S.A.S Nagar IN	100050170;100087590	CEP 2024-043 - Rev 00	2025/08/05	Valid	05/08/2030	Chemical	2025/08/05	New application\|CEP granted\|05/08/2025
1648	Thioctic acid	AMI LIFESCIENCES PRIVATE LIMITED Vadodara IN	100021822;100030527	CEP 2023-352 - Rev 00	2025/08/05	Valid	05/08/2030	Chemical	2025/08/05	New application\|CEP granted\|05/08/2025
334	Hydrocortisone acetate, Micronised, alternative process	FARMABIOS S.p.A Gropello Cairoli IT	100011643;100021232	CEP 2024-068 - Rev 01	2025/08/05	Valid	31/07/2029	Chemical	2025/08/05	Minor revision\|CEP granted\|05/08/2025; New application\|CEP granted\|31/07/2024
3095	Dabigatran etexilate mesilate	Changzhou Pharmaceutical Factory Changzhou CN	100012704;100018611	CEP 2023-435 - Rev 00	2025/08/05	Valid	05/08/2030	Chemical	2025/08/05	New application\|CEP granted\|05/08/2025
2179	Pimobendan for Veterinary Use	SCI PHARMTECH, INC. Taoyuan City TW	100017752;100052419	CEP 2024-121 - Rev 00	2025/08/05	Valid	05/08/2030	Chemical	2025/08/05	New application\|CEP granted\|05/08/2025
543	Carbamazepine	BAJAJ HEALTHCARE LIMITED Thane IN	100021782;100061986	CEP 2021-339 - Rev 01	2025/08/01	Valid	17/02/2030	Chemical	2025/08/01	Minor revision\|CEP granted\|01/08/2025; New application\|CEP granted\|17/02/2025
1764	Rocuronium bromide, Process II	ZHEJIANG XIANJU PHARMACEUTICAL CO., LTD. Taizhou CN	100022759;100031459	CEP 2025-319 - Rev 00	2025/08/01	Valid	01/08/2030	Chemical	2025/08/01	New application\|CEP granted\|01/08/2025
2849	Hydroxychloroquine sulfate	LAURUS LABS LIMITED Hyderabad IN	100011702;100032608	CEP 2020-129 - Rev 03	2025/08/01	Valid		Chemical	2025/08/01	Renewal\|CEP granted\|01/08/2025; Notification\|CEP granted\|25/01/2023; Minor revision\|CEP granted\|22/04/2021; New application\|CEP granted\|28/10/2020
2288	Citalopram hydrobromide, CTP Process	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2012-120 - Rev 05	2025/08/01	Valid		Chemical	2025/08/01	Minor revision\|CEP granted\|01/08/2025; Minor revision\|CEP granted\|11/09/2024; Minor revision\|CEP granted\|17/11/2021
2760	Brimonidine tartrate	SIEGFRIED GRAFTON, INC. Grafton US	100042515;100070251	CEP 2015-265 - Rev 01	2025/08/01	Valid		Chemical	2025/08/01	Notification\|CEP granted\|01/08/2025; Notification\|Accepted - CEP remains valid\|02/05/2024; Notification\|Accepted - CEP remains valid\|04/05/2023; Renewal\|CEP granted\|24/01/2023; Notification\|CEP granted\|27/08/2021
2675	Irinotecan hydrochloride trihydrate	LAURUS LABS LIMITED Hyderabad IN	100011702;100032608	CEP 2019-292 - Rev 03	2025/08/01	Valid	19/10/2026	Chemical	2025/08/01	Minor revision\|CEP granted\|01/08/2025; Minor revision\|Rejected\|23/05/2025; Minor revision\|Accepted - CEP remains valid\|25/11/2024; Minor revision\|CEP granted\|11/12/2023; Minor revision\|CEP granted\|26/01/2023
2258	Olanzapine	SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN	100032307;100078783	CEP 2012-050 - Rev 04	2025/07/31	Valid		Chemical	2025/07/31	Notification\|CEP granted\|31/07/2025; Major revision\|CEP granted\|14/05/2025; Minor revision\|CEP granted\|21/02/2023
1295	Calcifediol monohydrate	FORMOSA LABORATORIES, INC. Taoyuan TW	100011879;100018688	CEP 2019-163 - Rev 03	2025/07/31	Valid	28/10/2026	Chemical	2025/07/31	Minor revision\|CEP granted\|31/07/2025; Minor revision\|CEP granted\|27/08/2024; Notification\|Rejected\|08/07/2024; Administrative procedure\|CEP granted\|16/11/2021
2593	Docetaxel	FUJIAN SOUTH PHARMACEUTICAL CO., LTD. Sanming CN	100012371;100021536	CEP 2016-204 - Rev 05	2025/07/31	Valid		Chemical	2025/07/31	Minor revision\|CEP granted\|31/07/2025; Renewal\|CEP granted\|20/12/2023; Minor revision\|CEP granted\|03/10/2022; Minor revision\|CEP granted\|16/03/2021

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)	-