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
687	Salbutamol sulfate	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2020-100 - Rev 03	2025/07/04	Valid	14/09/2026	Chemical	2025/07/04	Notification\|CEP granted\|04/07/2025; Notification\|CEP granted\|24/10/2024; Monograph revision\|Accepted - CEP remains valid\|01/02/2024; Notification\|CEP granted\|20/12/2021; New application\|CEP granted\|14/09/2021
2766	Exemestane	CORAL DRUGS PRIVATE LIMITED New Delhi IN	100019182;100042823	CEP 2023-032 - Rev 00	2025/07/04	Valid	04/07/2030	Chemical	2025/07/04	New application\|CEP granted\|04/07/2025
1648	Thioctic acid, Type II	OLON S.P.A. Rodano IT	100012085;100019537	CEP 2025-138 - Rev 00	2025/07/04	Valid	04/07/2030	Chemical	2025/07/04	New application\|CEP granted\|04/07/2025
3095	Dabigatran etexilate mesilate, Micronised and non-micronised	ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN	100011833;100018698	CEP 2023-458 - Rev 00	2025/07/04	Valid	04/07/2030	Chemical	2025/07/04	New application\|CEP granted\|04/07/2025
1275	Ursodeoxycholic acid	CHANGDE YUNGANG BIOTECHNOLOGY CO. LTD. Changde CN	100048318;100079973	CEP 2023-296 - Rev 00	2025/07/04	Valid	04/07/2030	Chemical	2025/07/04	New application\|CEP granted\|04/07/2025
3036	Teriflunomide	MAPRIMED S.A. Buenos Aires AR	100012039;100018552	CEP 2022-005 - Rev 01	2025/07/04	Valid	05/05/2028	Chemical	2025/07/04	Minor revision\|CEP granted\|04/07/2025; Minor revision\|Accepted - CEP remains valid\|17/11/2023; New application\|CEP granted\|05/05/2023
2306	Gemcitabine hydrochloride	SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN	100044578;100073706	CEP 2006-222 - Rev 02	2025/07/03	Valid		Chemical	2025/07/03	Minor revision\|CEP granted\|03/07/2025; Minor revision\|CEP granted\|23/02/2023
2585	Rizatriptan benzoate	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2011-201 - Rev 04	2025/07/03	Valid		Chemical	2025/07/03	Minor revision\|CEP granted\|03/07/2025; Minor revision\|CEP granted\|07/05/2024; Notification\|CEP granted\|05/01/2024; Minor revision\|Accepted - CEP remains valid\|17/06/2022; Monograph revision\|CEP granted\|23/02/2021
2531	Clopidogrel hydrogen sulfate, Form I	ZYDUS LIFESCIENCES LIMITED Vadodara IN	100005979;100074301	CEP 2011-152 - Rev 05	2025/07/03	Valid		Chemical	2025/07/03	Minor revision\|CEP granted\|03/07/2025; Minor revision\|CEP granted\|20/12/2024; Major revision\|CEP granted\|28/04/2023; Notification\|CEP granted\|07/07/2022; Minor revision\|Accepted - CEP remains valid\|29/06/2020
1611	Diosmin	SICHUAN XIELI PHARMACEUTICAL CO., LTD. Pengzhou CN	100017947;100052361	CEP 2013-229 - Rev 02	2025/07/03	Valid		Chemical	2025/07/03	Minor revision\|CEP granted\|03/07/2025; Minor revision\|CEP granted\|03/06/2025; Minor revision\|Accepted - CEP remains valid\|14/02/2023; Minor revision\|Accepted - CEP remains valid\|19/01/2021; Notification\|Rejected\|20/10/2020; Minor revision\|Accepted - CEP remains valid\|24/08/2020
654	Beclometasone dipropionate, Micronised, non micronised	TAPI NL B.V. Amsterdam NL	100003852;100094134	CEP 2003-254 - Rev 07	2025/07/03	Valid		Chemical	2025/07/03	Notification\|CEP granted\|03/07/2025; Notification\|CEP granted\|17/08/2023; Notification\|CEP granted\|04/01/2022; Minor revision\|CEP granted\|22/01/2021
2780	Temozolomide	SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN	100044578;100073706	CEP 2016-277 - Rev 01	2025/07/03	Valid		Chemical	2025/07/03	Minor revision\|CEP granted\|03/07/2025; Renewal\|CEP granted\|12/07/2022; Monograph revision\|Accepted - CEP remains valid\|24/09/2020
1524	Gliclazide	SOHAN HEALTHCARE PVT. LTD. Pune IN	100024454;100033626	CEP 2020-237 - Rev 01	2025/07/03	Valid	02/05/2028	Chemical	2025/07/03	Major revision\|CEP granted\|03/07/2025; New application\|CEP granted\|02/05/2023
2631	Rosuvastatin calcium	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2016-097 - Rev 02	2025/07/03	Valid		Chemical	2025/07/03	Notification\|CEP granted\|03/07/2025; Notification\|CEP granted\|08/02/2023; Renewal\|CEP granted\|02/09/2022; Major revision\|CEP granted\|28/01/2021; Minor revision\|Rejected\|05/10/2020; Monograph revision\|CEP granted\|25/06/2020
2404	Drospirenone, Process 2	INDUSTRIALE CHIMICA S.R.L. Saronno IT	100011692;100020331	CEP 2022-506 - Rev 01	2025/07/03	Valid	10/01/2030	Chemical	2025/07/03	Minor revision\|CEP granted\|03/07/2025; New application\|CEP granted\|10/01/2025
3011	all-rac-Phytomenadione	BIOPHORE INDIA PHARMACEUTICALS PRIVATE LIMITED Hyderabad IN	100028906;100063062	CEP 2017-243 - Rev 02	2025/07/03	Valid		Chemical	2025/07/03	Renewal\|CEP granted\|03/07/2025; Monograph revision\|CEP granted\|22/03/2022
2577	Oxcarbazepine, Micronised and non-micronised	MSN LIFE SCIENCES PRIVATE LIMITED Medak IN	100018316;100027671	CEP 2024-309 - Rev 00	2025/07/03	Valid	03/07/2030	Chemical	2025/07/03	New application\|CEP granted\|03/07/2025
3014	Rotigotine	SHODHANA LABORATORIES PRIVATE LIMITED Hyderabad IN	100021550;100030244	CEP 2024-265 - Rev 00	2025/07/03	Valid	03/07/2030	Chemical	2025/07/03	New application\|CEP granted\|03/07/2025
1425	Fosfomycin trometamol	NANJING DORRA PHARMACEUTICAL TECHNOLOGY CO. LTD. Nanjing CN	100041071;100087393	CEP 2024-168 - Rev 00	2025/07/03	Valid	03/07/2030	Chemical	2025/07/03	New application\|CEP granted\|03/07/2025
2229	Enrofloxacin for veterinary use	SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN	100023303;100032437	CEP 2023-156 - Rev 01	2025/07/03	Valid	21/06/2029	Chemical	2025/07/03	Minor revision\|CEP granted\|03/07/2025; New application\|CEP granted\|21/06/2024

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)	-