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
1394	Bezafibrate	DEVI PHARMATECH PRIVATE LIMITED Visakhapatnam IN	100053267;100094028	CEP 2024-541 - Rev 00	2025/11/26	Valid	26/11/2030	Chemical	2025/11/26	New application\|CEP granted\|26/11/2025
1804	Hydroxypropylbetadex, Molar substitution (MS) 0.7	ZIBO QIANHUI BIOLOGICAL TECHNOLOGY CO., LTD. Zibo City CN	100046161;100076158	CEP 2024-542 - Rev 00	2025/11/26	Valid	26/11/2030	Chemical	2025/11/26	New application\|CEP granted\|26/11/2025
1486	Adenosine	PHARMA WALDHOF GMBH Duesseldorf DE	100035710;100056564	CEP 2025-070 - Rev 00	2025/11/26	Valid	26/11/2030	Chemical	2025/11/26	New application\|CEP granted\|26/11/2025
1386	Albendazole	SEQUENT SCIENTIFIC LIMITED Hyderabad IN	100017805;100096208	CEP 2005-010 - Rev 07	2025/11/24	Valid		Chemical	2025/11/24	Minor revision\|CEP granted\|24/11/2025; Minor revision\|CEP granted\|20/03/2025; Minor revision\|CEP granted\|20/12/2024; Notification\|Rejected\|25/11/2024; Minor revision\|CEP granted\|24/07/2024; Minor revision\|Accepted - CEP remains valid\|29/09/2021; Minor revision\|CEP granted\|21/12/2020
889	Clomipramine Hydrochloride	BIOPHORE INDIA PHARMACEUTICALS PRIVATE LIMITED Hyderabad IN	100028906;100063062	CEP 2017-288 - Rev 02	2025/11/24	Valid		Chemical	2025/11/24	Renewal\|CEP granted\|24/11/2025; Notification\|CEP granted\|15/05/2023
1681	Tramadol hydrochloride	VIRUPAKSHA ORGANICS LIMITED Hyderabad IN	100021606;100076961	CEP 2015-203 - Rev 03	2025/11/24	Valid		Chemical	2025/11/24	Minor revision\|CEP granted\|24/11/2025; Minor revision\|CEP granted\|25/07/2023; Minor revision\|CEP granted\|27/03/2023; Renewal\|CEP granted\|23/09/2021
2531	Clopidogrel hydrogen sulfate	AARTI DRUGS LIMITED Mumbai IN	100014953;100023652	CEP 2019-104 - Rev 02	2025/11/24	Valid		Chemical	2025/11/24	Renewal\|CEP granted\|24/11/2025; Minor revision\|CEP granted\|26/01/2023
2762	Capecitabine, Process II	INTAS PHARMACEUTICALS LIMITED Ahmedabad IN	100011529;100023432	CEP 2019-143 - Rev 02	2025/11/24	Valid		Chemical	2025/11/24	Renewal\|CEP granted\|24/11/2025; Transfer of holdership\|CEP granted\|27/06/2022
942	Omeprazole	NOSCH LABS PRIVATE LIMITED Hyderabad IN	100020550;100029297	CEP 2019-339 - Rev 01	2025/11/24	Valid		Chemical	2025/11/24	Renewal\|CEP granted\|24/11/2025
780	Oxytocin	PIRAMAL PHARMA LIMITED Navi Mumbai IN	100036948;100075608	CEP 2008-029 - Rev 05	2025/11/24	Valid		Chemical	2025/11/24	Major revision\|CEP granted\|24/11/2025; Minor revision\|Accepted - CEP remains valid\|16/06/2025; Minor revision\|Accepted - CEP remains valid\|07/03/2024; Notification\|Rejected\|02/01/2024; Monograph revision\|CEP granted\|03/11/2023; Notification\|CEP granted\|04/10/2022; Notification\|CEP granted\|26/07/2022; Minor revision\|CEP granted\|13/09/2021
1589	Doxylamine hydrogen succinate	HY-GRO CHEMICALS PHARMTEK PRIVATE LIMITED Secunderabad IN	100024077;100041595	CEP 2024-195 - Rev 00	2025/11/24	Valid	24/11/2030	Chemical	2025/11/24	New application\|CEP granted\|24/11/2025
2773	Memantine hydrochloride, Crystalline Form-I, Micronised and Non-micronised	MSN PHARMACHEM PRIVATE LIMITED Sangareddy District IN	100014794;100023345	CEP 2025-237 - Rev 00	2025/11/24	Valid	24/11/2030	Chemical	2025/11/24	New application\|CEP granted\|24/11/2025
3094	Erlotinib hydrochloride, Form-A	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2024-455 - Rev 00	2025/11/24	Valid	24/11/2030	Chemical	2025/11/24	New application\|CEP granted\|24/11/2025
3094	Erlotinib hydrochloride, Crystalline form-A, micronised and non-micronised	MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN	100011732;100023530	CEP 2025-362 - Rev 00	2025/11/24	Valid	24/11/2030	Chemical	2025/11/24	New application\|CEP granted\|24/11/2025
1783	Glycopyrronium bromide	SHANDONG RISEN-SUN PHARMACEUTICAL CO., LTD. Taian CN	100050469;100088103	CEP 2024-413 - Rev 00	2025/11/24	Valid	24/11/2030	Chemical	2025/11/24	New application\|CEP granted\|24/11/2025
1180	Buprenorphine, Process II	SPECGX LLC Webster Groves US	100017269;100031662	CEP 2025-111 - Rev 00	2025/11/24	Valid	24/11/2030	Chemical	2025/11/24	New application\|CEP granted\|24/11/2025
1210	Fentanyl	MACFARLAN SMITH LIMITED Edinburgh GB	100008070;100010773	CEP 2007-158 - Rev 02	2025/11/21	Valid		Chemical	2025/11/21	Minor revision\|CEP granted\|21/11/2025
2191	Atorvastatin calcium, Trihydrate Form-I, Micronised and Non-micronised	MSN PHARMACHEM PRIVATE LIMITED Sangareddy District IN	100014794;100023345	CEP 2011-068 - Rev 04	2025/11/21	Valid		Chemical	2025/11/21	Minor revision\|CEP granted\|21/11/2025; Minor revision\|CEP granted\|05/01/2024; Minor revision\|CEP granted\|10/02/2023; Monograph revision\|Accepted - CEP remains valid\|18/05/2022; Minor revision\|Accepted - CEP remains valid\|18/01/2021
888	Ciprofloxacin Hydrochloride	SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN	100008538;100018201	CEP 1998-090 - Rev 14	2025/11/21	Valid		Chemical	2025/11/21	Minor revision\|CEP granted\|21/11/2025; Minor revision\|CEP granted\|15/10/2024; Minor revision\|CEP granted\|29/08/2024; Minor revision\|CEP granted\|18/08/2022; Minor revision\|CEP granted\|17/02/2022; Minor revision\|CEP granted\|29/09/2020
136	Apomorphine hydrochloride hemihydrate	FRANCOPIA Paris FR	100041331;100098338	CEP 2008-332 - Rev 05	2025/11/21	Valid		Chemical	2025/11/21	Minor revision\|CEP granted\|21/11/2025; Notification\|CEP granted\|01/03/2024; Notification\|CEP granted\|02/05/2022

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)	-