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
1444	Macrogols, Type 4000	NANJING WELL PHARMACEUTICAL GROUP CO., LTD. Nanjing CN	100051565;100090508	CEP 2025-274 - Rev 00	2026/02/06	Valid	06/02/2031	Chemical	2026/02/06	New application\|CEP granted\|06/02/2026
2771	Ibandronate sodium monohydrate	MAPRIMED S.A. Buenos Aires AR	100012039;100018552	CEP 2025-243 - Rev 00	2026/02/06	Valid	06/02/2031	Chemical	2026/02/06	New application\|CEP granted\|06/02/2026
.	Purified bovine Haemoglobin, Compound 800 (C-800)	BIOS BIOTECHNOLOGY COMPANY LTD. Hong Kong Island HK	100054542;100096660	CEP 2020-428 - Rev 01	2026/02/05	Valid	26/10/2026	TSE	2026/02/05	Transfer of holdership\|CEP granted\|05/02/2026; Major revision\|Accepted - CEP remains valid\|07/08/2025; New application\|CEP granted\|26/10/2021
1246	Nitrendipine	EGIS Pharmaceuticals PLC Budapest X HU	100001091;100001662	CEP 2019-209 - Rev 02	2026/02/05	Valid		Chemical	2026/02/05	Monograph revision\|CEP granted\|05/02/2026; Renewal\|CEP granted\|18/06/2025; Notification\|Accepted - CEP remains valid\|29/07/2022; Minor revision\|Accepted - CEP remains valid\|20/11/2020
758	Colchicine	CHEMICAL RESOURCES Panchkula IN	100048957;100082031	CEP 2023-446 - Rev 00	2026/02/05	Valid	05/02/2031	Chemical	2026/02/06	New application\|CEP granted\|06/02/2026
2600	Olmesartan medoxomil, Micronised	YANTAI VALIANT PHARMACEUTICAL CO. LTD. Yantai CN	100044353;100073319	CEP 2024-350 - Rev 01	2026/02/05	Valid	26/01/2031	Chemical	2026/02/05	Administrative procedure\|CEP granted\|05/02/2026; New application\|CEP granted\|26/01/2026
1569	Sufentanil	SPECGX LLC Webster Groves US	100017269;100031662	CEP 2019-054 - Rev 01	2026/02/05	Valid		Chemical	2026/02/05	Renewal\|CEP granted\|05/02/2026; Minor revision\|Accepted - CEP remains valid\|08/04/2024
2866	Gefitinib	SAKAR HEALTHCARE LIMITED Ahmedabad IN	100033943;100085048	CEP 2024-578 - Rev 00	2026/02/05	Valid	05/02/2031	Chemical	2026/02/05	New application\|CEP granted\|05/02/2026
2857	Trazodone hydrochloride	MAHI DRUGS PRIVATE LIMITED Hyderabad IN	100048039;100079525	CEP 2024-399 - Rev 00	2026/02/05	Valid	05/02/2031	Chemical	2026/02/05	New application\|CEP granted\|05/02/2026
1654	Lymecycline	VIRDEV INTERMEDIATES PVT. LTD. Surat IN	100049143;100082993	CEP 2024-386 - Rev 00	2026/02/05	Valid	05/02/2031	Chemical	2026/02/05	New application\|CEP granted\|05/02/2026
2631	Rosuvastatin calcium, Process III	NINGBO MENOVO PHARMACEUTICAL CO., LTD. Ningbo CN	100030313;100047776	CEP 2025-486 - Rev 00	2026/02/05	Valid	05/02/2031	Chemical	2026/02/05	New application\|CEP granted\|05/02/2026
1491	Amlodipine besilate, Process II	NOVARTIS PHARMA AG Basel CH	100003908;100000364	CEP 2008-122 - Rev 03	2026/02/04	Valid		Chemical	2026/02/04	Monograph revision\|CEP granted\|04/02/2026; Notification\|CEP granted\|14/12/2023; Minor revision\|Accepted - CEP remains valid\|29/08/2022
388	Dexamethasone, Crystalline Form-B	XI’AN GUOKANG RUIJIN PHARMACEUTICAL CO., LTD. Xi’an CN	100039231;100096104	CEP 2023-244 - Rev 00	2026/02/04	Valid	04/02/2031	Chemical	2026/02/04	New application\|CEP granted\|04/02/2026
2577	Oxcarbazepine, Micronised and non-micronised	HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO., LTD. Ezhou CN	100015482;100024200	CEP 2018-165 - Rev 05	2026/02/04	Valid		Chemical	2026/02/04	Minor revision\|CEP granted\|04/02/2026; Administrative procedure\|CEP granted\|02/12/2024; Minor revision\|CEP granted\|21/11/2024; Renewal\|CEP granted\|03/10/2024; Minor revision\|CEP granted\|07/07/2023
942	Omeprazole, Micronised and sieved grade	ESTEVE QUIMICA S.A. Barcelona ES	100002266;100056508	CEP 1998-145 - Rev 12	2026/02/04	Valid		Chemical	2026/02/04	Notification\|CEP granted\|04/02/2026; Minor revision\|CEP granted\|12/07/2024; Notification\|Accepted - CEP remains valid\|20/04/2023; Transfer of holdership\|CEP granted\|16/03/2022; Notification\|Accepted - CEP remains valid\|04/11/2021; Notification\|CEP granted\|24/03/2020
2932	Rivaroxaban	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2023-231 - Rev 02	2026/02/04	Valid	19/11/2029	Chemical	2026/02/04	Administrative procedure\|CEP granted\|04/02/2026; Minor revision\|CEP granted\|26/01/2026; Notification\|Rejected\|17/12/2025; Minor revision\|Accepted - CEP remains valid\|10/07/2025; New application\|CEP granted\|19/11/2024
859	Pyrazinamide	ANUH PHARMA LIMITED Mumbai IN	100021566;100030259	CEP 2005-059 - Rev 04	2026/02/04	Valid		Chemical	2026/02/04	Notification\|CEP granted\|04/02/2026; Minor revision\|CEP granted\|30/04/2020
401	Levothyroxine sodium hydrate	MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN	100011732;100023530	CEP 2025-250 - Rev 00	2026/02/04	Valid	04/02/2031	Chemical	2026/02/04	New application\|CEP granted\|04/02/2026
2756	Amorolfine hydrochloride	ZHEJIANG CDMO PHARMACEUTICAL CO., LTD Jinhua CN	100051857;100091157	CEP 2024-449 - Rev 00	2026/02/04	Valid	04/02/2031	Chemical	2026/02/04	New application\|CEP granted\|04/02/2026
2931	Sorafenib tosilate	KINHOO PHARMACEUTICAL CO., LTD. Zhuhai CN	100050160;100087573	CEP 2024-398 - Rev 00	2026/02/04	Valid	04/02/2031	Chemical	2026/02/04	New application\|CEP granted\|04/02/2026

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)	-