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
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
14	Calcium carbonate, Sieved grade I (35)	OMYA SAS Omey FR	100020502;100081592	CEP 2001-366 - Rev 05	2025/11/21	Valid		Chemical	2025/11/21	Minor revision\|CEP granted\|21/11/2025; Minor revision\|CEP granted\|25/05/2021; Minor revision\|CEP granted\|08/12/2020
619	Levomenthol	FREY + LAU GMBH Henstedt-Ulzburg DE	100017333;100026131	CEP 2019-058 - Rev 01	2025/11/21	Valid		Chemical	2025/11/21	Renewal\|CEP granted\|21/11/2025; Renewal\|Abandoned\|04/07/2025; Notification\|Accepted - CEP remains valid\|13/08/2021; Notification\|Accepted - CEP remains valid\|25/02/2021
2930	Valganciclovir hydrochloride	SHANGHAI PHARMA GROUP CHANGZHOU KONY PHARMACEUTICAL CO., LTD. Luoyang Town CN	100020594;100034407	CEP 2024-326 - Rev 00	2025/11/21	Valid	21/11/2030	Chemical	2025/11/21	New application\|CEP granted\|21/11/2025
260	Amoxicillin trihydrate, Sterile	NORTH CHINA PHARMACEUTICAL GROUP SEMISYNTECH CO. LTD. Shijiazhuang CN	100023274;100032418	CEP 2024-583 - Rev 00	2025/11/21	Valid	21/11/2030	Chemical	2025/11/21	New application\|CEP granted\|21/11/2025
2017	Oxaliplatin	SHANDONG BOYUAN PHARMACEUTICAL CO., LTD. Jinan City CN	100037406;100076812	CEP 2013-113 - Rev 01	2025/11/21	Valid		Chemical	2026/01/19	Minor revision\|Accepted - CEP remains valid\|19/01/2026; Minor revision\|CEP granted\|21/11/2025
1794	Paclitaxel	WUXI TAXUS PHARMACEUTICAL CO. LTD. Wuxi City CN	100052831;100093126	CEP 2024-437 - Rev 00	2025/11/21	Valid	21/11/2030	Chemical	2025/11/21	New application\|CEP granted\|21/11/2025
1702	Naproxen sodium	HETERO LABS LIMITED Hyderabad IN	100011681;100018664	CEP 2022-389 - Rev 01	2025/11/19	Valid	13/09/2029	Chemical	2025/11/19	Minor revision\|CEP granted\|19/11/2025; New application\|CEP granted\|16/09/2024
2756	Amorolfine hydrochloride, Nantong site	SIEGFRIED AG Zofingen CH	100011797;100022117	CEP 2017-251 - Rev 01	2025/11/19	Valid		Chemical	2025/11/19	Minor revision\|CEP granted\|19/11/2025; Minor revision\|Accepted - CEP remains valid\|22/08/2024; Renewal\|CEP granted\|11/01/2023
781	Phenoxyethanol	ICN POLFA RZESZOW S.A. Rzeszow PL	100000280;100004301	CEP 2023-276 - Rev 01	2025/11/19	Valid	06/05/2029	Chemical	2025/11/19	Minor revision\|CEP granted\|19/11/2025; New application\|CEP granted\|06/05/2024
67	Folic acid hydrate	ZHEJIANG SHENGDA BIO-PHARM CO., LTD. Tiantai CN	100024864;100041389	CEP 2023-161 - Rev 01	2025/11/19	Valid	13/11/2029	Chemical	2025/11/19	Notification\|CEP granted\|19/11/2025; New application\|CEP granted\|13/11/2024
2341	Cefpodoxime proxetil, Process 3	QILU ANTIBIOTICS PHARMACEUTICAL CO. LTD. Jinan CN	100033695;100052910	CEP 2020-399 - Rev 02	2025/11/19	Valid		Chemical	2025/11/19	Renewal\|CEP granted\|19/11/2025; Minor revision\|CEP granted\|03/01/2025; Notification\|Accepted - CEP remains valid\|17/11/2022; Minor revision\|Accepted - CEP remains valid\|18/01/2022; New application\|CEP granted\|15/03/2021
3087	Ticagrelor, Standard, micronised	ZAKŁADY FARMACEUTYCZNE POLPHARMA S.A. Starogard Gdański PL	100000470;100001572	CEP 2020-338 - Rev 04	2025/11/19	Valid	15/05/2028	Chemical	2025/11/19	Notification\|CEP granted\|19/11/2025; Minor revision\|CEP granted\|27/10/2025; Minor revision\|CEP granted\|23/08/2024; Minor revision\|CEP granted\|17/01/2024; New application\|CEP granted\|15/05/2023

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)	-