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
910	Histidine Hydrochloride Monohydrate	SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN	100025187;100034386	CEP 2010-047 - Rev 02	2025/10/06	Valid		Chemical	2025/10/06	Notification\|CEP granted\|06/10/2025; Minor revision\|Accepted - CEP remains valid\|07/06/2024; Minor revision\|Accepted - CEP remains valid\|03/09/2021
752	Alanine	SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN	100025187;100034386	CEP 2007-351 - Rev 02	2025/10/06	Valid		Chemical	2025/10/06	Notification\|CEP granted\|06/10/2025; Notification\|Accepted - CEP remains valid\|06/05/2024; Minor revision\|Accepted - CEP remains valid\|11/08/2023; Major revision\|CEP granted\|12/01/2023; Major revision\|Rejected\|17/09/2021
803	Amiodarone hydrochloride	AREVIPHARMA GMBH Radebeul DE	100011616;100022155	CEP 2005-225 - Rev 04	2025/10/06	Valid		Chemical	2025/10/06	Administrative procedure\|CEP granted\|06/10/2025; Monograph revision\|Accepted - CEP remains valid\|22/09/2025; Minor revision\|CEP granted\|11/03/2024; Notification\|Accepted - CEP remains valid\|23/01/2020
1072	Betaxolol hydrochloride	FDC Limited Mumbai IN	100011646;100021030	CEP 2022-334 - Rev 01	2025/10/06	Valid	08/02/2029	Chemical	2025/10/06	Minor revision\|CEP granted\|06/10/2025; New application\|CEP granted\|08/02/2024
2372	Esomeprazole magnesium trihydrate, ESQ process	MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN	100051463;100098142	CEP 2023-164 - Rev 02	2025/10/06	Valid	23/06/2028	Chemical	2025/10/06	Notification\|CEP granted\|06/10/2025; Notification\|CEP granted\|29/07/2024; New application\|CEP granted\|23/06/2023
1734	Terbinafine hydrochloride, Process 2, Micronised, non-micronised	SHANDONG ANHONG PHARMACEUTICAL CO., LTD. Dezhou CN	100014777;100050265	CEP 2024-501 - Rev 01	2025/10/06	Valid	22/01/2030	Chemical	2025/10/06	Minor revision\|CEP granted\|06/10/2025; New application\|CEP granted\|22/01/2025
1292	Amphotericin B, Process II, for use in the manufacture of parenteral preparations	ZHEJIANG TIANTAI PHARMACEUTICAL CO., LTD. Taizhou City CN	100011852;100018559	CEP 2023-152 - Rev 01	2025/10/06	Valid	03/07/2029	Chemical	2025/10/06	Minor revision\|CEP granted\|06/10/2025; New application\|CEP granted\|03/07/2024
2192	Atovaquone	IPCA LABORATORIES LIMITED Mumbai IN	100011685;100018680	CEP 2021-107 - Rev 02	2025/10/06	Valid	21/01/2027	Chemical	2025/10/06	Administrative procedure\|CEP granted\|06/10/2025; Minor revision\|CEP granted\|24/09/2025; Notification\|Accepted - CEP remains valid\|23/06/2023; New application\|CEP granted\|21/01/2022
2579	Saw palmetto extract, DER : 10-14.3:1 - Extraction solvent : Ethanol 90% m/m	EUROMED S.A. Mollet del Vallès ES	100014852;100023498	CEP 2020-238 - Rev 02	2025/10/03	Valid		Herbal	2025/12/03	Notification\|Accepted - CEP remains valid\|03/12/2025; Renewal\|CEP granted\|03/10/2025; Monograph revision\|Accepted - CEP remains valid\|13/08/2024; Minor revision\|CEP granted\|21/01/2021; New application\|CEP granted\|05/11/2020
2338	Mirtazapine	MICRO LABS LIMITED Bengaluru IN	100017819;100077269	CEP 2025-182 - Rev 00	2025/10/03	Valid	03/10/2030	Chemical	2025/10/03	New application\|CEP granted\|03/10/2025
797	Aspartic Acid	WUHAN GRAND HOYO CO., LTD. Wuhan CN	100023371;100090500	CEP 2025-134 - Rev 00	2025/10/03	Valid	03/10/2030	Chemical	2025/10/03	New application\|CEP granted\|03/10/2025
2583	Montelukast sodium	MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN	100051463;100098142	CEP 2011-245 - Rev 04	2025/10/03	Valid		Chemical	2025/10/03	Administrative procedure\|CEP granted\|03/10/2025; Notification\|CEP granted\|15/09/2025; Monograph revision\|Accepted - CEP remains valid\|27/03/2025; Major revision\|CEP granted\|18/09/2024; Notification\|CEP granted\|01/09/2021
227	Lidocaine hydrochloride monohydrate	APEX HEALTHCARE LIMITED Ankleshwar IN	100039365;100061975	CEP 2024-258 - Rev 00	2025/10/02	Valid	02/10/2030	Chemical	2025/10/02	New application\|CEP granted\|02/10/2025
797	Aspartic Acid	SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN	100025187;100034386	CEP 2007-353 - Rev 02	2025/10/02	Valid		Chemical	2025/10/02	Notification\|CEP granted\|02/10/2025; Notification\|CEP granted\|15/05/2024; Minor revision\|Accepted - CEP remains valid\|09/05/2023
1335	Itraconazole, II	NOSCH LABS PRIVATE LIMITED Hyderabad IN	100020550;100029297	CEP 2025-246 - Rev 00	2025/10/02	Valid	02/10/2030	Chemical	2025/10/02	New application\|CEP granted\|02/10/2025
805	Arginine hydrochloride	SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN	100025187;100034386	CEP 2010-048 - Rev 01	2025/10/01	Valid		Chemical	2025/10/01	Notification\|CEP granted\|01/10/2025; Minor revision\|Accepted - CEP remains valid\|07/06/2024; Minor revision\|Accepted - CEP remains valid\|15/05/2023
911	Histidine	SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN	100025187;100034386	CEP 2010-046 - Rev 02	2025/10/01	Valid		Chemical	2025/10/01	Notification\|CEP granted\|01/10/2025; Minor revision\|Accepted - CEP remains valid\|07/06/2024; Notification\|Accepted - CEP remains valid\|09/02/2022; Minor revision\|Accepted - CEP remains valid\|16/12/2021
782	Phenylalanine	SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN	100025187;100034386	CEP 2010-225 - Rev 04	2025/10/01	Valid		Chemical	2025/10/01	Notification\|CEP granted\|01/10/2025; Minor revision\|CEP granted\|14/06/2024; Notification\|Accepted - CEP remains valid\|04/02/2022; Minor revision\|CEP granted\|29/11/2021
1756	Lamotrigine, Micronised and non-micronised	ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN	100011833;100018698	CEP 2010-208 - Rev 03	2025/10/01	Valid		Chemical	2025/10/01	Minor revision\|CEP granted\|01/10/2025; Major revision\|CEP granted\|02/12/2024; Major revision\|CEP granted\|02/02/2023; Notification\|Accepted - CEP remains valid\|18/02/2020
806	Arginine	SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN	100025187;100034386	CEP 2010-045 - Rev 01	2025/10/01	Valid		Chemical	2025/10/01	Notification\|CEP granted\|01/10/2025; Minor revision\|Accepted - CEP remains valid\|07/06/2024; Minor revision\|Accepted - CEP remains valid\|09/12/2022; Notification\|Accepted - CEP remains valid\|31/08/2020

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)	-