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
2232	Losartan potassium, New process	NINGBO MENOVO PHARMACEUTICAL CO., LTD. Ningbo CN	100030313;100047776	CEP 2021-344 - Rev 02	2025/12/09	Valid	04/03/2027	Chemical	2025/12/09	Major revision\|CEP granted\|09/12/2025; Minor revision\|CEP granted\|20/05/2025; Minor revision\|Accepted - CEP remains valid\|03/06/2024; New application\|CEP granted\|04/03/2022
2338	Mirtazapine, Route code "ZA"	MAITHRI DRUGS PRIVATE LIMITED Bonthapally Village IN	100020971;100029680	CEP 2018-225 - Rev 02	2025/12/09	Valid		Chemical	2025/12/09	Minor revision\|CEP granted\|09/12/2025; Renewal\|CEP granted\|10/04/2024
2420	Tiotropium bromide monohydrate, Micronised and non-micronised	BREATHGREEN PHARMACEUTICAL CO. LTD. Zaozhuang City CN	100048781;100081153	CEP 2025-254 - Rev 00	2025/12/09	Valid	09/12/2030	Chemical	2025/12/09	New application\|CEP granted\|09/12/2025
414	Sodium thiosulfate	QUALITY CHEMICALS S.L. Esparreguera ES	100025665;100034895	CEP 2024-569 - Rev 00	2025/12/09	Valid	09/12/2030	Chemical	2025/12/09	New application\|CEP granted\|09/12/2025
1191	Clozapine	MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN	100051463;100098142	CEP 2008-234 - Rev 03	2025/12/08	Valid		Chemical	2025/12/08	Minor revision\|CEP granted\|08/12/2025; Notification\|CEP granted\|26/07/2024; Minor revision\|Accepted - CEP remains valid\|06/10/2022; Minor revision\|Accepted - CEP remains valid\|06/05/2022; Minor revision\|Accepted - CEP remains valid\|27/05/2021; Minor revision\|Accepted - CEP remains valid\|15/09/2020; Minor revision\|Accepted - CEP remains valid\|24/04/2020
1491	Amlodipine besilate, Process-I	ARENE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN	100033956;100079880	CEP 2020-371 - Rev 05	2025/12/08	Valid		Chemical	2026/03/17	Renewal\|Accepted - CEP remains valid\|17/03/2026; Monograph revision\|CEP granted\|08/12/2025; Minor revision\|CEP granted\|18/03/2025; Minor revision\|CEP granted\|18/07/2023; Major revision\|CEP granted\|11/04/2022; Minor revision\|Rejected\|17/11/2021; Administrative procedure\|CEP granted\|08/04/2021; New application\|CEP granted\|26/03/2021
244	Prochlorperazine Maleate	BIOPHORE INDIA PHARMACEUTICALS PRIVATE LIMITED Hyderabad IN	100028906;100063062	CEP 2019-071 - Rev 02	2025/12/08	Valid		Chemical	2025/12/08	Renewal\|CEP granted\|08/12/2025; Notification\|CEP granted\|15/05/2023
2287	Fluconazole	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2007-071 - Rev 06	2025/12/08	Valid		Chemical	2025/12/08	Monograph revision\|CEP granted\|08/12/2025; Minor revision\|Accepted - CEP remains valid\|06/06/2024; Notification\|CEP granted\|21/11/2023; Minor revision\|CEP granted\|18/08/2023; Monograph revision\|Accepted - CEP remains valid\|02/05/2023; Minor revision\|Accepted - CEP remains valid\|24/02/2022; Minor revision\|CEP granted\|24/06/2020
1425	Fosfomycin trometamol	INTERQUIM S.A. DE C.V. Estado De Mexico MX	100019787;100036773	CEP 2017-166 - Rev 04	2025/12/08	Valid		Chemical	2025/12/08	Notification\|CEP granted\|08/12/2025; Renewal\|CEP granted\|02/08/2024; Notification\|CEP granted\|12/10/2022; Minor revision\|CEP granted\|18/08/2021
2296	Pantoprazole sodium sesquihydrate, Process-II	MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN	100051463;100098142	CEP 2025-353 - Rev 00	2025/12/08	Valid	08/12/2030	Chemical	2025/12/08	New application\|CEP granted\|08/12/2025
1094	Cyproterone acetate, Micronised and non-micronised	HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO., LTD. Huanggang CN	100015482;100089636	CEP 2025-414 - Rev 00	2025/12/08	Valid	08/12/2030	Chemical	2025/12/08	New application\|CEP granted\|08/12/2025
2287	Fluconazole, Process III	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2025-415 - Rev 00	2025/12/08	Valid	08/12/2030	Chemical	2025/12/08	New application\|CEP granted\|08/12/2025
2296	Pantoprazole sodium sesquihydrate, Process III	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	100049668;100086364	CEP 2024-346 - Rev 00	2025/12/04	Valid	04/12/2030	Chemical	2025/12/04	New application\|CEP granted\|04/12/2025
2775	Nebivolol hydrochloride	ALKEM LABORATORIES LIMITED Mumbai IN	100005554;100010367	CEP 2024-481 - Rev 00	2025/12/04	Valid	04/12/2030	Chemical	2025/12/04	New application\|CEP granted\|04/12/2025
3052	Lercanidipine hydrochloride, Amorphous	MAITHRI DRUGS PRIVATE LIMITED Bonthapally Village IN	100020971;100029680	CEP 2024-409 - Rev 00	2025/12/04	Valid	04/12/2030	Chemical	2025/12/04	New application\|CEP granted\|04/12/2025
1491	Amlodipine besilate, Site-II	HETERO DRUGS LIMITED Hyderabad IN	100008415;100014434	CEP 2025-407 - Rev 00	2025/12/04	Valid	04/12/2030	Chemical	2025/12/04	New application\|CEP granted\|04/12/2025
937	Minoxidil	IOL CHEMICALS AND PHARMACEUTICALS LIMITED Ludhiana IN	100017919;100037377	CEP 2024-558 - Rev 00	2025/12/04	Valid	04/12/2030	Chemical	2025/12/04	New application\|CEP granted\|04/12/2025
2583	Montelukast sodium	SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN	100044578;100073706	CEP 2024-125 - Rev 00	2025/12/03	Valid	03/12/2030	Chemical	2025/12/03	New application\|CEP granted\|03/12/2025
391	Furosemide, Alternative process	SRI KRISHNA PHARMACEUTICALS LIMITED Hyderabad IN	100015104;100023787	CEP 2013-273 - Rev 01	2025/12/03	Valid		Chemical	2025/12/03	Minor revision\|CEP granted\|03/12/2025; Minor revision\|Accepted - CEP remains valid\|20/09/2022; Minor revision\|Accepted - CEP remains valid\|21/03/2022
3095	Dabigatran etexilate mesilate	HIKAL LIMITED Bangalore IN	100014769;100023445	CEP 2024-363 - Rev 00	2025/12/03	Valid	03/12/2030	Chemical	2025/12/03	New application\|CEP granted\|03/12/2025

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)	-