欧洲药典适用性证书数据库
(Certificates of Suitability to the monographs of European Pharmacopoeia, EDQM)
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 证书结束日期 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
2931 Sorafenib tosilate TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL 100000702;100060842 CEP 2021-247 - Rev 01 2024/04/23 Valid 10/07/2028 Chemical 2024/04/23 Minor revision|CEP granted|23/04/2024;
New application|CEP granted|10/07/2023
1790 Naltrexone hydrochloride, Wavelength site NORAMCO, LLC. Wilmington US 100048651;100080628 CEP 2020-291 - Rev 02 2024/04/23 Valid 24/11/2025 Chemical 2024/04/23 Notification|CEP granted|23/04/2024;
Notification|CEP granted|17/03/2022;
Notification|Accepted - CEP remains valid|19/04/2021;
New application|CEP granted|24/11/2020
1656 Moxidectin for veterinary use, With butylhydroxytoluene, Process II LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN 100020920;100029633 CEP 2021-423 - Rev 01 2024/04/22 Valid 21/03/2027 Chemical 2024/04/22 Minor revision|CEP granted|22/04/2024;
Minor revision|Accepted - CEP remains valid|28/04/2023;
New application|CEP granted|21/03/2022
2174 Cladribine HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO., LTD. Jingmen City CN 100020377;100029131 CEP 2023-104 - Rev 00 2024/04/22 Valid 22/04/2029 Chemical 2024/04/22 New application|CEP granted|22/04/2024
627 Nifedipine SHOUGUANG FUKANG PHARMACEUTICAL CO., LTD. Shouguang City CN 100017920;100052986 CEP 2022-402 - Rev 00 2024/04/22 Valid 22/04/2029 Chemical 2024/04/22 New application|CEP granted|22/04/2024
2375 Raloxifene hydrochloride AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100046306;100076393 CEP 2022-165 - Rev 00 2024/04/22 Valid 22/04/2029 Chemical 2024/04/22 New application|CEP granted|22/04/2024
2988 Fingolimod hydrochloride EMCURE PHARMACEUTICALS LIMITED Pune IN 100011677;100022645 CEP 2022-413 - Rev 00 2024/04/22 Valid 22/04/2029 Chemical 2024/04/22 New application|CEP granted|22/04/2024
798 Fusidic acid JOYANG LABORATORIES Yancheng CN 100033417;100052265 CEP 2014-046 - Rev 01 2024/04/22 Valid Chemical 2024/04/22 Minor revision|CEP granted|22/04/2024;
Renewal|CEP granted|25/06/2020
2675 Irinotecan hydrochloride trihydrate FRESENIUS KABI ONCOLOGY LIMITED Kalyani IN 100011513;100018607 CEP 2017-234 - Rev 03 2024/04/22 Valid Chemical 2024/10/08 Minor revision|Accepted - CEP remains valid|08/10/2024;
Renewal|CEP granted|22/04/2024;
Major revision|Accepted - CEP remains valid|25/10/2023;
Minor revision|CEP granted|02/09/2022;
Notification|Accepted - CEP remains valid|14/04/2022;
Minor revision|Accepted - CEP remains valid|01/06/2021;
Minor revision|CEP granted|09/10/2020
1208 Fenbendazole for veterinary use, Process 2 Shaanxi Hanjiang Pharmaceutical Group Co., Ltd. Hanzhong CN 100012369;100079669 CEP 2018-250 - Rev 02 2024/04/22 Valid Chemical 2024/04/22 Renewal|CEP granted|22/04/2024;
Minor revision|CEP granted|28/11/2022
1073 Biotin DSM Nutritional Products Ltd. Kaiseraugst CH 100012007;100022521 CEP 2001-405 - Rev 06 2024/04/22 Valid Chemical 2024/04/22 Minor revision|CEP granted|22/04/2024;
Minor revision|CEP granted|16/01/2023;
Minor revision|CEP granted|02/02/2022
2015 Ebastine BAL PHARMA LIMITED Bengaluru IN 100016398;100041736 CEP 2013-051 - Rev 02 2024/04/22 Valid Chemical 2024/04/22 Notification|CEP granted|22/04/2024;
Minor revision|CEP granted|28/11/2022
627 Nifedipine Moehs Iberica S.L. Rubi ES 100029092;100068825 CEP 1996-105 - Rev 05 2024/04/22 Valid Chemical 2024/04/22 Minor revision|CEP granted|22/04/2024
1575 Tiapride hydrochloride Laboratorios Espinos Y Bofill S.A. (LEBSA) Cornellà ES 100021595;100030302 CEP 2018-066 - Rev 01 2024/04/19 Valid Chemical 2024/04/19 Renewal|CEP granted|19/04/2024;
Minor revision|Accepted - CEP remains valid|03/02/2022
3087 Ticagrelor PHARMARESOURCES (KAIYUAN) COMPANY LIMITED Kaiyuan City CN 100037212;100058809 CEP 2021-362 - Rev 00 2024/04/19 Valid 19/04/2029 Chemical 2024/04/19 New application|CEP granted|19/04/2024
1103 Fentanyl citrate AREVIPHARMA GMBH Radebeul DE 100011616;100022155 CEP 2007-340 - Rev 02 2024/04/19 Valid Chemical 2024/04/19 Administrative procedure|CEP granted|19/04/2024;
Minor revision|Accepted - CEP remains valid|15/04/2024;
Notification|Accepted - CEP remains valid|17/02/2021
2765 Eplerenone JPN PHARMA PVT LTD Boisar IN 100024390;100061494 CEP 2021-373 - Rev 00 2024/04/19 Valid 19/04/2029 Chemical 2024/04/19 New application|CEP granted|19/04/2024
1114 Iohexol DIVI'S LABORATORIES LIMITED Hyderabad IN 100011666;100052116 CEP 2022-240 - Rev 00 2024/04/19 Valid 19/04/2029 Chemical 2024/09/26 Minor revision|Accepted - CEP remains valid|26/09/2024;
New application|CEP granted|19/04/2024
2993 Nilotinib hydrochloride monohydrate RAVI BIOLIFE PRIVATE LTD. Mumbai IN 100048404;100086771 CEP 2022-425 - Rev 00 2024/04/19 Valid 19/04/2029 Chemical 2024/04/19 New application|CEP granted|19/04/2024
718 Glibenclamide, Non-micronised, micronised USV PRIVATE LIMITED Mumbai IN 100006251;100010851 CEP 2000-090 - Rev 05 2024/04/19 Valid Chemical 2024/04/19 Minor revision|CEP granted|19/04/2024;
Notification|Rejected|22/01/2024

数据库说明:

当前数据更新日期:2025年03月28日。
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