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
1028 Metoprolol tartrate IPCA Laboratories Limited Mumbai IN 100011685;100018680 R1-CEP 2003-091 - Rev 04 2023/03/16 Valid Chemical 2023/03/16 Minor revision|CEP granted|16/03/2023
595 Bisacodyl DISHMAN CARBOGEN AMCIS LIMITED Ahmedabad IN 100062133 R1-CEP 2007-163 - Rev 03 2023/03/16 Valid Chemical 2023/03/16 Minor revision|CEP granted|16/03/2023
896 Deferoxamine mesilate, Produced by a synthetic process EXCELLA GMBH & CO. KG Feucht DE 100012030;100020739 R1-CEP 2009-401 - Rev 04 2023/03/16 Valid Chemical 2023/03/16 Minor revision|CEP granted|16/03/2023
2465 Irbesartan ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 R1-CEP 2011-153 - Rev 04 2023/03/16 Valid Chemical 2023/03/16 Major revision|CEP granted|16/03/2023;
Minor revision|CEP granted|30/08/2021
992 Cefuroxime sodium, Sterile ZHEJIANG DONGYING PHARMACEUTICAL CO., LTD. Shaoxing CN 100047603;100078635 R0-CEP 2021-308 - Rev 00 2023/03/15 Valid 15/03/2028 Chemical 2023/03/15 New application|CEP granted|15/03/2023
1286 Alfacalcidol CARBOGEN AMCIS B.V. Veenendaal NL R1-CEP 1998-097 - Rev 09 2023/03/15 Valid Chemical and TSE 2023/03/15 Notification|CEP granted|15/03/2023;
Notification|CEP granted|09/03/2022
330 Gelatin, Limed hide gelatin ITALGEL S.P.A. Santa Vittoria D'alba IT R1-CEP 2000-312 - Rev 03 2023/03/15 Valid TSE 2023/03/15 Notification|CEP granted|15/03/2023;
Notification|CEP granted|07/04/2022
577 Amoxicillin sodium, Sterile ZHUHAI UNITED LABORATORIES CO., LTD. Sanzao Town CN 100022945;100052547 R1-CEP 2013-125 - Rev 03 2023/03/15 Valid Chemical 2023/03/15 Major revision|CEP granted|15/03/2023;
Major revision|CEP granted|05/08/2022;
Major revision|CEP granted|06/11/2020
1104 Fluoxetine hydrochloride ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 R1-CEP 2013-199 - Rev 02 2023/03/15 Valid Chemical 2024/04/16 Minor revision|Accepted - CEP remains valid|16/04/2024;
Minor revision|Accepted - CEP remains valid|12/12/2023;
Minor revision|CEP granted|15/03/2023;
Minor revision|Accepted - CEP remains valid|01/03/2021;
Monograph revision|CEP granted|14/12/2020;
Minor revision|Accepted - CEP remains valid|09/06/2020
199 Oxytetracycline dihydrate YANGZHOU LIBERTY PHARMACEUTICAL CO., LTD. Yangzhou CN 100023496;100032638 R1-CEP 2017-105 - Rev 00 2023/03/15 Valid Chemical 2023/03/15 Renewal|CEP granted|15/03/2023
1511 Enoxolone Alps Pharmaceutical Ind. Co., Ltd. Hida JP 100011598;100021193 R0-CEP 2016-098 - Rev 01 2023/03/14 Expired 2023/08/02 Chemical 2023/03/14
38 Levodopa HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 R0-CEP 2022-320 - Rev 00 2023/03/14 Valid 14/03/2028 Chemical 2023/03/14 New application|CEP granted|14/03/2023
1416 Dihydroergocristine mesilate CURIA ITALY S.R.L. Rozzano, Milano IT R1-CEP 2000-073 - Rev 07 2023/03/14 Valid Chemical 2023/03/14 Minor revision|CEP granted|14/03/2023;
Notification|CEP granted|05/08/2021;
Minor revision|CEP granted|18/03/2020
749 Vincristine sulfate MINAKEM HIGH POTENT Mont-Saint-Guibert BE 100011725;100022401 R1-CEP 2004-048 - Rev 05 2023/03/14 Valid Chemical 2023/03/14 Minor revision|CEP granted|14/03/2023;
Minor revision|Accepted - CEP remains valid|13/07/2022
2064 Chondroitin sulfate sodium, Terrestrial avian origin ROVAFARM ARGENTINA S.A. Partido de La Matanza AR R1-CEP 2007-058 - Rev 02 2023/03/14 Valid Chemical 2023/03/14 Major revision|CEP granted|14/03/2023;
Notification|CEP granted|19/11/2020
1548 Nimesulide MANGALAM DRUGS & ORGANICS LTD. Mumbai IN R1-CEP 2011-310 - Rev 01 2023/03/13 Valid Chemical 2023/03/13 Minor revision|CEP granted|13/03/2023
199 Oxytetracycline dihydrate CHIFENG PHARMACEUTICAL CO., LTD. Chifeng CN R1-CEP 2002-035 - Rev 03 2023/03/13 Valid Chemical 2023/03/13 Minor revision|CEP granted|13/03/2023
199 Oxytetracycline dihydrate, Process B CHIFENG PHARMACEUTICAL CO., LTD. Chifeng CN R1-CEP 2009-053 - Rev 02 2023/03/13 Valid Chemical 2023/03/13 Minor revision|CEP granted|13/03/2023
1045 Sulpiride ICROM S.R.L. Concorezzo IT 100022464;100031145 R1-CEP 2011-074 - Rev 03 2023/03/13 Valid Chemical 2023/03/13 Minor revision|CEP granted|13/03/2023;
Notification|CEP granted|27/11/2020;
Minor revision|CEP granted|25/02/2020
2600 Olmesartan medoxomil MACLEODS PHARMACEUTICALS LIMITED Mumbai IN 100021441;100077265 R1-CEP 2014-196 - Rev 01 2023/03/13 Valid Chemical 2023/03/13 Minor revision|CEP granted|13/03/2023;
Renewal|CEP granted|07/04/2022;
Minor revision|CEP granted|09/08/2021;
Minor revision|CEP granted|27/01/2021;
Minor revision|CEP granted|06/08/2020

数据库说明:

当前数据更新日期:2024年05月05日。
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