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
926 Levonorgestrel, Non-micronised and micronised HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO., LTD. Ezhou City CN 100015482;100024200 CEP 2022-199 - Rev 01 2025/11/13 Valid 19/05/2028 Chemical 2025/11/13 Minor revision|CEP granted|13/11/2025;
New application|CEP granted|19/05/2023
2223 Glimepiride, Micronised USV PRIVATE LIMITED Mumbai IN 100006251;100010851 CEP 2023-130 - Rev 01 2025/11/13 Valid 07/11/2028 Chemical 2025/11/13 Minor revision|CEP granted|13/11/2025;
New application|CEP granted|07/11/2023
2779 Solifenacin succinate, Process II, form-I, micronised and non-micronised ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 CEP 2025-401 - Rev 00 2025/11/13 Valid 13/11/2030 Chemical 2025/11/13 New application|CEP granted|13/11/2025
521 Phenytoin sodium HARMAN FINOCHEM LIMITED Mumbai IN 100011528;100020515 CEP 2016-038 - Rev 01 2025/11/13 Valid Chemical 2025/11/13 Minor revision|CEP granted|13/11/2025;
Renewal|CEP granted|11/01/2023;
Notification|CEP granted|01/03/2021;
Minor revision|CEP granted|24/07/2020
2127 Clobetasol propionate, Micronised, non-micronised FARMABIOS S.p.A Gropello Cairoli IT 100011643;100021232 CEP 2011-135 - Rev 04 2025/11/13 Valid Chemical 2025/11/13 Major revision|CEP granted|13/11/2025;
Administrative procedure|CEP granted|17/12/2021;
Minor revision|CEP granted|10/12/2021;
Monograph revision|Accepted - CEP remains valid|16/07/2020
2736 Imatinib mesilate, Form-β ZHEJIANG AUSUN PHARMACEUTICAL CO., LTD. Taizhou CN 100014719;100023221 CEP 2023-303 - Rev 01 2025/11/12 Valid 05/03/2030 Chemical 2025/11/12 Minor revision|CEP granted|12/11/2025;
New application|CEP granted|05/03/2025
917 Ichthammol, ICHTHYOL OESTERREICHISCHE ICHTHYOL GES.M.B.H. & CO. KG Reith bei Seefeld AT 100022779;100079288 CEP 2025-374 - Rev 00 2025/11/12 Valid 12/11/2030 Chemical 2025/11/12 New application|CEP granted|12/11/2025
1751 Fosinopril sodium HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2013-018 - Rev 03 2025/11/12 Valid Chemical 2025/11/12 Minor revision|CEP granted|12/11/2025;
Notification|Accepted - CEP remains valid|14/10/2024;
Minor revision|CEP granted|29/11/2023;
Monograph revision|CEP granted|28/03/2022;
Renewal|CEP granted|19/02/2021;
Minor revision|CEP granted|25/08/2020
2577 Oxcarbazepine ASSURGEN PHARMA PRIVATE LIMITED Lalamkoduru Village IN 100048048;100079469 CEP 2023-450 - Rev 00 2025/11/12 Valid 12/11/2030 Chemical 2025/11/12 New application|CEP granted|12/11/2025
546 Chlortalidone MENADIONA, S.L. Palafolls ES 100015162;100023846 CEP 2017-285 - Rev 02 2025/11/10 Valid Chemical 2025/11/10 Administrative procedure|CEP granted|10/11/2025;
Renewal|CEP granted|05/03/2024;
Monograph revision|Accepted - CEP remains valid|12/04/2022
1649 Azithromycin ANUH PHARMA LTD. Mumbai IN 100021566;100030259 CEP 2021-143 - Rev 02 2025/11/10 Valid 13/07/2028 Chemical 2025/11/10 Administrative procedure|CEP granted|10/11/2025;
Minor revision|CEP granted|22/01/2025;
New application|CEP granted|13/07/2023
1734 Terbinafine hydrochloride QUIMICA SINTETICA S.A. Alcala De Henares ES 100012121;100019020 CEP 2012-269 - Rev 02 2025/11/10 Valid Chemical 2025/11/10 Minor revision|CEP granted|10/11/2025
3137 Dapagliflozin propylene glycol monohydrate KRKA TOVARNA ZDRAVIL D.D. NOVO MESTO Novo mesto SI 100000627;100009540 CEP 2025-193 - Rev 00 2025/11/10 Valid 10/11/2030 Chemical 2025/11/10 New application|CEP granted|10/11/2025
274 Erythromycin ethylsuccinate, Powder, micronised ERCROS S.A. Aranjuez ES 100016091;100024873 CEP 2002-136 - Rev 09 2025/11/10 Valid Chemical 2025/11/10 Administrative procedure|CEP granted|10/11/2025;
Minor revision|CEP granted|02/12/2024
179 Erythromycin ANUH PHARMA LTD. Mumbai IN 100021566;100030259 CEP 2005-205 - Rev 13 2025/11/10 Valid Chemical 2025/11/10 Administrative procedure|CEP granted|10/11/2025;
Notification|CEP granted|08/07/2025;
Notification|Accepted - CEP remains valid|23/12/2024;
Notification|CEP granted|14/09/2023;
Minor revision|CEP granted|10/08/2023;
Minor revision|CEP granted|30/08/2022;
Monograph revision|Accepted - CEP remains valid|22/02/2021;
Notification|CEP granted|30/06/2020;
Notification|CEP granted|26/02/2020
227 Lidocaine hydrochloride monohydrate SHANDONG CHENGHUI SHUANGDA PHARMACEUTICAL CO., LTD. Dezhou City CN 100048410;100080174 CEP 2024-340 - Rev 00 2025/11/10 Valid 10/11/2030 Chemical 2025/11/10 New application|CEP granted|10/11/2025
101 Nitrofurantoin, Macrocrystals MANKIND PHARMA LIMITED New Delhi IN 100040218;100065486 CEP 2019-092 - Rev 04 2025/11/10 Valid Chemical 2025/11/10 Minor revision|CEP granted|10/11/2025;
Renewal|CEP granted|18/06/2025;
Administrative procedure|CEP granted|12/10/2023;
Minor revision|CEP granted|28/09/2023;
Minor revision|Accepted - CEP remains valid|09/08/2023;
Minor revision|Accepted - CEP remains valid|19/08/2021;
Minor revision|Accepted - CEP remains valid|14/04/2021
2423 Valsartan, Essential Amorphous Form, Process-II DR. REDDY'S LABORATORIES LIMITED Hyderabad IN 100003991;100000217 CEP 2025-449 - Rev 00 2025/11/10 Valid 10/11/2030 Chemical 2025/11/10 New application|CEP granted|10/11/2025
193 Sodium chloride K+S MINERALS AND AGRICULTURE GMBH Kassel DE 100020039;100051870 CEP 2007-367 - Rev 04 2025/11/10 Valid Chemical 2025/11/10 Minor revision|CEP granted|10/11/2025;
Minor revision|CEP granted|15/07/2024;
Minor revision|Accepted - CEP remains valid|24/04/2023;
Minor revision|Accepted - CEP remains valid|13/06/2022;
Minor revision|Accepted - CEP remains valid|24/02/2021
3049 Etonogestrel INDUSTRIALE CHIMICA S.R.L. Saronno IT 100011692;100020331 CEP 2025-195 - Rev 00 2025/11/10 Valid 10/11/2030 Chemical 2025/11/10 New application|CEP granted|10/11/2025

数据库说明:

当前数据更新日期:2026年04月07日。
©2006-2026 DrugFuture->Certificates of Suitability to the monographs of European Pharmacopoeia, EDQM