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
1075 Budesonide TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2019-266 - Rev 01 2025/03/10 Valid 09/03/2027 Chemical 2025/03/10 Notification|CEP granted|10/03/2025
2858 Mometasone furoate monohydrate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2022-287 - Rev 02 2025/03/10 Valid 20/02/2028 Chemical 2025/03/10 Notification|CEP granted|10/03/2025;
Administrative procedure|CEP granted|07/03/2023;
New application|CEP granted|20/02/2023
1593 Megestrol acetate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2009-086 - Rev 02 2025/03/06 Valid Chemical 2025/03/06 Notification|CEP granted|06/03/2025;
Minor revision|Accepted - CEP remains valid|17/10/2024;
Minor revision|Accepted - CEP remains valid|23/09/2022;
Minor revision|CEP granted|17/12/2021
1237 Maprotiline hydrochloride OLON S.P.A. Rodano IT 100012085;100019537 CEP 2006-290 - Rev 09 2025/03/06 Valid Chemical 2025/03/06 Minor revision|CEP granted|06/03/2025;
Minor revision|CEP granted|21/08/2024;
Minor revision|CEP granted|12/04/2024;
Minor revision|CEP granted|21/03/2022
96 Mercaptopurine monohydrate FERMION OY Espoo FI 100011508;100020280 CEP 2009-074 - Rev 04 2025/03/06 Valid Chemical 2025/03/06 Monograph revision|CEP granted|06/03/2025;
Notification|CEP granted|11/01/2021;
Monograph revision|CEP granted|30/04/2020
1752 Ganciclovir, Anhydrous EXCELLA GMBH & CO. KG Feucht DE 100012030;100020739 CEP 2010-257 - Rev 04 2025/03/06 Valid Chemical 2025/03/06 Minor revision|CEP granted|06/03/2025;
Minor revision|CEP granted|30/09/2021
1750 Fluticasone propionate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2005-209 - Rev 05 2025/03/06 Valid Chemical 2025/03/06 Notification|CEP granted|06/03/2025;
Minor revision|CEP granted|14/10/2024;
Notification|CEP granted|23/11/2021;
Monograph revision|CEP granted|10/06/2021
2600 Olmesartan medoxomil ZHEJIANG TIANYU PHARMACEUTICAL CO., LTD. Taizhou City CN 100012174;100018701 CEP 2013-268 - Rev 03 2025/03/06 Valid Chemical 2025/03/06 Minor revision|CEP granted|06/03/2025;
Minor revision|Accepted - CEP remains valid|25/04/2024;
Notification|Accepted - CEP remains valid|04/08/2023;
Minor revision|Accepted - CEP remains valid|23/02/2023;
Notification|Rejected|30/01/2023;
Minor revision|CEP granted|07/01/2022;
Minor revision|CEP granted|18/02/2021;
Renewal|CEP granted|05/01/2021;
Minor revision|Accepted - CEP remains valid|12/05/2020;
Minor revision|Accepted - CEP remains valid|21/02/2020
1324 Flecainide acetate EMCURE PHARMACEUTICALS LIMITED Pune IN 100011677;100022690 CEP 2018-155 - Rev 05 2025/03/06 Valid Chemical 2025/03/06 Renewal|CEP granted|06/03/2025;
Administrative procedure|CEP granted|28/08/2024;
Minor revision|CEP granted|14/08/2024;
Minor revision|CEP granted|26/10/2023;
Minor revision|CEP granted|19/05/2022
2600 Olmesartan medoxomil, Micronised and non-micronised MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN 100011732;100018657 CEP 2012-070 - Rev 02 2025/03/06 Valid Chemical 2025/03/06 Minor revision|CEP granted|06/03/2025;
Minor revision|Accepted - CEP remains valid|24/02/2021
2757 Aprepitant HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2017-196 - Rev 03 2025/03/06 Valid Chemical 2025/03/06 Notification|CEP granted|06/03/2025;
Renewal|CEP granted|01/03/2024;
Minor revision|CEP granted|17/07/2020
2254 Moxifloxacin hydrochloride HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2017-113 - Rev 02 2025/03/06 Valid Chemical 2025/03/06 Minor revision|CEP granted|06/03/2025;
Minor revision|CEP granted|27/11/2023;
Renewal|CEP granted|02/03/2023;
Minor revision|Accepted - CEP remains valid|30/04/2020
260 Amoxicillin trihydrate, Compacted SHANXI SHUANGYAN PHARMACEUTICAL CO., LTD. Datong CN 100052070;100091614 CEP 2024-539 - Rev 00 2025/03/06 Valid 06/03/2030 Chemical 2025/03/06 New application|CEP granted|06/03/2025
2932 Rivaroxaban MICRO LABS LIMITED Bengaluru IN 100017819;100077269 CEP 2021-318 - Rev 02 2025/03/06 Valid 10/05/2027 Chemical 2025/03/06 Minor revision|CEP granted|06/03/2025;
Minor revision|CEP granted|19/12/2022;
New application|CEP granted|10/05/2022
2598 Levofloxacin hemihydrate ZHEJIANG LANGHUA PHARMACEUTICAL CO., LTD. Linhai CN 100011848;100019493 CEP 2019-111 - Rev 03 2025/03/06 Valid Chemical 2025/03/06 Renewal|CEP granted|06/03/2025;
Minor revision|Accepted - CEP remains valid|07/10/2024;
Minor revision|CEP granted|29/11/2023;
Minor revision|Accepted - CEP remains valid|16/06/2023;
Minor revision|CEP granted|26/09/2022
1075 Budesonide HENAN LIHUA PHARMACEUTICAL CO., LTD. Anyang CN 100016183;100024971 CEP 2021-346 - Rev 01 2025/03/06 Valid 20/02/2028 Chemical 2025/03/06 Minor revision|CEP granted|06/03/2025;
New application|CEP granted|20/02/2023
260 Amoxicillin trihydrate SHANXI SHUANGYAN PHARMACEUTICAL CO., LTD. Datong CN 100052070;100091614 CEP 2024-422 - Rev 00 2025/03/06 Valid 06/03/2030 Chemical 2025/03/06 New application|CEP granted|06/03/2025
2531 Clopidogrel hydrogen sulfate ARENE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100033956;100079880 CEP 2020-042 - Rev 03 2025/03/05 Valid Chemical 2025/12/02 Renewal|Accepted - CEP remains valid|02/12/2025;
Minor revision|CEP granted|05/03/2025;
Minor revision|CEP granted|16/02/2024;
Administrative procedure|CEP granted|09/04/2021;
New application|CEP granted|09/03/2021
693 Tretinoin, Type 2 OLON S.P.A. Rodano IT 100012085;100019537 CEP 2010-034 - Rev 02 2025/03/05 Valid Chemical 2025/03/05 Minor revision|CEP granted|05/03/2025;
Notification|Accepted - CEP remains valid|03/08/2022;
Minor revision|CEP granted|02/07/2021;
Major revision|Accepted - CEP remains valid|09/04/2020
2423 Valsartan, Process-II ZHEJIANG TIANYU PHARMACEUTICAL CO., LTD. Taizhou City CN 100012174;100018701 CEP 2020-389 - Rev 04 2025/03/05 Valid 16/04/2026 Chemical 2025/03/05 Notification|CEP granted|05/03/2025;
Notification|Accepted - CEP remains valid|29/04/2024;
Minor revision|Accepted - CEP remains valid|04/12/2023;
Notification|Rejected|03/11/2023;
Minor revision|CEP granted|28/06/2023;
Notification|Accepted - CEP remains valid|26/01/2023;
Major revision|CEP granted|30/06/2022;
Minor revision|CEP granted|30/06/2021;
New application|CEP granted|16/04/2021

数据库说明:

当前数据更新日期:2025年12月09日。
©2006-2025 DrugFuture->Certificates of Suitability to the monographs of European Pharmacopoeia, EDQM