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
2932 Rivaroxaban TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2021-036 - Rev 02 2025/03/05 Valid 16/06/2028 Chemical 2025/03/05 Notification|CEP granted|05/03/2025;
Minor revision|CEP granted|21/10/2024;
New application|CEP granted|16/06/2023
2777 Pregabalin, Process II HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2021-197 - Rev 03 2025/03/05 Valid 20/09/2026 Chemical 2025/11/17 Minor revision|Accepted - CEP remains valid|17/11/2025;
Minor revision|Accepted - CEP remains valid|21/07/2025;
Minor revision|CEP granted|05/03/2025;
Minor revision|CEP granted|03/05/2024;
Minor revision|CEP granted|25/10/2023;
Minor revision|Accepted - CEP remains valid|28/07/2022;
New application|CEP granted|20/09/2021
937 Minoxidil ZHEJIANG CDMO PHARMACEUTICAL CO., LTD Jinhua CN 100051857;100091157 CEP 2024-392 - Rev 00 2025/03/05 Valid 05/03/2030 Chemical 2025/04/14 Minor revision|Accepted - CEP remains valid|14/04/2025;
New application|CEP granted|05/03/2025
2631 Rosuvastatin calcium, Process 4 MOREPEN LABORATORIES LIMITED Baddi IN 100017843;100026642 CEP 2025-007 - Rev 00 2025/03/05 Valid 05/03/2030 Chemical 2025/03/05 New application|CEP granted|05/03/2025
1655 Mitomycin TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2007-124 - Rev 05 2025/03/04 Valid Chemical 2025/03/04 Notification|CEP granted|04/03/2025;
Minor revision|Accepted - CEP remains valid|02/03/2023;
Notification|Rejected|03/02/2023;
Notification|CEP granted|04/01/2022;
Notification|Accepted - CEP remains valid|29/07/2020
572 Timolol maleate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 1998-147 - Rev 12 2025/03/04 Valid Chemical 2025/03/04 Notification|CEP granted|04/03/2025;
Minor revision|Accepted - CEP remains valid|02/07/2024;
Notification|CEP granted|24/03/2022;
Notification|CEP granted|20/12/2021;
Minor revision|CEP granted|16/07/2021;
Notification|Accepted - CEP remains valid|23/10/2020
931 Metformin Hydrochloride WANBURY LIMITED Vashi, Navi Mumbai IN 100021364;100030068 CEP 1998-079 - Rev 12 2025/03/04 Valid Chemical 2025/03/04 Minor revision|CEP granted|04/03/2025;
Minor revision|CEP granted|03/11/2023;
Notification|Accepted - CEP remains valid|07/01/2022;
Notification|CEP granted|10/08/2021
2269 Sevoflurane SHANDONG NEW TIME PHARMACEUTICAL CO., LTD. Linyi CN 100025540;100034769 CEP 2012-234 - Rev 01 2025/03/04 Valid Chemical 2025/03/04 Minor revision|CEP granted|04/03/2025;
Notification|Accepted - CEP remains valid|28/08/2020
2296 Pantoprazole sodium sesquihydrate HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2008-289 - Rev 05 2025/03/04 Valid Chemical 2025/09/12 Minor revision|Accepted - CEP remains valid|12/09/2025;
Minor revision|CEP granted|04/03/2025;
Minor revision|CEP granted|02/05/2024;
Minor revision|Accepted - CEP remains valid|16/02/2023;
Minor revision|CEP granted|21/04/2021
2296 Pantoprazole sodium sesquihydrate ASSURGEN PHARMA PVT LTD Lalamkoduru Village IN 100048048;100079469 CEP 2018-199 - Rev 01 2025/03/04 Valid Chemical 2025/03/04 Renewal|CEP granted|04/03/2025
1788 Methylergometrine maleate TAPI CZECH INDUSTRIES S.R.O. Opava CZ 100051642;100090678 CEP 2012-405 - Rev 02 2025/03/04 Valid Chemical 2025/03/04 Notification|CEP granted|04/03/2025;
Notification|Accepted - CEP remains valid|05/03/2024;
Minor revision|Accepted - CEP remains valid|28/08/2023;
Minor revision|CEP granted|12/09/2022
2732 Dienogest, Micronised HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO., LTD. Ezhou City CN 100015482;100024200 CEP 2023-045 - Rev 01 2025/03/04 Valid 15/02/2029 Chemical 2025/03/04 Minor revision|CEP granted|04/03/2025;
New application|CEP granted|15/02/2024
2541 Quetiapine Fumarate IOL CHEMICALS AND PHARMACEUTICALS LTD Ludhiana IN 100017919;100037377 CEP 2023-102 - Rev 00 2025/03/04 Valid 04/03/2030 Chemical 2025/03/04 New application|CEP granted|04/03/2025
735 Prednisolone sodium phosphate AVIK PHARMACEUTICAL LIMITED Vapi IN 100023327;100041968 CEP 2023-025 - Rev 00 2025/03/04 Valid 04/03/2030 Chemical 2025/03/04 New application|CEP granted|04/03/2025
1496 Cassia oil, Rectified FREY + LAU GMBH Henstedt-Ulzburg DE 100017333;100026131 CEP 2024-103 - Rev 00 2025/03/04 Valid 04/03/2030 Herbal 2025/03/04 New application|CEP granted|04/03/2025
2940 Terpin monohydrate DESTILERÍAS MUÑOZ GÁLVEZ, S.A. Murcia ES 100022404;100031089 CEP 2023-143 - Rev 00 2025/03/04 Valid 04/03/2030 Chemical 2025/03/04 New application|CEP granted|04/03/2025
3139 Brivaracetam YANGZHOU AURISCO PHARMACEUTICAL CO., LTD. Yangzhou City CN 100048379;100080110 CEP 2024-375 - Rev 00 2025/03/03 Valid 03/03/2030 Chemical 2025/03/03 New application|CEP granted|03/03/2025
1368 Ramipril, Process 2 ZHEJIANG CHANGMING PHARMACEUTICAL CO., LTD. Taizhou CN 100022703;100031392 CEP 2012-379 - Rev 02 2025/03/03 Valid Chemical 2025/08/11 Minor revision|Accepted - CEP remains valid|11/08/2025;
Minor revision|CEP granted|03/03/2025;
Minor revision|Accepted - CEP remains valid|18/03/2024;
Minor revision|CEP granted|14/10/2022;
Minor revision|Accepted - CEP remains valid|13/08/2021
1450 Mupirocin TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2010-317 - Rev 04 2025/03/03 Valid Chemical 2025/03/03 Notification|CEP granted|03/03/2025;
Minor revision|Accepted - CEP remains valid|27/11/2023;
Minor revision|CEP granted|05/11/2021
1451 Mupirocin calcium TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2008-158 - Rev 04 2025/02/28 Valid Chemical 2025/02/28 Notification|CEP granted|28/02/2025;
Minor revision|CEP granted|01/04/2022

数据库说明:

当前数据更新日期:2025年12月09日。
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