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
1696 Flunixin meglumine for veterinary use, Process II ZHEJIANG HISOAR PHARMACEUTICAL CO., LTD. Taizhou CN 100011830;100018613 CEP 2016-133 - Rev 01 2026/02/16 Valid Chemical 2026/02/16 Minor revision|CEP granted|16/02/2026;
Notification|Accepted - CEP remains valid|20/10/2022;
Renewal|CEP granted|14/04/2022
2777 Pregabalin ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 CEP 2016-220 - Rev 01 2026/02/16 Valid Chemical 2026/02/16 Minor revision|CEP granted|16/02/2026;
Minor revision|Accepted - CEP remains valid|03/07/2024;
Notification|Accepted - CEP remains valid|04/08/2023;
Minor revision|Accepted - CEP remains valid|15/03/2023;
Renewal|CEP granted|13/06/2022
3087 Ticagrelor DIVI'S LABORATORIES LIMITED Hyderabad IN 100011666;100052116 CEP 2022-072 - Rev 01 2026/02/16 Valid 24/10/2028 Chemical 2026/02/16 Minor revision|CEP granted|16/02/2026;
New application|CEP granted|25/10/2023
928 Lomustine UMICORE ARGENTINA S.A. Buenos Aires AR 100022008;100030708 CEP 2021-132 - Rev 01 2026/02/16 Valid 10/11/2027 Chemical 2026/02/16 Minor revision|CEP granted|16/02/2026;
New application|CEP granted|10/11/2022
1332 Isoprenaline hydrochloride WUHAN WUYAO PHARMACEUTICAL CO., LTD. Huangshi CN 100022200;100030902 CEP 2024-485 - Rev 00 2026/02/16 Valid 16/02/2031 Chemical 2026/02/16 New application|CEP granted|16/02/2026
140 Ethinylestradiol, Micronised, non-micronised ZHEJIANG XIANJU PHARMACEUTICAL CO., LTD. Taizhou CN 100022759;100031459 CEP 2020-326 - Rev 01 2026/02/16 Valid Chemical 2026/02/16 Renewal|CEP granted|16/02/2026;
New application|CEP granted|26/04/2021
20 Dextromethorphan hydrobromide monohydrate EXEMED PHARMACEUTICALS Vadodara IN 100019154;100027915 CEP 2021-257 - Rev 01 2026/02/16 Valid 20/12/2028 Chemical 2026/02/16 Monograph revision|CEP granted|16/02/2026;
New application|CEP granted|20/12/2023
1694 Gemfibrozil ZHEJIANG EXCEL PHARMACEUTICAL CO., LTD. Taizhou CN 100012381;100021159 CEP 2008-118 - Rev 02 2026/02/13 Valid Chemical 2026/02/13 Minor revision|CEP granted|13/02/2026;
Minor revision|CEP granted|20/09/2021
996 Clindamycin phosphate XINYU PHARMACEUTICAL CO., LTD. Suzhou CN 100020532;100056331 CEP 2011-019 - Rev 03 2026/02/13 Valid Chemical 2026/02/13 Minor revision|CEP granted|13/02/2026;
Minor revision|CEP granted|27/11/2024
2541 Quetiapine Fumarate SYNTHIMED LABS PRIVATE LIMITED Derabassi IN 100052287;100092080 CEP 2015-178 - Rev 02 2026/02/13 Valid Chemical 2026/02/13 Minor revision|CEP granted|13/02/2026;
Minor revision|CEP granted|02/09/2024;
Minor revision|Accepted - CEP remains valid|25/10/2023;
Renewal|CEP granted|19/07/2021
929 Loperamide hydrochloride VASUDHA PHARMA CHEM LIMITED Hyderabad IN 100011811;100018603 CEP 2013-333 - Rev 04 2026/02/13 Valid Chemical 2026/02/13 Minor revision|CEP granted|13/02/2026;
Minor revision|CEP granted|11/03/2024;
Notification|CEP granted|30/01/2023;
Minor revision|CEP granted|02/03/2022;
Renewal|CEP granted|06/01/2021
2254 Moxifloxacin hydrochloride, Monohydrate, micronised and non-micronised MSN PHARMACHEM PRIVATE LIMITED Sangareddy IN 100014794;100023345 CEP 2007-355 - Rev 06 2026/02/13 Valid Chemical 2026/02/13 Minor revision|CEP granted|13/02/2026;
Minor revision|CEP granted|02/08/2024;
Administrative procedure|CEP granted|22/09/2021;
Minor revision|Accepted - CEP remains valid|14/09/2021
203 Polymyxin B sulfate, Pyrogen-free HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO., LTD. Hangzhou CN 100016034;100024777 CEP 2024-585 - Rev 00 2026/02/13 Valid 13/02/2031 Chemical and TSE 2026/02/13 New application|CEP granted|13/02/2026
2741 Sulfadimethoxine ANUH PHARMA LIMITED Mumbai IN 100021566;100030259 CEP 2024-522 - Rev 01 2026/02/13 Valid 04/12/2030 Chemical 2026/03/04 Notification|Accepted - CEP remains valid|04/03/2026;
Minor revision|CEP granted|13/02/2026;
New application|CEP granted|04/12/2025
2857 Trazodone hydrochloride ZYDUS LIFESCIENCES LIMITED Vadodara IN 100005979;100074301 CEP 2022-396 - Rev 01 2026/02/13 Valid 28/02/2029 Chemical 2026/02/13 Minor revision|CEP granted|13/02/2026;
New application|CEP granted|28/02/2024
1674 Mesna SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN 100032307;100099917 CEP 2015-299 - Rev 02 2026/02/13 Valid Chemical 2026/02/13 Minor revision|CEP granted|13/02/2026;
Major revision|CEP granted|20/08/2024;
Renewal|CEP granted|03/02/2022
2787 Esomeprazole magnesium dihydrate HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2014-333 - Rev 04 2026/02/12 Valid Chemical 2026/02/12 Minor revision|CEP granted|12/02/2026;
Notification|CEP granted|06/06/2025;
Minor revision|CEP granted|08/01/2025;
Notification|CEP granted|07/03/2023;
Renewal|CEP granted|26/04/2022;
Minor revision|CEP granted|11/03/2020
890 Clonazepam CENTAUR PHARMACEUTICALS PRIVATE LIMITED Mumbai IN 100018245;100028824 CEP 2006-030 - Rev 04 2026/02/12 Valid Chemical 2026/02/12 Monograph revision|CEP granted|12/02/2026;
Major revision|Accepted - CEP remains valid|30/09/2024;
Notification|CEP granted|20/10/2023;
Major revision|CEP granted|28/04/2023
936 Midazolam WAVELENGTH ENTERPRISES LTD. Petah Tikva IL 100018877;100092992 CEP 2006-267 - Rev 09 2026/02/12 Valid Chemical 2026/02/12 Minor revision|CEP granted|12/02/2026;
Notification|CEP granted|23/10/2024;
Minor revision|CEP granted|05/03/2024;
Minor revision|Accepted - CEP remains valid|02/01/2023;
Minor revision|CEP granted|20/06/2022;
Notification|CEP granted|09/07/2020
2732 Dienogest, Micronised GEDEON RICHTER PLC. Budapest X HU 100000640;100001653 CEP 2020-023 - Rev 01 2026/02/12 Valid 03/05/2027 Chemical 2026/02/12 Major revision|CEP granted|12/02/2026;
New application|CEP granted|03/05/2022

数据库说明:

当前数据更新日期:2026年05月28日。
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