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
3139 Brivaracetam, Non-micronised and micronised ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN 100011833;100018698 CEP 2024-064 - Rev 02 2026/02/18 Valid 25/02/2030 Chemical 2026/02/18 Minor revision|CEP granted|18/02/2026;
Minor revision|CEP granted|04/12/2025;
New application|CEP granted|25/02/2025
2778 Sitagliptin phosphate monohydrate QUIMICA SINTETICA S.A. Alcala De Henares ES 100012121;100019020 CEP 2024-564 - Rev 00 2026/02/18 Valid 18/02/2031 Chemical 2026/02/18 New application|CEP granted|18/02/2026
1449 Mometasone furoate, Micronised and non-micronised BREATHGREEN PHARMACEUTICAL CO. LTD. Zaozhuang CN 100048781;100081153 CEP 2025-361 - Rev 00 2026/02/18 Valid 18/02/2031 Chemical 2026/02/18 New application|CEP granted|18/02/2026
2932 Rivaroxaban DIJIA PHARMACEUTICAL GROUP CO., LTD. Weihai CN 100048717;100100668 CEP 2024-174 - Rev 00 2026/02/18 Valid 18/02/2031 Chemical 2026/02/18 New application|CEP granted|18/02/2026
1909 Sodium polystyrene sulfonate VALENS PHARMACHEM PRIVATE LIMITED Nadiad IN 100052857;100093188 CEP 2025-058 - Rev 00 2026/02/18 Valid 18/02/2031 Chemical 2026/02/18 New application|CEP granted|18/02/2026
572 Timolol maleate TIANJIN MINXIANG PHARMACEUTICAL CO., LTD. Jinghai CN 100034356;100054454 CEP 2024-458 - Rev 00 2026/02/18 Valid 18/02/2031 Chemical 2026/02/18 New application|CEP granted|18/02/2026
2631 Rosuvastatin calcium, Process I BIOCON LIMITED Bengaluru IN 100011487;100018595 CEP 2015-114 - Rev 04 2026/02/16 Valid Chemical 2026/02/16 Minor revision|CEP granted|16/02/2026;
Minor revision|CEP granted|21/10/2024;
Notification|Accepted - CEP remains valid|20/03/2023;
Major revision|CEP granted|27/01/2023;
Major revision|CEP granted|22/02/2022;
Renewal|CEP granted|16/08/2021;
Monograph revision|CEP granted|13/08/2020
2154 Telmisartan, Non-micronised, micronised ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN 100011833;100018698 CEP 2009-077 - Rev 03 2026/02/16 Valid Chemical 2026/02/16 Minor revision|CEP granted|16/02/2026;
Notification|Accepted - CEP remains valid|04/03/2025;
Notification|Accepted - CEP remains valid|12/06/2024;
Minor revision|Accepted - CEP remains valid|05/04/2023;
Notification|Accepted - CEP remains valid|09/06/2022;
Notification|Accepted - CEP remains valid|20/10/2021;
Notification|CEP granted|14/04/2021;
Major revision|Abandoned|23/02/2021;
Minor revision|Accepted - CEP remains valid|23/10/2020
53 Streptomycin sulfate North China Pharmaceutical Huasheng Co., Ltd. Shijiazhuang CN 100021261;100029965 CEP 2001-394 - Rev 04 2026/02/16 Valid Chemical 2026/02/16 Monograph revision|CEP granted|16/02/2026;
Minor revision|Accepted - CEP remains valid|22/07/2024;
Minor revision|CEP granted|29/06/2023;
Minor revision|CEP granted|27/08/2021;
Monograph revision|Accepted - CEP remains valid|12/01/2021
2531 Clopidogrel hydrogen sulfate, Form II, micronised and non-micronised MSN ORGANICS PRIVATE LIMITED Bibinagar Village IN 100012074;100018617 CEP 2015-331 - Rev 01 2026/02/16 Valid Chemical 2026/02/16 Minor revision|CEP granted|16/02/2026;
Minor revision|Accepted - CEP remains valid|11/08/2022;
Renewal|CEP granted|26/01/2022;
Minor revision|CEP granted|01/12/2020
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

数据库说明:

当前数据更新日期:2026年04月03日。
©2006-2026 DrugFuture->Certificates of Suitability to the monographs of European Pharmacopoeia, EDQM