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
332 Heparin calcium, for parenteral preparations OPOCRIN SpA Corlo Di Formigine IT 100008856;100018068 CEP 2007-211 - Rev 04 2024/07/15 Valid Chemical and TSE 2024/07/15 Notification|CEP granted|15/07/2024
2585 Rizatriptan benzoate TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN 100051463;100090213 CEP 2011-299 - Rev 03 2024/07/15 Valid Chemical 2024/07/15 Notification|CEP granted|15/07/2024
2737 Zolmitriptan TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN 100051463;100090213 CEP 2020-422 - Rev 02 2024/07/15 Valid 18/05/2027 Chemical 2024/07/15 Notification|CEP granted|15/07/2024;
Minor revision|CEP granted|13/10/2023;
Minor revision|Accepted - CEP remains valid|03/08/2023;
New application|CEP granted|18/05/2022
595 Bisacodyl DISHMAN CARBOGEN AMCIS LIMITED Ahmedabad IN 100012005;100062133 CEP 2007-163 - Rev 04 2024/07/15 Valid Chemical 2024/07/15 Notification|CEP granted|15/07/2024;
Minor revision|CEP granted|16/03/2023
185 Potassium chloride K+S MINERALS AND AGRICULTURE GMBH Kassel DE 100020039;100051870 CEP 2010-380 - Rev 05 2024/07/15 Valid Chemical 2024/07/15 Minor revision|CEP granted|15/07/2024;
Minor revision|CEP granted|09/06/2023;
Minor revision|Accepted - CEP remains valid|13/06/2022;
Administrative procedure|CEP granted|10/03/2021;
Minor revision|CEP granted|25/02/2021
193 Sodium chloride K+S MINERALS AND AGRICULTURE GMBH Kassel DE 100020039;100051870 CEP 2007-367 - Rev 03 2024/07/15 Valid Chemical 2024/07/15 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
1710 Bisoprolol fumarate HARMAN FINOCHEM LIMITED Mumbai IN 100011528;100020515 CEP 2014-264 - Rev 02 2024/07/15 Valid Chemical 2024/07/15 Minor revision|CEP granted|15/07/2024;
Major revision|CEP granted|12/10/2022;
Renewal|CEP granted|28/06/2021
379 Cetylpyridinium Chloride DISHMAN CARBOGEN AMCIS LIMITED Ahmedabad IN 100012005;100062133 CEP 2007-029 - Rev 07 2024/07/15 Valid Chemical 2024/07/15 Notification|CEP granted|15/07/2024;
Minor revision|CEP granted|08/11/2023;
Minor revision|CEP granted|03/05/2023
378 Cetrimide DISHMAN CARBOGEN AMCIS LIMITED Ahmedabad IN 100012005;100062133 CEP 2007-199 - Rev 03 2024/07/15 Valid Chemical 2024/07/15 Notification|CEP granted|15/07/2024;
Minor revision|Accepted - CEP remains valid|22/05/2023;
Minor revision|CEP granted|22/06/2022
2573 Candesartan cilexetil, Process II TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN 100051463;100090213 CEP 2019-303 - Rev 02 2024/07/15 Valid 02/04/2025 Chemical 2024/07/15 Notification|CEP granted|15/07/2024;
Major revision|CEP granted|12/10/2022
1031 Sodium picosulfate DISHMAN CARBOGEN AMCIS LIMITED Ahmedabad IN 100012005;100062133 CEP 2020-021 - Rev 02 2024/07/15 Valid 14/12/2025 Chemical 2024/07/15 Notification|CEP granted|15/07/2024;
Minor revision|CEP granted|02/05/2024;
New application|CEP granted|14/12/2020
603 Disulfiram SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN 100032307;100078783 CEP 2019-197 - Rev 01 2024/07/15 Valid 05/07/2026 Chemical 2024/07/15 Major revision|CEP granted|15/07/2024;
Minor revision|Abandoned|18/03/2024
1559 Risperidone TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN 100051463;100090213 CEP 2006-060 - Rev 06 2024/07/12 Valid Chemical 2024/07/12 Notification|CEP granted|12/07/2024;
Minor revision|Accepted - CEP remains valid|23/10/2020
1651 Clarithromycin TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN 100051463;100090213 CEP 2005-266 - Rev 06 2024/07/12 Valid Chemical 2024/07/12 Notification|CEP granted|12/07/2024;
Major revision|CEP granted|23/11/2023;
Minor revision|Accepted - CEP remains valid|14/01/2021
2219 Lansoprazole TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN 100051463;100090213 CEP 2008-240 - Rev 03 2024/07/12 Valid Chemical 2024/07/12 Notification|CEP granted|12/07/2024
942 Omeprazole, Micronised and sieved grade ESTEVE QUIMICA S.A. Barcelona ES 100002266;100056508 CEP 1998-145 - Rev 11 2024/07/12 Valid Chemical 2024/07/12 Minor revision|CEP granted|12/07/2024;
Notification|Accepted - CEP remains valid|20/04/2023;
Transfer of holdership|CEP granted|16/03/2022;
Notification|Accepted - CEP remains valid|04/11/2021;
Notification|CEP granted|24/03/2020
1558 Propofol, PFL EMCURE PHARMACEUTICALS LIMITED Pune IN 100011677;100022690 CEP 2024-066 - Rev 00 2024/07/12 Valid 12/07/2029 Chemical 2024/07/12 New application|CEP granted|12/07/2024
1335 Itraconazole TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN 100051463;100090213 CEP 2005-269 - Rev 06 2024/07/12 Valid Chemical 2024/07/12 Notification|CEP granted|12/07/2024;
Minor revision|CEP granted|16/09/2022
1065 Alprazolam TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN 100051463;100090213 CEP 2008-060 - Rev 02 2024/07/12 Valid Chemical 2024/07/12 Notification|CEP granted|12/07/2024
1756 Lamotrigine TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN 100051463;100090213 CEP 2009-157 - Rev 02 2024/07/12 Valid Chemical 2024/07/12 Notification|CEP granted|12/07/2024

数据库说明:

当前数据更新日期:2024年07月17日。
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