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
2103 Propafenone hydrochloride TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN 100051463;100090213 CEP 2008-100 - Rev 04 2024/07/11 Valid Chemical 2024/07/11 Notification|CEP granted|11/07/2024;
Minor revision|Accepted - CEP remains valid|09/10/2020
369 Azathioprine Zhejiang Cheng Yi Pharmaceutical Co., Ltd. Wenzhou CN 100012163;100031415 CEP 2006-197 - Rev 02 2024/07/11 Valid Chemical 2024/07/11 Minor revision|CEP granted|11/07/2024
2287 Fluconazole TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN 100051463;100090213 CEP 2007-256 - Rev 05 2024/07/11 Valid Chemical 2024/07/11 Notification|CEP granted|11/07/2024;
Minor revision|Accepted - CEP remains valid|10/08/2023
333 Heparin sodium, For parenteral preparations OPOCRIN SpA Corlo Di Formigine IT 100008856;100018068 CEP 2004-165 - Rev 05 2024/07/11 Valid Chemical 2024/07/11 Notification|CEP granted|11/07/2024;
Notification|CEP granted|08/11/2021;
Major revision|CEP granted|19/08/2020
2124 Loratadine TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN 100051463;100090213 CEP 2007-171 - Rev 05 2024/07/11 Valid Chemical 2024/07/11 Notification|CEP granted|11/07/2024;
Minor revision|CEP granted|07/03/2024;
Minor revision|CEP granted|24/01/2023
2570 Desloratadine TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN 100051463;100090213 CEP 2013-319 - Rev 02 2024/07/11 Valid Chemical 2024/07/11 Notification|CEP granted|11/07/2024;
Minor revision|CEP granted|28/05/2021
2601 Pioglitazone hydrochloride TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN 100051463;100090213 CEP 2012-315 - Rev 01 2024/07/11 Valid Chemical 2024/07/11 Notification|CEP granted|11/07/2024;
Minor revision|Accepted - CEP remains valid|01/06/2021
1241 Mefloquine hydrochloride OLON S.P.A. Rodano IT 100012085;100019537 CEP 2011-099 - Rev 04 2024/07/11 Valid Chemical 2024/07/11 Monograph revision|CEP granted|11/07/2024;
Minor revision|Accepted - CEP remains valid|18/12/2023;
Monograph revision|CEP granted|12/04/2023;
Minor revision|Accepted - CEP remains valid|15/07/2022;
Minor revision|CEP granted|30/03/2021
2154 Telmisartan TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN 100051463;100090213 CEP 2008-256 - Rev 03 2024/07/11 Valid Chemical 2024/07/11 Notification|CEP granted|11/07/2024;
Minor revision|CEP granted|04/10/2023
675 Metronidazole, Micronised WUHAN WUYAO PHARMACEUTICAL CO., LTD. Huangshi City CN 100022200;100030902 CEP 2024-218 - Rev 00 2024/07/11 Valid 11/07/2029 Chemical 2024/07/11 New application|CEP granted|11/07/2024
848 Sodium fusidate JOYANG LABORATORIES Yancheng CN 100033417;100052265 CEP 2021-307 - Rev 01 2024/07/11 Valid 13/04/2028 Chemical 2024/07/11 Minor revision|CEP granted|11/07/2024;
Notification|Accepted - CEP remains valid|26/02/2024;
New application|CEP granted|13/04/2023
2932 Rivaroxaban, Modification-I TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN 100051463;100090213 CEP 2021-259 - Rev 02 2024/07/11 Valid 27/01/2028 Chemical 2024/07/11 Notification|CEP granted|11/07/2024;
Minor revision|CEP granted|18/12/2023;
New application|CEP granted|27/01/2023
2637 Pemetrexed disodium heptahydrate WUHAN CALMLAND PHARMACEUTICALS CO., LTD. Wuhan CN 100049301;100083738 CEP 2017-067 - Rev 02 2024/07/10 Valid Chemical 2024/07/10 Renewal|CEP granted|10/07/2024;
Monograph revision|Accepted - CEP remains valid|02/10/2023;
Notification|Accepted - CEP remains valid|25/03/2022;
Notification|Rejected|11/02/2022;
Minor revision|CEP granted|02/06/2021
2235 Methylphenidate hydrochloride COHANCE LIFESCIENCES LIMITED Mumbai IN 100011755;100090273 CEP 2017-181 - Rev 01 2024/07/10 Valid Chemical 2024/07/10 Notification|CEP granted|10/07/2024;
Minor revision|Accepted - CEP remains valid|23/06/2023;
Notification|Rejected|05/04/2023;
Renewal|CEP granted|12/01/2023;
Minor revision|CEP granted|16/03/2021
729 Naloxone hydrochloride dihydrate SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBH Minden DE 100012159;100022673 CEP 2011-126 - Rev 02 2024/07/10 Valid Chemical 2024/07/10 Minor revision|CEP granted|10/07/2024;
Minor revision|Accepted - CEP remains valid|18/09/2020
925 Levomepromazine maleate COHANCE LIFESCIENCES LIMITED Mumbai IN 100011755;100090273 CEP 2018-144 - Rev 04 2024/07/10 Valid 11/02/2025 Chemical 2024/07/10 Notification|CEP granted|10/07/2024;
Minor revision|Accepted - CEP remains valid|09/04/2024;
Monograph revision|CEP granted|09/08/2023;
Notification|CEP granted|12/02/2021;
Minor revision|CEP granted|07/08/2020
2423 Valsartan, ID: 7611 TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL 100000702;100060842 CEP 2011-121 - Rev 04 2024/07/10 Valid Chemical 2024/07/10 Major revision|CEP granted|10/07/2024;
Notification|CEP granted|04/02/2022;
Minor revision|CEP granted|18/06/2021
77 Dapsone COHANCE LIFESCIENCES LIMITED Mumbai IN 100011755;100090273 CEP 2020-358 - Rev 01 2024/07/10 Valid 17/01/2028 Chemical 2024/07/10 Notification|CEP granted|10/07/2024;
New application|CEP granted|17/01/2023
1275 Ursodeoxycholic acid ZHONGSHAN BELLING BIOTECHNOLOGY CO., LTD. Zhongshan City CN 100039390;100062018 CEP 2018-237 - Rev 01 2024/07/10 Valid Chemical 2024/07/10 Renewal|CEP granted|10/07/2024;
Notification|Accepted - CEP remains valid|26/09/2023
2988 Fingolimod hydrochloride MAPRIMED S.A. Buenos Aires AR 100012039;100018552 CEP 2020-312 - Rev 01 2024/07/10 Valid 28/10/2026 Chemical 2024/07/10 Monograph revision|CEP granted|10/07/2024;
Minor revision|Accepted - CEP remains valid|27/02/2024;
New application|CEP granted|28/10/2021

数据库说明:

当前数据更新日期:2024年07月13日。
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