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
2296 Pantoprazole sodium sesquihydrate, DC grade VASUDHA PHARMA CHEM LIMITED Hyderabad IN 100011811;100018603 CEP 2023-445 - Rev 00 2024/04/17 Valid 17/04/2029 Chemical 2024/04/17 New application|CEP granted|17/04/2024
1096 Doxepin hydrochloride R L FINE CHEM PVT. LTD. Bengaluru IN 100016723;100067511 CEP 2022-355 - Rev 00 2024/04/17 Valid 17/04/2029 Chemical 2024/04/17 New application|CEP granted|17/04/2024
1146 Roxithromycin ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD. Shangyu CN 100022562;100031241 CEP 2017-064 - Rev 01 2024/04/17 Valid Chemical 2024/04/17 Renewal|CEP granted|17/04/2024
1211 Fenticonazole nitrate RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A. Milano IT 100000942;100001718 CEP 2014-374 - Rev 01 2024/04/17 Valid Chemical 2024/04/17 Monograph revision|CEP granted|17/04/2024;
Minor revision|Accepted - CEP remains valid|22/06/2021;
Renewal|CEP granted|10/02/2021
922 Ketoprofen, Process N DONG BANG FUTURE TECH & LIFE CO., LTD. Hwaseong-si KR 100024414;100042624 CEP 2017-194 - Rev 03 2024/04/17 Valid Chemical 2024/04/17 Minor revision|CEP granted|17/04/2024;
Renewal|CEP granted|01/02/2024;
Minor revision|CEP granted|25/04/2023
1452 Nicotine NICOBRAND LIMITED Coleraine GB 100002321;100006571 CEP 2017-101 - Rev 04 2024/04/17 Valid Chemical 2024/04/17 Minor revision|CEP granted|17/04/2024;
Renewal|CEP granted|11/12/2023
2013 Ciprofibrate SANOFI WINTHROP INDUSTRIE Gentilly FR 100011564;100021551 CEP 2011-120 - Rev 05 2024/04/17 Valid Chemical 2024/04/17 Notification|CEP granted|17/04/2024;
Monograph revision|CEP granted|30/01/2023;
Notification|CEP granted|12/07/2022;
Minor revision|CEP granted|20/08/2020
803 Amiodarone hydrochloride PMC ISOCHEM Vert Le Petit FR 100011861;100020972 CEP 1997-090 - Rev 11 2024/04/17 Valid Chemical 2024/04/17 Minor revision|CEP granted|17/04/2024;
Notification|CEP granted|23/11/2022
2131 Tamsulosin hydrochloride DONG BANG FUTURE TECH & LIFE CO., LTD. Hwaseong-si KR 100024414;100042624 CEP 2022-178 - Rev 00 2024/04/16 Valid 16/04/2029 Chemical 2024/04/16 New application|CEP granted|16/04/2024
2420 Tiotropium bromide monohydrate JEWIM PHARMACEUTICAL (SHANDONG) CO., LTD. Taian CN 100048112;100079597 CEP 2023-214 - Rev 00 2024/04/16 Valid 16/04/2029 Chemical 2024/04/16 New application|CEP granted|16/04/2024
2191 Atorvastatin calcium, Process-VIII SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2013-094 - Rev 04 2024/04/16 Valid Chemical 2024/04/16 Major revision|CEP granted|16/04/2024;
Minor revision|CEP granted|21/02/2023;
Monograph revision|CEP granted|02/08/2022;
Notification|Accepted - CEP remains valid|17/01/2022;
Notification|CEP granted|25/02/2021
2766 Exemestane CURIA SPAIN S.A.U. Boecillo ES 100011649;100019586 CEP 2017-159 - Rev 06 2024/04/16 Valid Chemical 2024/04/16 Transfer of holdership|CEP granted|16/04/2024;
Renewal|CEP granted|20/03/2024;
Notification|Accepted - CEP remains valid|17/11/2021;
Notification|CEP granted|27/08/2021;
Administrative procedure|CEP granted|01/06/2021;
Minor revision|CEP granted|07/05/2021;
Monograph revision|Accepted - CEP remains valid|24/07/2020
726 Levamisole Hydrochloride CHANGZHOU YABANG-QH PHARMACHEM CO., LTD. Chunjiang Town CN 100019146;100027908 CEP 2022-376 - Rev 00 2024/04/16 Valid 16/04/2029 Chemical 2024/04/16 New application|CEP granted|16/04/2024
2182 Trimebutine maleate PMC ISOCHEM Vert Le Petit FR 100011861;100020972 CEP 2018-026 - Rev 01 2024/04/15 Valid Chemical 2024/04/15 Renewal|CEP granted|15/04/2024;
Minor revision|Accepted - CEP remains valid|21/11/2023
2570 Desloratadine HAINAN POLY PHARMACEUTICAL COMPANY LIMITED Haikou CN 100024397;100033569 CEP 2018-174 - Rev 02 2024/04/15 Valid Chemical 2024/04/15 Renewal|CEP granted|15/04/2024;
Minor revision|CEP granted|16/03/2022
1448 Metoprolol succinate IPCA LABORATORIES LIMITED Mumbai IN 100011685;100018680 CEP 2004-028 - Rev 05 2024/04/15 Valid Chemical 2024/04/15 Minor revision|CEP granted|15/04/2024;
Minor revision|Accepted - CEP remains valid|04/12/2023;
Minor revision|CEP granted|11/04/2023
978 Calcium folinate hydrate GMT Fine Chemicals SA Couvet CH 100019396;100028159 CEP 2004-009 - Rev 04 2024/04/15 Valid Chemical 2024/04/15 Minor revision|CEP granted|15/04/2024;
Minor revision|Accepted - CEP remains valid|29/01/2024;
Minor revision|Accepted - CEP remains valid|12/08/2022;
Minor revision|Accepted - CEP remains valid|01/12/2021;
Minor revision|Accepted - CEP remains valid|15/03/2021
2125 Doxazosin mesilate NIFTY LABS PVT. LTD. Hyderabad IN 100014767;100042749 CEP 2022-257 - Rev 00 2024/04/15 Valid 15/04/2029 Chemical 2024/04/15 New application|CEP granted|15/04/2024
2258 Olanzapine TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL 100000702;100060842 CEP 2012-161 - Rev 03 2024/04/15 Valid Chemical 2024/04/15 Notification|CEP granted|15/04/2024;
Minor revision|CEP granted|04/01/2022;
Administrative procedure|CEP granted|12/08/2020;
Notification|Abandoned|05/08/2020
919 Ipratropium bromide MELODY HEALTHCARE PVT. LTD. Mumbai IN 100014822;100073679 CEP 2017-302 - Rev 03 2024/04/15 Valid Chemical 2024/04/15 Renewal|CEP granted|15/04/2024;
Major revision|CEP granted|10/01/2023;
Minor revision|Accepted - CEP remains valid|16/12/2020;
Minor revision|CEP granted|19/06/2020

数据库说明:

当前数据更新日期:2024年04月30日。
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