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
2254 Moxifloxacin hydrochloride, Monohydrate ARAGEN LIFE SCIENCES LIMITED Hyderabad IN 100030840;100052317 CEP 2014-101 - Rev 02 2023/11/23 Valid Chemical 2023/11/23 Minor revision|CEP granted|23/11/2023;
Minor revision|CEP granted|20/06/2023;
Minor revision|Accepted - CEP remains valid|25/01/2023;
Renewal|CEP granted|27/07/2021;
Minor revision|CEP granted|28/05/2021
1651 Clarithromycin MYLAN LABORATORIES LIMITED Hyderabad IN 100011537;100018667 CEP 2005-266 - Rev 05 2023/11/23 Valid Chemical 2023/11/23 Major revision|CEP granted|23/11/2023;
Minor revision|Accepted - CEP remains valid|14/01/2021
1425 Fosfomycin trometamol LABIANA PHARMACEUTICALS, S.L.U. Corbera de Llobregat ES 100000356;100010380 CEP 2012-265 - Rev 04 2023/11/23 Valid Chemical 2023/11/23 Administrative procedure|CEP granted|23/11/2023;
Notification|CEP granted|24/10/2023;
Notification|CEP granted|17/12/2021;
Minor revision|CEP granted|18/10/2021;
Minor revision|Accepted - CEP remains valid|07/04/2020
1420 Enalapril maleate ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Linhai CN 100011833;100018698 CEP 2000-053 - Rev 07 2023/11/23 Valid Chemical 2023/11/23 Minor revision|CEP granted|23/11/2023;
Minor revision|CEP granted|06/12/2022;
Minor revision|Accepted - CEP remains valid|09/10/2020
. Calf Thymus peptide solution SANORELL PHARMA GMBH Eutingen im Gäu DE 100041278;100075148 CEP 2001-139 - Rev 02 2023/11/23 Valid TSE 2023/11/23 Notification|CEP granted|23/11/2023;
Transfer of holdership|CEP granted|11/05/2022
3087 Ticagrelor TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL 100000702;100060842 CEP 2021-225 - Rev 00 2023/11/23 Valid 23/11/2028 Chemical 2023/11/23 New application|CEP granted|23/11/2023
2598 Levofloxacin hemihydrate, Process II QUIMICA SINTETICA S.A. Alcala De Henares ES 100012121;100019020 CEP 2021-284 - Rev 01 2023/11/23 Valid 14/02/2027 Chemical 2023/11/23 Minor revision|CEP granted|23/11/2023;
Minor revision|Accepted - CEP remains valid|13/06/2022;
Notification|Accepted - CEP remains valid|22/03/2022;
New application|CEP granted|14/02/2022
2254 Moxifloxacin hydrochloride ZHEJIANG NHU COMPANY LTD. Shaoxing City CN 100047413;100085979 CEP 2021-411 - Rev 00 2023/11/23 Valid 23/11/2028 Chemical 2023/11/23 New application|CEP granted|23/11/2023
2230 Latanoprost KYOWA PHARMA CHEMICAL CO., LTD. Takaoka JP 100012459;100023387 CEP 2022-107 - Rev 00 2023/11/23 Valid 23/11/2028 Chemical 2023/11/23 New application|CEP granted|23/11/2023
2766 Exemestane, Micronised (Form A), non-micronised SHANDONG ANHONG PHARMACEUTICAL CO., LTD. Dezhou City CN 100014777;100050265 CEP 2016-156 - Rev 01 2023/11/23 Valid Chemical 2023/11/23 Minor revision|CEP granted|23/11/2023;
Renewal|CEP granted|30/05/2022;
Minor revision|CEP granted|13/01/2021;
Monograph revision|CEP granted|23/04/2020
663 Dicloxacillin sodium APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2010-177 - Rev 02 2023/11/21 Valid Chemical 2023/11/21 Notification|CEP granted|21/11/2023;
Minor revision|Accepted - CEP remains valid|06/07/2022;
Minor revision|Accepted - CEP remains valid|18/03/2021
2260 Oxacillin sodium monohydrate APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2007-349 - Rev 05 2023/11/21 Valid Chemical 2023/11/21 Notification|CEP granted|21/11/2023;
Notification|Accepted - CEP remains valid|13/02/2023;
Minor revision|Accepted - CEP remains valid|16/06/2022;
Minor revision|Accepted - CEP remains valid|19/10/2021
260 Amoxicillin trihydrate APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2007-147 - Rev 04 2023/11/21 Valid Chemical 2023/11/21 Notification|CEP granted|21/11/2023;
Notification|Accepted - CEP remains valid|13/02/2023;
Minor revision|Accepted - CEP remains valid|16/06/2022;
Minor revision|Accepted - CEP remains valid|18/10/2021
2541 Quetiapine Fumarate MEGAFINE PHARMA (P) LIMITED Mumbai IN 100011550;100021133 CEP 2014-198 - Rev 01 2023/11/21 Valid Chemical 2023/11/21 Minor revision|CEP granted|21/11/2023
168 Ampicillin trihydrate APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2007-358 - Rev 04 2023/11/21 Valid Chemical 2023/11/21 Notification|CEP granted|21/11/2023;
Minor revision|Accepted - CEP remains valid|23/06/2022;
Minor revision|Accepted - CEP remains valid|26/05/2021;
Minor revision|Accepted - CEP remains valid|09/03/2021
2287 Fluconazole APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2007-071 - Rev 05 2023/11/21 Valid Chemical 2023/11/21 Notification|CEP granted|21/11/2023;
Minor revision|CEP granted|18/08/2023;
Monograph revision|Accepted - CEP remains valid|02/05/2023;
Minor revision|Accepted - CEP remains valid|24/02/2022;
Minor revision|CEP granted|24/06/2020
2346 Flucloxacillin magnesium octahydrate APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2008-011 - Rev 03 2023/11/21 Valid Chemical 2023/11/21 Notification|CEP granted|21/11/2023;
Minor revision|Accepted - CEP remains valid|08/08/2022
1359 Pivmecillinam hydrochloride APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2007-229 - Rev 04 2023/11/21 Valid Chemical 2023/11/21 Notification|CEP granted|21/11/2023;
Minor revision|Accepted - CEP remains valid|07/06/2022;
Minor revision|Accepted - CEP remains valid|25/02/2021
668 Flucloxacillin sodium monohydrate APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2003-055 - Rev 10 2023/11/21 Valid Chemical 2023/11/21 Notification|CEP granted|21/11/2023;
Notification|Accepted - CEP remains valid|13/02/2023;
Monograph revision|CEP granted|17/06/2022;
Minor revision|Accepted - CEP remains valid|24/09/2021;
Minor revision|Accepted - CEP remains valid|26/05/2021;
Minor revision|Accepted - CEP remains valid|24/09/2020
577 Amoxicillin sodium, Sterile APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2008-002 - Rev 02 2023/11/21 Valid Chemical 2023/11/21 Notification|CEP granted|21/11/2023;
Minor revision|Accepted - CEP remains valid|08/02/2023

数据库说明:

当前数据更新日期:2023年11月28日。
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