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
2287 Fluconazole GRANULES INDIA LIMITED Hyderabad IN 100011671;100018694 CEP 2009-075 - Rev 02 2024/06/12 Withdrawn by Holder 2024/08/14 Chemical 2024/06/12
2089 Acarbose HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO., LTD. Hangzhou CN 100016034;100062035 CEP 2009-224 - Rev 05 2024/06/12 Valid Chemical 2024/06/12 Minor revision|CEP granted|12/06/2024;
Minor revision|CEP granted|10/03/2021;
Minor revision|CEP granted|10/12/2020
1472 Sodium hyaluronate, Intrinsic viscosity 1.8 m3/kg, by fermentation, for parenteral administration including intra-articular administration and for intra-ocular use BLOOMAGE BIOTECHNOLOGY CORP., LTD. Jinan CN 100024983;100034173 CEP 2021-220 - Rev 02 2024/06/12 Valid 19/04/2028 Chemical 2024/06/12 Minor revision|CEP granted|12/06/2024;
Minor revision|CEP granted|16/06/2023;
New application|CEP granted|19/04/2023
74 Codeine phosphate hemihydrate, Process 2 ALCALIBER S.A.U. Madrid ES 100020633;100087731 CEP 2021-054 - Rev 03 2024/06/12 Valid 29/03/2027 Chemical 2024/06/12 Minor revision|CEP granted|12/06/2024;
Notification|CEP granted|23/01/2024;
Minor revision|CEP granted|24/07/2023;
New application|CEP granted|29/03/2022
1425 Fosfomycin trometamol ZACH SYSTEM Avrillé FR 100012282;100021396 CEP 2020-370 - Rev 03 2024/06/12 Valid 02/09/2026 Chemical 2025/04/02 Notification|Accepted - CEP remains valid|02/04/2025;
Minor revision|CEP granted|12/06/2024;
Minor revision|CEP granted|03/07/2023;
Notification|Accepted - CEP remains valid|25/11/2022;
Minor revision|CEP granted|09/12/2021;
New application|CEP granted|02/09/2021
3087 Ticagrelor SHENZHEN SALUBRIS PHARMACEUTICALS CO., LTD. Shenzhen City CN 100033629;100087648 CEP 2022-491 - Rev 00 2024/06/12 Valid 12/06/2029 Chemical 2024/06/12 New application|CEP granted|12/06/2024
2230 Latanoprost MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN 100011732;100023530 CEP 2023-113 - Rev 00 2024/06/12 Valid 12/06/2029 Chemical 2024/06/12 New application|CEP granted|12/06/2024
1567 Sodium stearyl fumarate RANK ORGANICS CHEMICAL PVT. LTD. Boisar IN 100049838;100086973 CEP 2023-052 - Rev 00 2024/06/12 Valid 12/06/2029 Chemical 2024/06/12 New application|CEP granted|12/06/2024
2465 Irbesartan, Form-A CPL PHARMACEUTICALS PRIVATE LIMITED Ahmedabad IN 100048075;100079517 CEP 2023-237 - Rev 00 2024/06/12 Valid 12/06/2029 Chemical 2024/06/12 New application|CEP granted|12/06/2024
234 Norethisterone, 202311 BAYER AG Leverkusen DE 100000011;100001505 CEP 2023-427 - Rev 00 2024/06/12 Valid 12/06/2029 Chemical 2024/06/12 New application|CEP granted|12/06/2024
1681 Tramadol hydrochloride SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2002-232 - Rev 07 2024/06/12 Valid Chemical 2024/06/12 Minor revision|CEP granted|12/06/2024;
Minor revision|Accepted - CEP remains valid|20/10/2022
260 Amoxicillin trihydrate INNER MONGOLIA CHANGSHENG PHARMACEUTICAL CO., LTD. Tuoketuo CN 100019603;100028364 CEP 2007-315 - Rev 03 2024/06/12 Valid Chemical 2024/06/12 Minor revision|CEP granted|12/06/2024
2306 Gemcitabine hydrochloride SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2007-021 - Rev 02 2024/06/12 Valid Chemical 2024/06/12 Minor revision|CEP granted|12/06/2024
1359 Pivmecillinam hydrochloride FRESENIUS KABI IPSUM S.R.L. Cassina de’ Pecchi IT 100015105;100057989 CEP 2004-262 - Rev 07 2024/06/12 Valid Chemical 2024/06/12 Minor revision|CEP granted|12/06/2024;
Major revision|CEP granted|01/02/2023;
Minor revision|CEP granted|17/01/2022;
Notification|CEP granted|02/02/2021;
Notification|Accepted - CEP remains valid|05/02/2020
708 Cefalexin monohydrate, Powder, compacted CENTRIENT PHARMACEUTICALS NETHERLANDS B.V. Delft NL 100002351;100005259 CEP 1997-007 - Rev 08 2024/06/12 Valid Chemical 2024/06/12 Notification|CEP granted|12/06/2024;
Minor revision|Accepted - CEP remains valid|25/01/2024;
Minor revision|Accepted - CEP remains valid|13/11/2023;
Notification|Accepted - CEP remains valid|09/12/2021
687 Salbutamol sulfate FDC Limited Mumbai IN 100011646;100021030 CEP 2015-212 - Rev 02 2024/06/12 Valid Chemical 2025/02/06 Minor revision|Accepted - CEP remains valid|06/02/2025;
Minor revision|CEP granted|12/06/2024;
Monograph revision|CEP granted|01/02/2024;
Renewal|CEP granted|04/07/2022
1322 Fenofibrate JIANGSU NHWA PHARMACEUTICAL CO., LTD. Xuzhou City CN 100016628;100080030 CEP 2007-350 - Rev 02 2024/06/12 Valid Chemical 2024/06/12 Major revision|CEP granted|12/06/2024
2132 Torasemide ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Linhai CN 100011833;100018698 CEP 2009-061 - Rev 05 2024/06/12 Valid Chemical 2024/06/12 Minor revision|CEP granted|12/06/2024;
Minor revision|Accepted - CEP remains valid|21/11/2023;
Minor revision|Accepted - CEP remains valid|01/12/2022;
Administrative procedure|CEP granted|21/04/2022;
Major revision|CEP granted|13/04/2022;
Notification|Accepted - CEP remains valid|03/06/2021;
Minor revision|Accepted - CEP remains valid|23/09/2020
2988 Fingolimod hydrochloride ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 CEP 2019-301 - Rev 02 2024/06/12 Valid 10/02/2026 Chemical 2024/06/12 Monograph revision|CEP granted|12/06/2024;
Minor revision|CEP granted|18/11/2022;
Minor revision|Accepted - CEP remains valid|10/12/2021
77 Dapsone EXTROVIS AG Baar CH 100040194;100065405 CEP 2022-379 - Rev 00 2024/06/12 Valid 12/06/2029 Chemical 2024/06/12 New application|CEP granted|12/06/2024

数据库说明:

当前数据更新日期:2025年05月14日。
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