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
931 Metformin Hydrochloride, Process 2 SHANDONG SHOUGUANG BOKANG PHARMACEUTICAL CO., LTD. Yangkou Town CN 100048458;100080267 CEP 2022-495 - Rev 01 2025/10/31 Valid 09/03/2028 Chemical 2025/10/31 Minor revision|CEP granted|31/10/2025;
New application|CEP granted|09/03/2023
2535 Levetiracetam SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2021-034 - Rev 01 2025/10/31 Valid 12/10/2027 Chemical 2025/10/31 Minor revision|CEP granted|31/10/2025;
Minor revision|Accepted - CEP remains valid|04/08/2023;
New application|CEP granted|12/10/2022
2531 Clopidogrel hydrogen sulfate, Form II ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO., LTD. Dongyang City CN 100022699;100078733 CEP 2020-165 - Rev 02 2025/10/31 Valid Chemical 2025/10/31 Renewal|CEP granted|31/10/2025;
Minor revision|CEP granted|06/07/2021;
New application|CEP granted|16/12/2020
2856 Pirfenidone CIPLA LIMITED Mumbai IN 100006004;100018147 CEP 2018-096 - Rev 01 2025/10/31 Valid Chemical 2025/10/31 Renewal|CEP granted|31/10/2025;
Notification|Accepted - CEP remains valid|26/04/2022
1425 Fosfomycin trometamol, FT23 LABIANA PHARMACEUTICALS, S.L.U. Corbera de Llobregat ES 100000356;100010380 CEP 2023-068 - Rev 02 2025/10/31 Valid 19/06/2028 Chemical 2025/10/31 Minor revision|CEP granted|31/10/2025;
Notification|CEP granted|04/03/2024;
New application|CEP granted|19/06/2023
2372 Esomeprazole magnesium trihydrate, Micronised SHIJIAZHUANG LONZEAL PHARMACEUTICALS CO., LTD. Shenze CN 100047734;100078894 CEP 2024-211 - Rev 00 2025/10/31 Valid 31/10/2030 Chemical 2025/10/31 New application|CEP granted|31/10/2025
1753 Iopromide, 202008 BAYER AG Leverkusen DE 100000011;100001505 CEP 2020-273 - Rev 01 2025/10/31 Valid Chemical 2025/10/31 Renewal|CEP granted|31/10/2025;
Minor revision|Accepted - CEP remains valid|29/07/2025;
Minor revision|Accepted - CEP remains valid|28/04/2022;
New application|CEP granted|06/01/2021
1611 Diosmin CHENGDU SHUXI PHARMACEUTICAL CO., LTD. Chengdu City CN 100039379;100061999 CEP 2016-202 - Rev 01 2025/10/31 Valid Chemical 2025/10/31 Major revision|CEP granted|31/10/2025;
Renewal|CEP granted|13/09/2022
335 Hydrocortisone, Micronised SYMBIOTEC PHARMALAB PRIVATE LIMITED Indore IN 100018972;100095999 CEP 2018-054 - Rev 03 2025/10/30 Valid Chemical 2025/10/30 Minor revision|CEP granted|30/10/2025;
Renewal|CEP granted|15/04/2024;
Minor revision|Accepted - CEP remains valid|28/11/2022;
Minor revision|CEP granted|31/08/2020
891 Copovidone, K-value: 27.0-33.0 HUANGSHAN BONSUN PHARMACEUTICALS CO., LTD. Huangshan CN 100039134;100098152 CEP 2019-199 - Rev 01 2025/10/30 Valid Chemical 2025/10/30 Renewal|CEP granted|30/10/2025
1032 Omeprazole sodium CIPLA LIMITED Mumbai IN 100006004;100018147 CEP 2007-276 - Rev 04 2025/10/30 Valid Chemical 2025/10/30 Administrative procedure|CEP granted|30/10/2025;
Minor revision|CEP granted|22/10/2025
1589 Doxylamine hydrogen succinate UNION QUIMICO FARMACEUTICA, S.A Barcelona ES 100000721;100001301 CEP 2004-089 - Rev 07 2025/10/30 Valid Chemical 2025/10/30 Minor revision|CEP granted|30/10/2025;
Notification|Accepted - CEP remains valid|04/11/2021;
Minor revision|CEP granted|21/10/2020
1090 Clobetasone butyrate, Micronised SYMBIOTEC PHARMALAB PRIVATE LIMITED Indore IN 100018972;100095999 CEP 2012-282 - Rev 01 2025/10/30 Valid Chemical 2025/10/30 Minor revision|CEP granted|30/10/2025;
Notification|Accepted - CEP remains valid|01/03/2021;
Notification|Accepted - CEP remains valid|14/12/2020
2992 Lacosamide DIVI'S LABORATORIES LIMITED Hyderabad IN 100011666;100052116 CEP 2020-437 - Rev 03 2025/10/30 Valid 09/05/2027 Chemical 2025/10/30 Minor revision|CEP granted|30/10/2025;
Notification|Rejected|01/10/2025;
Minor revision|CEP granted|27/07/2023;
Administrative procedure|CEP granted|23/05/2022;
New application|CEP granted|10/05/2022
2303 Adrenaline, Site-II TRANSO-PHARM HANDELS GMBH Siek DE 100018331;100027110 CEP 2025-397 - Rev 00 2025/10/30 Valid 30/10/2030 Chemical 2025/10/30 New application|CEP granted|30/10/2025
254 Adrenaline tartrate, Site-II TRANSO-PHARM HANDELS GMBH Siek DE 100018331;100027110 CEP 2025-442 - Rev 00 2025/10/30 Valid 30/10/2030 Chemical 2025/10/30 New application|CEP granted|30/10/2025
3087 Ticagrelor MACLEODS PHARMACEUTICALS LIMITED Mumbai IN 100021441;100077265 CEP 2023-368 - Rev 00 2025/10/30 Valid 30/10/2030 Chemical 2025/10/30 New application|CEP granted|30/10/2025
3095 Dabigatran etexilate mesilate, Form-I DR. REDDY'S LABORATORIES LIMITED Hyderabad IN 100003991;100000217 CEP 2024-004 - Rev 01 2025/10/30 Valid 25/04/2030 Chemical 2025/10/30 Minor revision|CEP granted|30/10/2025;
New application|CEP granted|25/04/2025
2574 Entacapone FERMION OY Espoo FI 100011508;100020280 CEP 2021-156 - Rev 01 2025/10/30 Valid 29/06/2028 Chemical 2025/10/30 Minor revision|CEP granted|30/10/2025;
New application|CEP granted|30/06/2023
1720 Enilconazole for veterinary use, By crystallization AUDEVARD Clichy FR 100014137;100062693 CEP 2022-261 - Rev 01 2025/10/30 Valid 06/10/2027 Chemical 2025/10/30 Minor revision|CEP granted|30/10/2025;
New application|CEP granted|06/10/2022

数据库说明:

当前数据更新日期:2025年12月13日。
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