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
14 Calcium carbonate, Sieved grade I (35) OMYA SAS Omey FR 100020502;100081592 CEP 2001-366 - Rev 05 2025/11/21 Valid Chemical 2025/11/21 Minor revision|CEP granted|21/11/2025;
Minor revision|CEP granted|25/05/2021;
Minor revision|CEP granted|08/12/2020
619 Levomenthol FREY + LAU GMBH Henstedt-Ulzburg DE 100017333;100026131 CEP 2019-058 - Rev 01 2025/11/21 Valid Chemical 2025/11/21 Renewal|CEP granted|21/11/2025;
Renewal|Abandoned|04/07/2025;
Notification|Accepted - CEP remains valid|13/08/2021;
Notification|Accepted - CEP remains valid|25/02/2021
2930 Valganciclovir hydrochloride SHANGHAI PHARMA GROUP CHANGZHOU KONY PHARMACEUTICAL CO., LTD. Luoyang Town CN 100020594;100034407 CEP 2024-326 - Rev 00 2025/11/21 Valid 21/11/2030 Chemical 2025/11/21 New application|CEP granted|21/11/2025
260 Amoxicillin trihydrate, Sterile NORTH CHINA PHARMACEUTICAL GROUP SEMISYNTECH CO. LTD. Shijiazhuang CN 100023274;100032418 CEP 2024-583 - Rev 00 2025/11/21 Valid 21/11/2030 Chemical 2025/11/21 New application|CEP granted|21/11/2025
2017 Oxaliplatin SHANDONG BOYUAN PHARMACEUTICAL CO., LTD. Jinan City CN 100037406;100076812 CEP 2013-113 - Rev 01 2025/11/21 Valid Chemical 2025/11/21 Minor revision|CEP granted|21/11/2025
1794 Paclitaxel WUXI TAXUS PHARMACEUTICAL CO. LTD. Wuxi City CN 100052831;100093126 CEP 2024-437 - Rev 00 2025/11/21 Valid 21/11/2030 Chemical 2025/11/21 New application|CEP granted|21/11/2025
1702 Naproxen sodium HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2022-389 - Rev 01 2025/11/19 Valid 13/09/2029 Chemical 2025/11/19 Minor revision|CEP granted|19/11/2025;
New application|CEP granted|16/09/2024
2756 Amorolfine hydrochloride, Nantong site SIEGFRIED AG Zofingen CH 100011797;100022117 CEP 2017-251 - Rev 01 2025/11/19 Valid Chemical 2025/11/19 Minor revision|CEP granted|19/11/2025;
Minor revision|Accepted - CEP remains valid|22/08/2024;
Renewal|CEP granted|11/01/2023
781 Phenoxyethanol ICN POLFA RZESZOW S.A. Rzeszow PL 100000280;100004301 CEP 2023-276 - Rev 01 2025/11/19 Valid 06/05/2029 Chemical 2025/11/19 Minor revision|CEP granted|19/11/2025;
New application|CEP granted|06/05/2024
67 Folic acid hydrate ZHEJIANG SHENGDA BIO-PHARM CO., LTD. Tiantai CN 100024864;100041389 CEP 2023-161 - Rev 01 2025/11/19 Valid 13/11/2029 Chemical 2025/11/19 Notification|CEP granted|19/11/2025;
New application|CEP granted|13/11/2024
2341 Cefpodoxime proxetil, Process 3 QILU ANTIBIOTICS PHARMACEUTICAL CO. LTD. Jinan CN 100033695;100052910 CEP 2020-399 - Rev 02 2025/11/19 Valid Chemical 2025/11/19 Renewal|CEP granted|19/11/2025;
Minor revision|CEP granted|03/01/2025;
Notification|Accepted - CEP remains valid|17/11/2022;
Minor revision|Accepted - CEP remains valid|18/01/2022;
New application|CEP granted|15/03/2021
3087 Ticagrelor, Standard, micronised ZAKŁADY FARMACEUTYCZNE POLPHARMA S.A. Starogard Gdański PL 100000470;100001572 CEP 2020-338 - Rev 04 2025/11/19 Valid 15/05/2028 Chemical 2025/11/19 Notification|CEP granted|19/11/2025;
Minor revision|CEP granted|27/10/2025;
Minor revision|CEP granted|23/08/2024;
Minor revision|CEP granted|17/01/2024;
New application|CEP granted|15/05/2023
2126 Cefepime dihydrochloride monohydrate, Sterile ACS DOBFAR S.P.A. Tribiano IT 100011589;100019524 CEP 2023-021 - Rev 01 2025/11/19 Valid 27/07/2028 Chemical 2025/11/19 Major revision|CEP granted|19/11/2025;
New application|CEP granted|27/07/2023
1131 Methylprednisolone hydrogen succinate HENAN LIHUA PHARMACEUTICAL CO., LTD. Anyang CN 100016183;100024971 CEP 2024-159 - Rev 00 2025/11/17 Valid 17/11/2030 Chemical 2025/11/17 New application|CEP granted|17/11/2025
3095 Dabigatran etexilate mesilate AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100046306;100076393 CEP 2023-382 - Rev 00 2025/11/17 Valid 17/11/2030 Chemical 2025/11/17 New application|CEP granted|17/11/2025
559 Mannitol, For use in the manufacture of parenteral preparations CARGILL S.R.L. Castelmassa IT 100049176;100083235 CEP 2005-019 - Rev 04 2025/11/17 Valid Chemical 2025/11/17 Minor revision|CEP granted|17/11/2025;
Notification|CEP granted|24/06/2025
2932 Rivaroxaban Changzhou Pharmaceutical Factory Changzhou CN 100012704;100018611 CEP 2021-252 - Rev 01 2025/11/17 Valid 12/09/2027 Chemical 2025/11/17 Minor revision|CEP granted|17/11/2025;
Notification|Accepted - CEP remains valid|20/12/2023;
New application|CEP granted|12/09/2022
687 Salbutamol sulfate, Micronised VAMSI LABS LIMITED Solapur IN 100014747;100096958 CEP 2024-328 - Rev 00 2025/11/17 Valid 17/11/2030 Chemical 2025/11/17 New application|CEP granted|17/11/2025
524 Promethazine hydrochloride EMCURE PHARMACEUTICALS LIMITED Pune IN 100011677;100022690 CEP 2024-304 - Rev 00 2025/11/17 Valid 17/11/2030 Chemical 2025/11/17 New application|CEP granted|17/11/2025
1336 Ivermectin, Code iverm11 ZHEJIANG HISUN PHARMACEUTICAL CO., LTD. Taizhou City CN 100011825;100018687 CEP 2025-175 - Rev 01 2025/11/17 Valid 22/08/2030 Chemical 2025/11/17 Minor revision|CEP granted|17/11/2025;
New application|CEP granted|22/08/2025

数据库说明:

当前数据更新日期:2025年12月07日。
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