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
1627 Turpentine oil, Rectified FREY + LAU GMBH Henstedt-Ulzburg DE 100017333;100026131 CEP 2019-216 - Rev 02 2025/07/21 Valid Herbal 2025/07/21 Renewal|CEP granted|21/07/2025;
Minor revision|Rejected|14/03/2025;
Major revision|CEP granted|21/03/2023;
Notification|Accepted - CEP remains valid|13/08/2021
1250 Omega-3-acid ethyl esters 90, with 0.03% alpha-tocopherol KINOMEGA BIOPHARM INC. Deyang City CN 100051579;100090542 CEP 2025-216 - Rev 00 2025/07/21 Valid 21/07/2030 Chemical 2025/07/21 New application|CEP granted|21/07/2025
72 Cholecalciferol DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 2009-050 - Rev 04 2025/07/21 Valid Chemical and TSE 2025/07/21 Notification|CEP granted|21/07/2025;
Minor revision|CEP granted|06/12/2024;
Minor revision|CEP granted|20/03/2024
1829 Horse-chestnut dry extract, standardised, DER 5-7:1 BERNETT SRL Milano IT 100021863;100031972 CEP 2019-055 - Rev 01 2025/07/21 Valid Herbal 2025/07/21 Renewal|CEP granted|21/07/2025;
Notification|Accepted - CEP remains valid|15/05/2024;
Monograph revision|Accepted - CEP remains valid|28/03/2024;
Notification|Accepted - CEP remains valid|06/08/2021
1324 Flecainide acetate APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2017-183 - Rev 02 2025/07/21 Valid Chemical 2025/07/21 Minor revision|CEP granted|21/07/2025;
Notification|CEP granted|13/12/2023;
Minor revision|Accepted - CEP remains valid|20/11/2023;
Renewal|CEP granted|20/04/2023;
Minor revision|CEP granted|15/09/2020
2600 Olmesartan medoxomil, Process-II, BS-BS APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2025-177 - Rev 00 2025/07/21 Valid 21/07/2030 Chemical 2025/07/21 New application|CEP granted|21/07/2025
58 Triamterene DIPHARMA FRANCIS S.R.L. Baranzate IT 100014675;100030401 CEP 2024-567 - Rev 00 2025/07/21 Valid 21/07/2030 Chemical 2025/07/21 New application|CEP granted|21/07/2025
3014 Rotigotine, Polymorph II OLON S.P.A. Rodano IT 100012085;100019537 CEP 2022-040 - Rev 01 2025/07/21 Valid 10/06/2029 Chemical 2025/07/21 Minor revision|CEP granted|21/07/2025;
New application|CEP granted|10/06/2024
217 Vitamin A, Not less than 1.7 MIU/g, palmitate DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 2004-301 - Rev 02 2025/07/18 Valid Chemical 2025/07/18 Notification|CEP granted|18/07/2025;
Minor revision|CEP granted|10/09/2021
217 Vitamin A, Not less than 2.8 MIU/g , acetate DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 2005-069 - Rev 02 2025/07/18 Valid Chemical 2025/07/18 Notification|CEP granted|18/07/2025;
Minor revision|CEP granted|12/07/2021
439 all-rac-alpha-Tocopheryl acetate DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 2001-180 - Rev 02 2025/07/18 Valid Chemical 2025/07/18 Notification|CEP granted|18/07/2025
303 Thiamine hydrochloride DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 1998-131 - Rev 06 2025/07/17 Valid Chemical 2025/07/17 Notification|CEP granted|17/07/2025;
Administrative procedure|CEP granted|20/04/2021;
Minor revision|CEP granted|07/04/2021
531 Thiamine nitrate DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 1999-057 - Rev 06 2025/07/17 Valid Chemical 2025/07/17 Notification|CEP granted|17/07/2025;
Minor revision|CEP granted|26/04/2021
1791 Sodium ascorbate DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 2002-254 - Rev 05 2025/07/17 Valid Chemical 2025/07/17 Notification|CEP granted|17/07/2025;
Monograph revision|Accepted - CEP remains valid|27/07/2023;
Minor revision|CEP granted|17/12/2021
786 Riboflavin sodium phosphate hydrate DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 2023-436 - Rev 01 2025/07/17 Valid 17/12/2029 Chemical 2025/07/17 Notification|CEP granted|17/07/2025;
New application|CEP granted|17/12/2024
292 Riboflavin, Fermentation process DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 2000-088 - Rev 02 2025/07/17 Valid Chemical 2025/07/17 Notification|CEP granted|17/07/2025;
Minor revision|Accepted - CEP remains valid|09/08/2022
942 Omeprazole, Micronised LEE PHARMA LIMITED Hyderabad IN 100014849;100042625 CEP 2007-006 - Rev 05 2025/07/17 Valid Chemical 2025/07/17 Administrative procedure|CEP granted|17/07/2025;
Minor revision|CEP granted|28/05/2025;
Notification|Accepted - CEP remains valid|26/06/2023;
Major revision|CEP granted|23/01/2023
968 Aciclovir OLON S.P.A. Rodano IT 100012085;100019537 CEP 2003-218 - Rev 07 2025/07/17 Valid Chemical 2025/07/17 Minor revision|CEP granted|17/07/2025;
Minor revision|Accepted - CEP remains valid|19/05/2022;
Monograph revision|CEP granted|26/04/2021
67 Folic acid hydrate DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 1996-045 - Rev 07 2025/07/17 Valid Chemical 2025/07/17 Notification|CEP granted|17/07/2025;
Administrative procedure|CEP granted|10/08/2023;
Minor revision|CEP granted|06/07/2023;
Monograph revision|Accepted - CEP remains valid|11/05/2022;
Minor revision|CEP granted|27/04/2021
. Foetal Bovine Serum, Alternative HYCLONE LABORATORIES LLC. Logan US 100012797;100022115 CEP 2000-185 - Rev 04 2025/07/17 Valid TSE 2025/12/11 Major revision|Accepted - CEP remains valid|11/12/2025;
Major revision|Rejected|15/10/2025;
Notification|CEP granted|17/07/2025;
Major revision|CEP granted|23/01/2023;
Notification|Accepted - CEP remains valid|10/05/2022;
Notification|Rejected|25/03/2022;
Notification|CEP granted|24/06/2020

数据库说明:

当前数据更新日期:2025年12月22日。
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