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
2760 Brimonidine tartrate SYMED LABS LIMITED Hyderabad IN 100018727;100090820 CEP 2018-124 - Rev 01 2025/12/11 Valid Chemical 2025/12/11 Renewal|CEP granted|11/12/2025
2307 Modafinil ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 CEP 2014-073 - Rev 01 2025/12/11 Valid Chemical 2025/12/11 Minor revision|CEP granted|11/12/2025;
Minor revision|Accepted - CEP remains valid|06/07/2022;
Renewal|CEP granted|14/01/2021
2064 Chondroitin sulfate sodium, Process A and B BIOIBERICA, S.A.U. Palafolls ES 100000136;100043853 CEP 2001-063 - Rev 07 2025/12/11 Valid TSE 2025/12/11 Minor revision|CEP granted|11/12/2025;
Minor revision|CEP granted|26/10/2022;
Major revision|CEP granted|24/03/2022
1012 Famotidine GEDEON RICHTER PLC. Budapest HU 100000640;100001653 CEP 1999-054 - Rev 04 2025/12/11 Valid Chemical 2025/12/11 Minor revision|CEP granted|11/12/2025;
Minor revision|CEP granted|18/02/2022
601 Dimenhydrinate SHANGHAI WONDER PHARMACEUTICAL CO., LTD Shanghai CN 100020697;100029440 CEP 2020-110 - Rev 02 2025/12/11 Valid 03/03/2027 Chemical 2025/12/11 Minor revision|CEP granted|11/12/2025;
Notification|Accepted - CEP remains valid|07/07/2025;
Minor revision|CEP granted|15/02/2024;
New application|CEP granted|03/03/2022
1648 Thioctic acid CADCHEM LABORATORIES LIMITED Chandigarh IN 100039011;100083960 CEP 2024-419 - Rev 00 2025/12/11 Valid 11/12/2030 Chemical 2025/12/11 New application|CEP granted|11/12/2025
1648 Thioctic acid KINSY S.L. Murcia ES 100025606;100057039 CEP 2024-321 - Rev 00 2025/12/11 Valid 11/12/2030 Chemical 2025/12/11 New application|CEP granted|11/12/2025
2445 Adapalene MAITHRI DRUGS PRIVATE LIMITED Bonthapally Village IN 100020971;100029680 CEP 2023-462 - Rev 00 2025/12/11 Valid 11/12/2030 Chemical 2025/12/11 New application|CEP granted|11/12/2025
1699 Mesalazine, Pubagang site ZHEJIANG HENGKANG PHARMACEUTICAL CO., LTD. Sanmen CN 100034135;100082085 CEP 2021-400 - Rev 01 2025/12/10 Valid 17/12/2026 Chemical 2025/12/10 Minor revision|CEP granted|10/12/2025;
Minor revision|Accepted - CEP remains valid|04/10/2024;
New application|CEP granted|17/12/2021
2866 Gefitinib, Micronised SYNTHON B.V. Nijmegen NL 100001342;100005475 CEP 2016-154 - Rev 01 2025/12/10 Valid Chemical 2025/12/10 Minor revision|CEP granted|10/12/2025;
Notification|Accepted - CEP remains valid|06/07/2022;
Renewal|CEP granted|07/06/2022;
Minor revision|Accepted - CEP remains valid|21/06/2021
2127 Clobetasol propionate AVIK PHARMACEUTICAL LIMITED Vapi IN 100023327;100041968 CEP 2009-315 - Rev 03 2025/12/10 Valid Chemical 2025/12/10 Minor revision|CEP granted|10/12/2025;
Notification|Accepted - CEP remains valid|13/09/2022;
Monograph revision|CEP granted|04/06/2020
1104 Fluoxetine hydrochloride TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 1997-042 - Rev 13 2025/12/10 Valid Chemical 2025/12/10 Notification|CEP granted|10/12/2025;
Notification|CEP granted|12/03/2025;
Notification|Accepted - CEP remains valid|02/12/2024;
Minor revision|CEP granted|22/06/2023;
Notification|Accepted - CEP remains valid|15/03/2022;
Notification|CEP granted|20/12/2021;
Monograph revision|CEP granted|28/01/2021
2372 Esomeprazole magnesium trihydrate HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2014-286 - Rev 02 2025/12/10 Valid Chemical 2025/12/10 Minor revision|CEP granted|10/12/2025;
Minor revision|CEP granted|21/07/2025;
Renewal|CEP granted|16/03/2022;
Minor revision|CEP granted|05/07/2021
1103 Fentanyl citrate VERANOVA, L.P. West Deptford US 100012273;100018937 CEP 2005-104 - Rev 05 2025/12/10 Valid Chemical 2025/12/10 Notification|CEP granted|10/12/2025;
Notification|CEP granted|30/08/2023;
Minor revision|CEP granted|28/01/2022
1075 Budesonide, Micronised VAMSI LABS LIMITED Solapur IN 100014747;100096958 CEP 2024-441 - Rev 00 2025/12/10 Valid 10/12/2030 Chemical 2025/12/10 New application|CEP granted|10/12/2025
2280 Fexofenadine hydrochloride SYNERGENE ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN 100038855;100091886 CEP 2023-294 - Rev 00 2025/12/10 Valid 10/12/2030 Chemical 2025/12/10 New application|CEP granted|10/12/2025
1796 Sucralfate MSN LIFE SCIENCES PRIVATE LIMITED Bhiknoor Village IN 100018316;100070723 CEP 2024-342 - Rev 00 2025/12/10 Valid 10/12/2030 Chemical 2025/12/10 New application|CEP granted|10/12/2025
2422 Oseltamivir phosphate, Crystal Form A RUYUAN HEC PHARM CO., LTD. Shaoguan CN 100023129;100031882 CEP 2024-404 - Rev 00 2025/12/10 Valid 10/12/2030 Chemical 2025/12/10 New application|CEP granted|10/12/2025
2918 Everolimus, 0.2% BHT HISUN PHARMACEUTICAL (HANGZHOU) CO., LTD. Hangzhou City CN 100012542;100060684 CEP 2024-314 - Rev 00 2025/12/10 Valid 10/12/2030 Chemical 2025/12/10 New application|CEP granted|10/12/2025
2268 Selamectin for veterinary use LIVZON NEW NORTH RIVER PHARMACEUTICAL CO., LTD. Qingyuan City CN 100020572;100029321 CEP 2017-070 - Rev 01 2025/12/09 Valid Chemical 2025/12/09 Minor revision|CEP granted|09/12/2025;
Minor revision|Accepted - CEP remains valid|29/10/2024;
Renewal|CEP granted|02/05/2023;
Minor revision|CEP granted|16/02/2021

数据库说明:

当前数据更新日期:2025年12月13日。
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