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
1142 Povidone, iodinated BOAI NKY MEDICAL HOLDINGS LTD. Jiaozuo CN 100051122;100089488 CEP 2025-012 - Rev 00 2025/07/22 Valid 22/07/2030 Chemical 2025/07/22 New application|CEP granted|22/07/2025
2570 Desloratadine, Milled, micronised MOREPEN LABORATORIES LIMITED Baddi IN 100017843;100026642 CEP 2014-302 - Rev 01 2025/07/22 Valid Chemical 2025/07/22 Minor revision|CEP granted|22/07/2025;
Minor revision|Accepted - CEP remains valid|31/01/2023;
Minor revision|Accepted - CEP remains valid|02/07/2021;
Renewal|CEP granted|19/10/2020;
Minor revision|Accepted - CEP remains valid|24/02/2020
829 Hydralazine hydrochloride HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2018-287 - Rev 03 2025/07/22 Valid Chemical 2025/07/22 Renewal|CEP granted|22/07/2025;
Minor revision|CEP granted|20/03/2024;
Minor revision|Accepted - CEP remains valid|29/06/2023;
Monograph revision|CEP granted|24/05/2022;
Minor revision|Accepted - CEP remains valid|22/01/2021
525 Propylthiouracil MACLEODS PHARMACEUTICALS LIMITED Mumbai IN 100021441;100077265 CEP 2015-125 - Rev 02 2025/07/22 Valid Chemical 2025/07/22 Minor revision|CEP granted|22/07/2025;
Notification|Accepted - CEP remains valid|26/11/2024;
Monograph revision|CEP granted|02/10/2023;
Notification|Accepted - CEP remains valid|13/05/2022;
Renewal|CEP granted|01/02/2022;
Minor revision|Accepted - CEP remains valid|16/04/2021
2357 Dydrogesterone, Micronized YANGZHOU AURISCO PHARMACEUTICAL CO., LTD. Yangzhou City CN 100048379;100080110 CEP 2021-460 - Rev 03 2025/07/22 Valid 07/11/2027 Chemical 2025/07/22 Minor revision|CEP granted|22/07/2025;
Minor revision|CEP granted|06/09/2023;
Minor revision|CEP granted|16/03/2023;
New application|CEP granted|07/11/2022
. Lab Lemco Powder OXOID LIMITED Basingstoke GB 100052176;100095427 CEP 2024-283 - Rev 00 2025/07/22 Valid 22/07/2030 TSE 2025/07/22 New application|CEP granted|22/07/2025
1173 Benserazide hydrochloride ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN 100011833;100018698 CEP 2022-200 - Rev 01 2025/07/22 Valid 06/02/2029 Chemical 2025/07/22 Minor revision|CEP granted|22/07/2025;
Minor revision|Accepted - CEP remains valid|13/09/2024;
Notification|Accepted - CEP remains valid|26/03/2024;
New application|CEP granted|06/02/2024
766 Flucytosine DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 2009-091 - Rev 02 2025/07/22 Valid Chemical 2025/07/22 Notification|CEP granted|22/07/2025;
Minor revision|CEP granted|11/01/2022
1075 Budesonide, T Process TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2014-051 - Rev 02 2025/07/22 Valid Chemical 2025/07/22 Notification|CEP granted|22/07/2025;
Notification|CEP granted|20/12/2021;
Notification|Accepted - CEP remains valid|04/12/2020
2762 Capecitabine TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2015-078 - Rev 01 2025/07/22 Valid Chemical 2025/07/22 Notification|CEP granted|22/07/2025;
Renewal|CEP granted|04/01/2022
1210 Fentanyl SIEGFRIED GRAFTON INC. Grafton US 100042515;100070251 CEP 2005-044 - Rev 04 2025/07/22 Valid Chemical 2025/07/22 Notification|CEP granted|22/07/2025;
Notification|Accepted - CEP remains valid|02/04/2024;
Notification|CEP granted|27/08/2021
1173 Benserazide hydrochloride BIOPHORE INDIA PHARMACEUTICALS PRIVATE LIMITED Hyderabad IN 100028906;100063062 CEP 2022-150 - Rev 01 2025/07/22 Valid 18/06/2030 Chemical 2025/07/22 Notification|CEP granted|22/07/2025;
New application|CEP granted|18/06/2025
576 Allopurinol HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2021-074 - Rev 03 2025/07/22 Valid 08/03/2028 Chemical 2025/07/22 Minor revision|CEP granted|22/07/2025;
Minor revision|CEP granted|16/09/2024;
Minor revision|CEP granted|11/08/2023;
Notification|Accepted - CEP remains valid|11/04/2023;
New application|CEP granted|08/03/2023
931 Metformin Hydrochloride MACLEODS PHARMACEUTICALS LIMITED Mumbai IN 100021441;100077265 CEP 2021-311 - Rev 01 2025/07/22 Valid 24/04/2029 Chemical 2025/07/22 Minor revision|CEP granted|22/07/2025;
New application|CEP granted|24/04/2024
1551 Nomegestrol acetate, Nomac grade C TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2015-266 - Rev 02 2025/07/22 Valid Chemical 2025/07/22 Minor revision|CEP granted|22/07/2025;
Notification|CEP granted|20/12/2021
688 Spironolactone, Micronised EUROAPI FRANCE Vertolaye FR 100039327;100061906 CEP 2000-167 - Rev 08 2025/07/22 Valid Chemical 2025/07/22 Minor revision|CEP granted|22/07/2025;
Transfer of holdership|CEP granted|16/12/2021
2154 Telmisartan TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2010-301 - Rev 05 2025/07/22 Valid Chemical 2025/07/22 Notification|CEP granted|22/07/2025;
Notification|CEP granted|18/08/2023;
Notification|CEP granted|20/12/2021;
Minor revision|CEP granted|24/06/2020
2209 Sulbactam sodium, Sterile, Process-II APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2024-231 - Rev 00 2025/07/22 Valid 22/07/2030 Chemical 2025/07/22 New application|CEP granted|22/07/2025
2209 Sulbactam sodium, Sterile ZHUHAI UNITED LABORATORIES CO., LTD. Sanzao Town CN 100022945;100052547 CEP 2024-428 - Rev 00 2025/07/22 Valid 22/07/2030 Chemical 2025/07/22 New application|CEP granted|22/07/2025
1275 Ursodeoxycholic acid, Code 2618 ICE S.P.A. Basaluzzo, Alessandria IT 100015143;100051551 CEP 2010-376 - Rev 03 2025/07/22 Valid Chemical and TSE 2025/07/22 Minor revision|CEP granted|22/07/2025;
Notification|CEP granted|26/04/2022;
Notification|CEP granted|25/06/2020

数据库说明:

当前数据更新日期:2025年12月22日。
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