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 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 2026/03/20 Minor revision|Accepted - CEP remains valid|20/03/2026;
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 2026/01/26 Monograph revision|Accepted - CEP remains valid|26/01/2026;
Minor revision|CEP granted|22/07/2025;
Notification|CEP granted|26/04/2022;
Notification|CEP granted|25/06/2020
1710 Bisoprolol fumarate MEHTA API PRIVATE LIMITED Boisar IN 100020995;100042931 CEP 2023-208 - Rev 00 2025/07/22 Valid 22/07/2030 Chemical 2025/07/22 New application|CEP granted|22/07/2025
2631 Rosuvastatin calcium, Micronised MANKIND PHARMA LIMITED New Delhi IN 100040218;100065486 CEP 2022-060 - Rev 02 2025/07/22 Valid 26/06/2028 Chemical 2025/07/23 Administrative procedure|CEP granted|23/07/2025;
Notification|CEP granted|10/06/2025;
New application|CEP granted|26/06/2023
1376 Triamcinolone CORAL DRUGS PRIVATE LIMITED New Delhi IN 100019182;100042823 CEP 2022-370 - Rev 00 2025/07/22 Valid 22/07/2030 Chemical 2025/07/23 New application|CEP granted|23/07/2025
2768 Fluticasone furoate, Process I HOVIONE FARMACIENCIA S.A. Loures PT 100001467;100000315 CEP 2024-146 - Rev 00 2025/07/22 Valid 22/07/2030 Chemical 2025/07/23 New application|CEP granted|23/07/2025
383 Chlorobutanol hemihydrate OLPHA AS Olaine LV 100002509;100000997 CEP 2013-148 - Rev 02 2025/07/22 Valid Chemical 2025/07/23 Minor revision|CEP granted|23/07/2025;
Notification|CEP granted|28/10/2024;
Minor revision|Accepted - CEP remains valid|18/12/2020
1302 Ciclopirox olamine OLON S.P.A. Rodano IT 100012085;100019537 CEP 1999-085 - Rev 09 2025/07/22 Valid Chemical 2025/07/23 Minor revision|CEP granted|23/07/2025;
Minor revision|Accepted - CEP remains valid|04/07/2024;
Minor revision|Accepted - CEP remains valid|15/03/2023;
Minor revision|Accepted - CEP remains valid|28/03/2022;
Minor revision|CEP granted|13/09/2021;
Minor revision|CEP granted|11/01/2021
67 Folic acid hydrate SRI KRISHNA PHARMACEUTICALS LIMITED Hyderabad IN 100015104;100023787 CEP 1997-076 - Rev 13 2025/07/22 Valid Chemical 2025/07/23 Minor revision|CEP granted|23/07/2025;
Minor revision|CEP granted|05/03/2024;
Monograph revision|Accepted - CEP remains valid|07/09/2022;
Minor revision|CEP granted|20/05/2021
3132 Mirabegron VASUDHA PHARMA CHEM LIMITED Hyderabad IN 100011811;100018603 CEP 2024-198 - Rev 00 2025/07/22 Valid 22/07/2030 Chemical 2025/07/23 New application|CEP granted|23/07/2025
68 Atropine sulfate FLOWCHEM PHARMA PRIVATE LIMITED Sri Sathya Sai IN 100054650;100096908 CEP 2023-209 - Rev 00 2025/07/22 Valid 22/07/2030 Chemical 2025/07/23 New application|CEP granted|23/07/2025
1243 Mitoxantrone hydrochloride WUHAN CALMLAND PHARMACEUTICALS CO., LTD. Wuhan CN 100049301;100083738 CEP 2023-342 - Rev 00 2025/07/22 Valid 22/07/2030 Chemical 2025/07/23 New application|CEP granted|23/07/2025
1742 Esketamine hydrochloride AREVIPHARMA GMBH Radebeul DE 100011616;100022155 CEP 2022-404 - Rev 01 2025/07/22 Valid 21/06/2028 Chemical 2025/07/23 Minor revision|CEP granted|23/07/2025;
New application|CEP granted|21/06/2023
2334 Letrozole, Form-III HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2012-145 - Rev 03 2025/07/22 Valid Chemical 2025/07/23 Minor revision|CEP granted|23/07/2025;
Minor revision|CEP granted|22/02/2023;
Monograph revision|Accepted - CEP remains valid|27/01/2021
685 Povidone, K17 BOAI NKY MEDICAL HOLDINGS LTD. Jiaozuo CN 100051122;100089488 CEP 2024-236 - Rev 00 2025/07/22 Valid 22/07/2030 Chemical 2025/07/23 New application|CEP granted|23/07/2025

数据库说明:

当前数据更新日期:2026年05月27日。
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