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
1648 Thioctic acid SUZHOU FUSHILAI PHARMACEUTICAL CO., LTD. Changshu CN 100033468;100052365 CEP 2023-359 - Rev 00 2025/02/03 Valid 03/02/2030 Chemical 2025/02/03 New application|CEP granted|03/02/2025
2423 Valsartan, ID: 7611 TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2011-121 - Rev 05 2025/01/31 Valid Chemical 2025/01/31 Minor revision|CEP granted|31/01/2025;
Major revision|CEP granted|10/07/2024;
Notification|CEP granted|04/02/2022;
Minor revision|CEP granted|18/06/2021
2536 Milbemycin oxime for veterinary use HUBEI HONCH PHARMACEUTICAL CO., LTD. Huanggang CN 100036821;100058182 CEP 2018-025 - Rev 04 2025/01/31 Valid Chemical 2025/01/31 Minor revision|CEP granted|31/01/2025;
Minor revision|Accepted - CEP remains valid|03/12/2024;
Renewal|CEP granted|14/02/2024;
Minor revision|Accepted - CEP remains valid|18/05/2022;
Minor revision|CEP granted|02/06/2020
2825 Tigecycline SAG MANUFACTURING S.L.U. San Agustin de Guadalix ES 100009832;100014254 CEP 2023-015 - Rev 01 2025/01/31 Valid 26/11/2029 Chemical 2025/01/31 Minor revision|CEP granted|31/01/2025;
New application|CEP granted|26/11/2024
1778 Etidronate disodium QUALIX DOT S.L. L’Hospitalet de Llobregat ES 100042575;100087019 CEP 2023-321 - Rev 00 2025/01/31 Valid 31/01/2030 Chemical 2025/01/31 New application|CEP granted|31/01/2025
922 Ketoprofen ANLON HEALTHCARE PVT. LTD. Pipaliya (Sadak) IN 100049220;100083386 CEP 2023-344 - Rev 00 2025/01/31 Valid 31/01/2030 Chemical 2025/01/31 New application|CEP granted|31/01/2025
2574 Entacapone HEC PHARM GMBH Berlin DE 100002583;100009334 CEP 2013-127 - Rev 03 2025/01/31 Valid Chemical 2025/01/31 Notification|CEP granted|31/01/2025;
Notification|Accepted - CEP remains valid|12/03/2024;
Minor revision|Accepted - CEP remains valid|02/01/2024;
Minor revision|CEP granted|06/07/2022;
Monograph revision|CEP granted|28/09/2020
1742 Esketamine hydrochloride SUPRIYA LIFESCIENCE LIMITED Mumbai IN 100015796;100024574 CEP 2018-198 - Rev 01 2025/01/31 Valid 01/03/2026 Chemical 2025/01/31 Minor revision|CEP granted|31/01/2025
1030 Minocycline hydrochloride dihydrate ZHEJIANG MEDICINE CO., LTD. Shaoxing CN 100022357;100084942 CEP 2022-195 - Rev 00 2025/01/30 Valid 30/01/2030 Chemical 2025/01/30 New application|CEP granted|30/01/2025
2779 Solifenacin succinate Yuki Gosei Kogyo Co., Ltd. Tokyo JP 100012281;100061902 CEP 2023-361 - Rev 00 2025/01/30 Valid 30/01/2030 Chemical 2025/01/30 New application|CEP granted|30/01/2025
2577 Oxcarbazepine AMI LIFESCIENCES PRIVATE LIMITED Karakhadi IN 100021822;100030527 CEP 2022-108 - Rev 02 2025/01/30 Valid 28/06/2029 Chemical 2025/10/10 Minor revision|Accepted - CEP remains valid|10/10/2025;
Minor revision|CEP granted|30/01/2025;
Major revision|CEP granted|03/10/2024;
New application|CEP granted|28/06/2024
260 Amoxicillin trihydrate, Compacted ZHUHAI UNITED LABORATORIES CO., LTD. Sanzao Town CN 100022945;100052547 CEP 2007-191 - Rev 04 2025/01/29 Valid Chemical 2025/01/29 Notification|CEP granted|29/01/2025;
Notification|Accepted - CEP remains valid|13/06/2024;
Minor revision|Accepted - CEP remains valid|15/10/2020
1589 Doxylamine hydrogen succinate SIGMA-ALDRICH IRELAND LTD Arklow IE 100019213;100027978 CEP 2004-167 - Rev 02 2025/01/29 Valid Chemical 2025/01/29 Administrative procedure|CEP granted|29/01/2025;
Minor revision|Accepted - CEP remains valid|24/01/2025;
Notification|Accepted - CEP remains valid|22/07/2021
2270 Sildenafil citrate HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2013-002 - Rev 01 2025/01/29 Valid Chemical 2025/01/29 Minor revision|CEP granted|29/01/2025;
Minor revision|Accepted - CEP remains valid|21/03/2024;
Notification|Accepted - CEP remains valid|24/02/2023;
Minor revision|Accepted - CEP remains valid|03/10/2022;
Minor revision|Accepted - CEP remains valid|14/01/2022
2637 Pemetrexed disodium heptahydrate SUZHOU LIXIN PHARMACEUTICAL CO., LTD. Suzhou CN 100012102;100019568 CEP 2020-398 - Rev 01 2025/01/29 Valid 03/01/2027 Chemical 2025/01/29 Minor revision|CEP granted|29/01/2025;
Monograph revision|Accepted - CEP remains valid|27/03/2023;
New application|CEP granted|03/01/2022
2191 Atorvastatin calcium CHROMO LABORATORIES INDIA PRIVATE LIMITED Pashamylaram IN 100038839;100060978 CEP 2015-288 - Rev 01 2025/01/29 Valid Chemical 2025/01/29 Minor revision|CEP granted|29/01/2025;
Minor revision|Accepted - CEP remains valid|13/06/2024;
Renewal|CEP granted|05/06/2023;
Major revision|CEP granted|18/11/2022;
Notification|Rejected|09/08/2022;
Monograph revision|Accepted - CEP remains valid|15/07/2022;
Minor revision|Accepted - CEP remains valid|08/09/2021;
Minor revision|CEP granted|08/07/2021
252 Zinc oxide GRILLO ZINC POWDER GMBH Goslar DE 100027314;100044134 CEP 2018-254 - Rev 02 2025/01/29 Valid Chemical 2025/01/29 Renewal|CEP granted|29/01/2025;
Notification|CEP granted|22/08/2024;
Monograph revision|Accepted - CEP remains valid|04/04/2022
2993 Nilotinib hydrochloride monohydrate SHANDONG LIXIN PHARMACEUTICAL CO. LTD. Zibo CN 100048250;100079839 CEP 2021-133 - Rev 01 2025/01/29 Valid 21/07/2028 Chemical 2025/01/29 Minor revision|CEP granted|29/01/2025;
New application|CEP granted|21/07/2023
3046 Pemetrexed disodium 2.5-hydrate SUZHOU LIXIN PHARMACEUTICAL CO., LTD. Suzhou CN 100012102;100019568 CEP 2021-072 - Rev 01 2025/01/29 Valid 08/07/2027 Chemical 2025/01/29 Minor revision|CEP granted|29/01/2025;
New application|CEP granted|08/07/2022
1751 Fosinopril sodium, Rhodium process ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Linhai CN 100011833;100018698 CEP 2024-433 - Rev 00 2025/01/29 Valid 29/01/2030 Chemical 2025/01/29 New application|CEP granted|29/01/2025

数据库说明:

当前数据更新日期:2025年12月06日。
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