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
2131 Tamsulosin hydrochloride COHANCE LIFESCIENCES LIMITED Mumbai IN 100011755;100090273 CEP 2012-309 - Rev 03 2025/11/05 Valid Chemical 2025/11/05 Major revision|CEP granted|05/11/2025;
Notification|CEP granted|15/12/2022;
Minor revision|CEP granted|04/01/2022
2465 Irbesartan CTX LIFESCIENCES PVT. LIMITED Surat IN 100019102;100027863 CEP 2011-139 - Rev 07 2025/11/05 Valid Chemical 2025/11/05 Administrative procedure|CEP granted|05/11/2025;
Minor revision|CEP granted|24/10/2025;
Major revision|CEP granted|16/06/2023;
Minor revision|CEP granted|09/08/2021;
Minor revision|CEP granted|11/12/2020
549 Dexamethasone sodium phosphate, Process II TIANJIN TIANYAO PHARMACEUTICALS CO., LTD. Tianjin CN 100011805;100018616 CEP 2020-271 - Rev 01 2025/11/05 Valid 31/03/2027 Chemical and TSE 2025/11/05 Minor revision|CEP granted|05/11/2025;
New application|CEP granted|31/03/2022
2358 Teicoplanin DONGKOOK PHARMACEUTICAL CO., LTD. Seoul KR 100019576;100098744 CEP 2009-335 - Rev 05 2025/11/05 Valid Chemical 2025/11/05 Notification|CEP granted|05/11/2025;
Notification|CEP granted|19/10/2022;
Notification|Accepted - CEP remains valid|14/09/2020
354 Prednisone ZHEJIANG XIANJU PHARMACEUTICAL CO., LTD. Taizhou CN 100022759;100031459 CEP 2018-027 - Rev 03 2025/11/05 Valid Chemical 2025/11/05 Minor revision|CEP granted|05/11/2025;
Renewal|CEP granted|02/04/2024;
Minor revision|CEP granted|18/03/2022;
Notification|Accepted - CEP remains valid|06/08/2020
2422 Oseltamivir phosphate BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO., LTD. Suzhou CN 100011974;100021627 CEP 2022-488 - Rev 01 2025/11/05 Valid 07/03/2029 Chemical 2025/11/05 Minor revision|CEP granted|05/11/2025;
New application|CEP granted|07/03/2024
3052 Lercanidipine hydrochloride, Hemihydrate, Amorphous form HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2024-593 - Rev 00 2025/11/05 Valid 05/11/2030 Chemical 2025/11/05 New application|CEP granted|05/11/2025
2751 Valaciclovir hydrochloride hydrate ATUL BIOSCIENCE LIMITED Ambernath (East) IN 100044514;100086818 CEP 2024-401 - Rev 00 2025/11/03 Valid 03/11/2030 Chemical 2025/11/03 New application|CEP granted|03/11/2025
3132 Mirabegron SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN 100032307;100078783 CEP 2024-015 - Rev 00 2025/11/03 Valid 03/11/2030 Chemical 2025/11/03 New application|CEP granted|03/11/2025
2617 Aripiprazole JUBILANT BIOSYS LIMITED Nanjangud IN 100055198;100098088 CEP 2013-324 - Rev 02 2025/11/03 Valid Chemical 2025/11/03 Notification|CEP granted|03/11/2025;
Minor revision|Accepted - CEP remains valid|30/04/2024;
Notification|CEP granted|11/08/2022;
Notification|Accepted - CEP remains valid|13/12/2021;
Renewal|CEP granted|08/07/2021
1425 Fosfomycin trometamol LABIANA PHARMACEUTICALS, S.L.U. Corbera de Llobregat ES 100000356;100010380 CEP 2012-265 - Rev 06 2025/11/03 Valid Chemical 2025/11/03 Minor revision|CEP granted|03/11/2025;
Notification|Accepted - CEP remains valid|04/07/2025;
Notification|CEP granted|27/02/2024;
Administrative procedure|CEP granted|23/11/2023;
Notification|CEP granted|24/10/2023;
Notification|CEP granted|17/12/2021;
Minor revision|CEP granted|18/10/2021;
Minor revision|Accepted - CEP remains valid|07/04/2020
2591 Celecoxib, Micronised and non micronised KEKULE PHARMA LIMITED Hyderabad IN 100033239;100051871 CEP 2023-274 - Rev 00 2025/11/03 Valid 03/11/2030 Chemical 2025/11/03 New application|CEP granted|03/11/2025
1491 Amlodipine besilate, Micronised and non-micronised ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN 100011833;100018698 CEP 2016-282 - Rev 01 2025/11/03 Valid Chemical 2025/11/03 Major revision|CEP granted|03/11/2025;
Renewal|CEP granted|06/07/2023;
Minor revision|Accepted - CEP remains valid|13/07/2022;
Minor revision|Accepted - CEP remains valid|26/04/2021;
Minor revision|CEP granted|14/05/2020
. Bovine pericardial tissue BRIDGEMED SOLUTIONS, INC. Irvine US 100055072;100097778 CEP 2020-257 - Rev 01 2025/11/03 Valid TSE 2025/11/03 Renewal|CEP granted|03/11/2025;
New application|CEP granted|07/05/2021
1373 Testosterone JIANGSU JIAERKE PHARMACEUTICALS GROUP CO., LTD. Changzhou CN 100019383;100028149 CEP 2023-439 - Rev 00 2025/11/03 Valid 03/11/2030 Chemical 2025/11/03 New application|CEP granted|03/11/2025
1611 Diosmin, Process 2 BIORESINE INTERNATIONALE Kenitra MA 100015357;100092292 CEP 2024-565 - Rev 00 2025/11/03 Valid 03/11/2030 Chemical 2025/11/03 New application|CEP granted|03/11/2025
2357 Dydrogesterone, Micronised MANKIND PHARMA LIMITED New Delhi IN 100040218;100065486 CEP 2024-196 - Rev 00 2025/11/03 Valid 03/11/2030 Chemical 2025/11/03 New application|CEP granted|03/11/2025
2232 Losartan potassium, LB4 Process IPCA LABORATORIES LIMITED Mumbai IN 100011685;100018680 CEP 2019-224 - Rev 04 2025/11/03 Valid Chemical 2025/11/03 Renewal|CEP granted|03/11/2025;
Minor revision|Accepted - CEP remains valid|10/12/2024;
Minor revision|CEP granted|12/01/2023;
Administrative procedure|CEP granted|15/12/2021;
Major revision|CEP granted|03/12/2021;
Minor revision|Abandoned|30/09/2021
2849 Hydroxychloroquine sulfate WUHAN WUYAO PHARMACEUTICAL CO., LTD. Huangshi City CN 100022200;100030902 CEP 2023-088 - Rev 00 2025/11/03 Valid 03/11/2030 Chemical 2025/11/03 New application|CEP granted|03/11/2025
3115 Levocetirizine dihydrochloride, Process-2, Symed Labs Limited Unit-II, 2LCR SYMED LABS LIMITED Hyderabad IN 100018727;100090820 CEP 2025-384 - Rev 00 2025/11/03 Valid 03/11/2030 Chemical 2025/11/03 New application|CEP granted|03/11/2025

数据库说明:

当前数据更新日期:2025年12月08日。
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