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
2777 Pregabalin AALIDHRA PHARMACHEM PRIVATE LIMITED Nandesari IN 100042480;100070177 R0-CEP 2019-085 - Rev 02 2023/03/07 Valid 15/09/2025 Chemical 2023/03/07 Minor revision|CEP granted|07/03/2023;
Minor revision|CEP granted|08/03/2022
2768 Fluticasone furoate, Process 1 CORAL DRUGS PRIVATE LIMITED New Delhi IN 100019182;100042823 R0-CEP 2021-372 - Rev 00 2023/03/07 Valid 07/03/2028 Chemical 2023/03/07 New application|CEP granted|07/03/2023
2858 Mometasone furoate monohydrate TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL 100000702;100060842 R0-CEP 2022-287 - Rev 01 2023/03/07 Valid 20/02/2028 Chemical 2023/03/07 Administrative procedure|CEP granted|07/03/2023;
New application|CEP granted|20/02/2023
2787 Esomeprazole magnesium dihydrate HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 R1-CEP 2014-333 - Rev 01 2023/03/07 Valid Chemical 2023/03/07 Notification|CEP granted|07/03/2023;
Renewal|CEP granted|26/04/2022;
Minor revision|CEP granted|11/03/2020
2616 Topiramate HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 R0-CEP 2020-130 - Rev 01 2023/03/06 Valid 13/07/2027 Chemical 2023/03/06 Notification|CEP granted|06/03/2023;
New application|CEP granted|13/07/2022
2932 Rivaroxaban CIPLA LIMITED Mumbai IN 100006004;100018147 R0-CEP 2021-278 - Rev 00 2023/03/06 Valid 06/03/2028 Chemical 2023/03/06 New application|CEP granted|06/03/2023
2768 Fluticasone furoate CORAL DRUGS PRIVATE LIMITED New Delhi IN 100019182;100042823 R0-CEP 2022-018 - Rev 00 2023/03/06 Valid 06/03/2028 Chemical 2023/03/06 New application|CEP granted|06/03/2023
714 Doxorubicin Hydrochloride TRANSO-PHARM HANDELS GMBH Siek DE 100018331;100027110 R1-CEP 2004-059 - Rev 03 2023/03/06 Valid Chemical 2023/03/06 Notification|CEP granted|06/03/2023;
Notification|Rejected|09/11/2022
550 Diazoxide MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN 100011732;100018657 R0-CEP 2021-065 - Rev 00 2023/03/03 Valid 03/03/2028 Chemical 2023/03/03 New application|CEP granted|03/03/2023
1755 Ketorolac trometamol VASUDHA PHARMA CHEM LIMITED Hyderabad IN 100011811;100018603 R1-CEP 2014-369 - Rev 01 2023/03/03 Valid Chemical 2023/03/03 Minor revision|CEP granted|03/03/2023;
Renewal|CEP granted|02/02/2022
391 Furosemide MANGALAM DRUGS & ORGANICS LTD. Mumbai IN R0-CEP 2019-063 - Rev 01 2023/03/02 Valid 07/09/2026 Chemical 2023/03/02 Major revision|CEP granted|02/03/2023
2445 Adapalene BAL PHARMA LIMITED Bangalore IN 100016398;100041736 R1-CEP 2016-309 - Rev 00 2023/03/02 Valid Chemical 2023/03/02 Renewal|CEP granted|02/03/2023
1829 Horse-chestnut dry extract, standardised, DER 4-6:1 SCHWABE EXTRACTA GMBH & CO. KG Karlsruhe DE 100021578;100030272 R1-CEP 2017-086 - Rev 00 2023/03/02 Valid Herbal 2024/03/21 Notification|Accepted - CEP remains valid|21/03/2024;
Monograph revision|Accepted - CEP remains valid|28/08/2023;
Renewal|CEP granted|02/03/2023;
Minor revision|Accepted - CEP remains valid|09/11/2021;
Minor revision|CEP granted|30/04/2020
1765 Salmeterol xinafoate, Process I HOVIONE FARMACIENCIA S.A. Loures PT 100001467;100000315 R1-CEP 2017-055 - Rev 01 2023/03/01 Valid Chemical 2023/03/01 Minor revision|CEP granted|01/03/2023;
Renewal|CEP granted|19/09/2022
513 Miconazole nitrate JANSSEN PHARMACEUTICA NV Beerse BE 100000625;100005958 R2-CEP 1995-008 - Rev 04 2023/03/01 Valid Chemical 2023/09/21 Notification|Accepted - CEP remains valid|21/09/2023;
Administrative procedure|CEP granted|01/03/2023;
Minor revision|CEP granted|09/12/2022
1368 Ramipril, RMP EGIS Pharmaceuticals PLC Budapest HU 100001091;100001662 R0-CEP 2020-284 - Rev 01 2023/02/28 Valid 19/03/2026 Chemical 2023/02/28 Notification|CEP granted|28/02/2023;
New application|CEP granted|19/03/2021
2306 Gemcitabine hydrochloride, GA process HETERO LABS LIMITED Hyderabad IN 100011681;100018664 R0-CEP 2022-499 - Rev 00 2023/02/28 Valid 28/02/2028 Chemical 2023/02/28 New application|CEP granted|28/02/2023
2306 Gemcitabine hydrochloride JIANGSU HANSOH PHARMACEUTICAL GROUP CO., LTD. Lianyungang City CN R1-CEP 2017-076 - Rev 00 2023/02/28 Valid Chemical 2023/02/28 Renewal|CEP granted|28/02/2023
2606 Tadalafil, Process II MYLAN LABORATORIES LIMITED Hyderabad IN 100011537;100018667 R0-CEP 2019-201 - Rev 01 2023/02/27 Valid 20/12/2024 Chemical 2023/02/27 Minor revision|CEP granted|27/02/2023
662 Daunorubicin Hydrochloride DZD (HEZE) PHARMACEUTICAL CO., LTD. Heze City CN 100039412;100062056 R1-CEP 2016-253 - Rev 01 2023/02/27 Valid Chemical 2023/02/27 Monograph revision|CEP granted|27/02/2023;
Renewal|CEP granted|19/10/2022

数据库说明:

当前数据更新日期:2024年05月04日。
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