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
2630 Rivastigmine hydrogen tartrate MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2013-003 - Rev 04 2025/09/25 Valid Chemical 2025/09/25 Notification|CEP granted|25/09/2025;
Notification|CEP granted|30/07/2024;
Notification|CEP granted|28/09/2021;
Minor revision|CEP granted|24/06/2021
330 Gelatin, Caustic and lime hide gelatin GELITA AG Eberbach DE 100012955;100080863 CEP 2021-504 - Rev 01 2025/09/25 Valid 02/06/2027 TSE 2025/09/25 Transfer of holdership|CEP granted|25/09/2025;
New application|CEP granted|02/06/2022
2606 Tadalafil MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2012-021 - Rev 04 2025/09/25 Valid Chemical 2025/09/25 Notification|CEP granted|25/09/2025;
Notification|CEP granted|31/07/2024
930 Lysine Hydrochloride SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN 100025187;100034386 CEP 2012-007 - Rev 01 2025/09/25 Valid Chemical 2025/09/25 Minor revision|CEP granted|25/09/2025;
Notification|Accepted - CEP remains valid|07/05/2024;
Minor revision|Accepted - CEP remains valid|11/08/2023;
Notification|Accepted - CEP remains valid|11/02/2022;
Minor revision|Accepted - CEP remains valid|16/12/2021
312 Betamethasone, Micronised MSD EUROPE BELGIUM Watermael-Boitsfort BE 100049238;100083482 CEP 2012-214 - Rev 01 2025/09/25 Valid Chemical 2025/09/25 Minor revision|CEP granted|25/09/2025
1765 Salmeterol xinafoate MELODY HEALTHCARE PRIVATE LIMITED Mumbai IN 100014822;100073679 CEP 2010-097 - Rev 02 2025/09/25 Valid Chemical 2025/09/25 Minor revision|CEP granted|25/09/2025;
Minor revision|Accepted - CEP remains valid|27/11/2020;
Notification|Rejected|06/10/2020
873 Amidotrizoic Acid Dihydrate JUSTESA IMAGEN, S.A.U. Coslada ES 100000769;100004566 CEP 1999-181 - Rev 04 2025/09/25 Valid Chemical 2025/09/25 Minor revision|CEP granted|25/09/2025;
Minor revision|Accepted - CEP remains valid|31/10/2024
2629 Rivastigmine MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2012-304 - Rev 03 2025/09/25 Valid Chemical 2025/09/25 Notification|CEP granted|25/09/2025;
Notification|CEP granted|30/07/2024;
Notification|CEP granted|28/09/2021
921 Ketoconazole DERIVADOS QUIMICOS S.A. Alcantarilla ES 100011657;100020423 CEP 2016-102 - Rev 04 2025/09/25 Valid Chemical 2025/09/25 Minor revision|CEP granted|25/09/2025;
Renewal|CEP granted|23/10/2023;
Minor revision|Accepted - CEP remains valid|26/08/2022;
Monograph revision|CEP granted|23/04/2021
664 Dopamine hydrochloride WUHAN WUYAO PHARMACEUTICAL CO., LTD. Huangshi City CN 100022200;100030902 CEP 2023-178 - Rev 00 2025/09/25 Valid 25/09/2030 Chemical 2025/09/25 New application|CEP granted|25/09/2025
1699 Mesalazine, Mesalazine (MZ4B Process) IPCA LABORATORIES LIMITED Mumbai IN 100011685;100018680 CEP 2020-381 - Rev 01 2025/09/25 Valid Chemical 2025/11/26 Renewal|Accepted - CEP remains valid|26/11/2025;
Major revision|CEP granted|25/09/2025;
Minor revision|Accepted - CEP remains valid|19/09/2024;
Notification|Accepted - CEP remains valid|26/06/2023;
New application|CEP granted|15/03/2021
3132 Mirabegron, Alpha form PIRAMAL PHARMA LIMITED Digwal Village IN 100036948;100058375 CEP 2024-093 - Rev 00 2025/09/25 Valid 25/09/2030 Chemical 2025/09/25 New application|CEP granted|25/09/2025
651 Amiloride hydrochloride dihydrate BAL PHARMA LIMITED Bengaluru IN 100016398;100041736 CEP 2022-337 - Rev 00 2025/09/25 Valid 25/09/2030 Chemical 2025/09/25 New application|CEP granted|25/09/2025
1451 Mupirocin calcium, Process B FUJIAN COMHONY BIOTECHNOLOGY CO., LTD. Fuqing CN 100043888;100072481 CEP 2022-501 - Rev 01 2025/09/25 Valid 28/03/2029 Chemical and TSE 2025/09/25 Minor revision|CEP granted|25/09/2025;
New application|CEP granted|28/03/2024
2307 Modafinil MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2008-199 - Rev 05 2025/09/24 Valid Chemical 2025/09/24 Notification|CEP granted|24/09/2025;
Notification|CEP granted|01/08/2024
2617 Aripiprazole MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2013-330 - Rev 03 2025/09/24 Valid Chemical 2025/09/24 Notification|CEP granted|24/09/2025;
Notification|CEP granted|29/07/2024;
Monograph revision|CEP granted|02/09/2021;
Renewal|CEP granted|30/04/2020
2338 Mirtazapine MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2008-205 - Rev 07 2025/09/24 Valid Chemical 2025/09/24 Notification|CEP granted|24/09/2025;
Notification|CEP granted|30/07/2024;
Minor revision|CEP granted|06/04/2022
2303 Adrenaline MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2015-006 - Rev 02 2025/09/24 Valid Chemical 2025/09/24 Notification|CEP granted|24/09/2025;
Notification|CEP granted|29/07/2024;
Monograph revision|Accepted - CEP remains valid|30/01/2023;
Renewal|CEP granted|30/11/2021
599 Cisplatin QILU PHARMACEUTICAL CO., LTD. Jinan CN 100014051;100061315 CEP 2010-122 - Rev 03 2025/09/24 Valid Chemical 2025/09/24 Notification|CEP granted|24/09/2025;
Minor revision|Accepted - CEP remains valid|06/06/2025;
Minor revision|Accepted - CEP remains valid|16/06/2022;
Notification|Accepted - CEP remains valid|28/01/2022;
Notification|CEP granted|16/09/2021;
Notification|Accepted - CEP remains valid|24/04/2020
2119 Venlafaxine hydrochloride MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2006-236 - Rev 06 2025/09/24 Valid Chemical 2025/09/24 Notification|CEP granted|24/09/2025;
Notification|CEP granted|31/07/2024

数据库说明:

当前数据更新日期:2025年12月20日。
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