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
1538 Lovastatin TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2000-406 - Rev 06 2025/07/08 Valid Chemical 2025/07/08 Administrative procedure|CEP granted|08/07/2025;
Minor revision|Accepted - CEP remains valid|09/05/2025;
Minor revision|Accepted - CEP remains valid|20/09/2022;
Notification|CEP granted|23/11/2021;
Monograph revision|CEP granted|09/08/2021;
Minor revision|Accepted - CEP remains valid|12/10/2020
533 Triamcinolone acetonide TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2009-084 - Rev 03 2025/07/08 Valid Chemical 2025/07/08 Notification|CEP granted|08/07/2025;
Notification|Accepted - CEP remains valid|05/08/2024;
Notification|Accepted - CEP remains valid|17/07/2023;
Minor revision|CEP granted|07/03/2022;
Minor revision|Accepted - CEP remains valid|31/03/2021
2640 Atomoxetine hydrochloride APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2014-241 - Rev 02 2025/07/08 Valid Chemical 2025/07/08 Minor revision|CEP granted|08/07/2025;
Notification|CEP granted|17/01/2024;
Renewal|CEP granted|21/01/2021
2372 Esomeprazole magnesium trihydrate LEE PHARMA LIMITED Hyderabad IN 100014849;100042625 CEP 2016-284 - Rev 01 2025/07/08 Valid Chemical 2025/07/08 Minor revision|CEP granted|08/07/2025;
Renewal|CEP granted|12/06/2023;
Major revision|CEP granted|16/01/2023
967 Acetylcysteine SEVEN STAR PHARMACEUTICAL COMPANY, LTD. New Taipei City TW 100024386;100033558 CEP 2022-177 - Rev 02 2025/07/08 Valid 29/08/2028 Chemical 2025/07/08 Major revision|CEP granted|08/07/2025;
Minor revision|CEP granted|01/08/2024;
New application|CEP granted|29/08/2023
2191 Atorvastatin calcium NINGBO MENOVO PHARMACEUTICAL CO., LTD. Ningbo CN 100030313;100047776 CEP 2019-013 - Rev 01 2025/07/08 Valid Chemical 2025/07/08 Renewal|CEP granted|08/07/2025;
Monograph revision|Accepted - CEP remains valid|19/07/2022
681 Pancuronium bromide TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2009-391 - Rev 03 2025/07/08 Valid Chemical 2025/07/08 Notification|CEP granted|08/07/2025;
Notification|Accepted - CEP remains valid|30/01/2023;
Notification|CEP granted|05/01/2022;
Minor revision|CEP granted|07/05/2020
2781 Tolterodine tartrate FLEMING LABORATORIES LIMITED Hyderabad IN 100015641;100067279 CEP 2022-455 - Rev 00 2025/07/08 Valid 08/07/2030 Chemical 2025/07/08 New application|Abandoned|08/07/2025
1653 Potassium clavulanate, diluted, with silica, colloidal hydrated in the ratio 1:1 SHANXI SHUANGYAN PHARMACEUTICAL CO., LTD. Datong CN 100052070;100091614 CEP 2024-531 - Rev 00 2025/07/08 Valid 08/07/2030 Chemical 2025/07/08 New application|CEP granted|08/07/2025
1653 Potassium clavulanate, diluted, with microcrystalline cellulose in the ratio 1:1 SHANXI SHUANGYAN PHARMACEUTICAL CO., LTD. Datong CN 100052070;100091614 CEP 2024-543 - Rev 00 2025/07/08 Valid 08/07/2030 Chemical 2025/07/08 New application|CEP granted|08/07/2025
2280 Fexofenadine hydrochloride, Form I (FXA4) DR. REDDY'S LABORATORIES LIMITED Hyderabad IN 100003991;100000217 CEP 2025-159 - Rev 00 2025/07/08 Valid 08/07/2030 Chemical 2025/07/08 New application|CEP granted|08/07/2025
1590 Epirubicin hydrochloride, Lyophilised TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2003-140 - Rev 03 2025/07/07 Valid Chemical 2025/07/07 Notification|CEP granted|07/07/2025;
Notification|CEP granted|23/02/2022
1322 Fenofibrate HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2012-290 - Rev 02 2025/07/07 Valid Chemical 2025/07/07 Minor revision|CEP granted|07/07/2025;
Minor revision|CEP granted|22/06/2021
1050 Ticlopidine hydrochloride TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2001-379 - Rev 06 2025/07/07 Valid Chemical 2025/07/07 Notification|CEP granted|07/07/2025;
Notification|CEP granted|04/01/2022
1590 Epirubicin hydrochloride TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2008-040 - Rev 06 2025/07/07 Valid Chemical 2026/03/17 Minor revision|Accepted - CEP remains valid|17/03/2026;
Notification|CEP granted|07/07/2025;
Notification|CEP granted|03/09/2024;
Minor revision|CEP granted|05/06/2024;
Notification|Accepted - CEP remains valid|06/06/2023;
Minor revision|CEP granted|01/02/2022
312 Betamethasone TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2010-365 - Rev 03 2025/07/07 Valid Chemical 2025/11/26 Major revision|Rejected|26/11/2025;
Minor revision|CEP granted|07/07/2025;
Notification|CEP granted|29/05/2024;
Notification|CEP granted|22/11/2021;
Minor revision|Accepted - CEP remains valid|29/09/2021
2443 Fulvestrant TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2013-255 - Rev 03 2025/07/07 Valid Chemical 2025/07/07 Notification|CEP granted|07/07/2025;
Minor revision|CEP granted|21/08/2023;
Notification|CEP granted|10/11/2021
3014 Rotigotine Interquim, S.A. Sant Cugat Del Vallès ES 100011698;100021071 CEP 2019-302 - Rev 02 2025/07/07 Valid 28/05/2026 Chemical 2025/07/07 Minor revision|CEP granted|07/07/2025;
Minor revision|CEP granted|03/05/2024;
Minor revision|Accepted - CEP remains valid|18/02/2022;
Notification|Rejected|08/12/2021
2606 Tadalafil UNICHEM LABORATORIES LIMITED Mumbai IN 100005397;100093080 CEP 2015-132 - Rev 01 2025/07/07 Valid Chemical 2025/07/07 Major revision|CEP granted|07/07/2025;
Renewal|CEP granted|07/07/2021
2857 Trazodone hydrochloride MSN LIFE SCIENCES PRIVATE LIMITED Medak IN 100018316;100027671 CEP 2024-089 - Rev 00 2025/07/07 Valid 07/07/2030 Chemical 2025/07/07 New application|CEP granted|07/07/2025

数据库说明:

当前数据更新日期:2026年04月06日。
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