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
2932 Rivaroxaban, Form I NEULAND LABORATORIES LIMITED Hyderabad IN 100011545;100062134 CEP 2021-045 - Rev 01 2025/03/14 Valid 23/06/2028 Chemical 2025/03/14 Minor revision|CEP granted|14/03/2025;
Minor revision|Accepted - CEP remains valid|20/10/2023;
New application|CEP granted|23/06/2023
922 Ketoprofen, Process II SCL LIFESCIENCES LIMITED Sahibzada Ajit Singh Nagar IN 100011774;100018647 CEP 2024-496 - Rev 01 2025/03/14 Valid 10/01/2030 Chemical 2025/03/14 Notification|CEP granted|14/03/2025;
New application|CEP granted|10/01/2025
330 Gelatin, Pig hide gelatin, partial alkaline hydrolysis, bloom value 220 g WEIHAI YINHE BIOLOGICAL TECHNOLOGY CO., LTD. Weihai CN 100050003;100087303 CEP 2024-374 - Rev 00 2025/03/14 Valid 14/03/2030 Chemical 2025/03/14 New application|CEP granted|14/03/2025
922 Ketoprofen SCL LIFESCIENCES LIMITED Sahibzada Ajit Singh Nagar IN 100011774;100018647 CEP 2021-457 - Rev 02 2025/03/14 Valid 05/12/2028 Chemical 2025/03/14 Notification|CEP granted|14/03/2025;
Monograph revision|CEP granted|15/11/2024;
New application|CEP granted|05/12/2023
2127 Clobetasol propionate, Micronised TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2007-066 - Rev 06 2025/03/12 Valid Chemical 2025/03/12 Notification|CEP granted|12/03/2025;
Notification|Accepted - CEP remains valid|05/09/2023;
Minor revision|CEP granted|18/05/2022;
Notification|CEP granted|04/01/2022;
Notification|Accepted - CEP remains valid|02/03/2021;
Monograph revision|CEP granted|20/05/2020
1350 Nabumetone TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2000-115 - Rev 13 2025/03/12 Valid Chemical 2025/09/03 Minor revision|Accepted - CEP remains valid|03/09/2025;
Notification|CEP granted|12/03/2025;
Minor revision|CEP granted|02/08/2024;
Notification|Accepted - CEP remains valid|17/03/2023;
Notification|CEP granted|07/03/2022;
Minor revision|CEP granted|14/06/2021
29 Imipramine hydrochloride TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2002-051 - Rev 05 2025/03/12 Valid Chemical 2025/03/12 Notification|CEP granted|12/03/2025;
Minor revision|CEP granted|30/01/2024;
Minor revision|CEP granted|24/02/2022;
Notification|Accepted - CEP remains valid|14/12/2020
2333 Fluvastatin sodium TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2010-201 - Rev 03 2025/03/12 Valid Chemical 2025/03/12 Notification|CEP granted|12/03/2025;
Major revision|CEP granted|05/05/2023;
Notification|CEP granted|04/02/2022
2465 Irbesartan TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2011-251 - Rev 07 2025/03/12 Valid Chemical 2025/07/24 Notification|Accepted - CEP remains valid|24/07/2025;
Notification|CEP granted|12/03/2025;
Major revision|CEP granted|16/12/2024;
Notification|CEP granted|17/06/2024;
Minor revision|Accepted - CEP remains valid|17/02/2023;
Minor revision|CEP granted|30/09/2021;
Notification|CEP granted|03/03/2021;
Major revision|CEP granted|30/07/2020
2465 Irbesartan TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2010-322 - Rev 03 2025/03/12 Valid Chemical 2025/03/12 Notification|CEP granted|12/03/2025;
Notification|CEP granted|07/03/2022
2583 Montelukast sodium, ID 6177 TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2017-131 - Rev 06 2025/03/12 Valid Chemical 2025/08/05 Notification|Accepted - CEP remains valid|05/08/2025;
Notification|CEP granted|12/03/2025;
Major revision|CEP granted|27/09/2024;
Renewal|CEP granted|19/03/2024;
Notification|CEP granted|23/03/2023;
Minor revision|CEP granted|08/11/2021
2531 Clopidogrel hydrogen sulfate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2011-143 - Rev 04 2025/03/12 Valid Chemical 2025/03/12 Notification|CEP granted|12/03/2025;
Notification|Accepted - CEP remains valid|10/07/2023;
Notification|CEP granted|08/02/2022;
Notification|CEP granted|30/06/2021;
Minor revision|CEP granted|28/04/2020
2600 Olmesartan medoxomil, Process 2 TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2020-325 - Rev 02 2025/03/12 Valid Chemical 2025/11/24 Renewal|Accepted - CEP remains valid|24/11/2025;
Notification|CEP granted|12/03/2025;
Notification|Accepted - CEP remains valid|17/01/2024;
Notification|CEP granted|23/02/2022;
New application|CEP granted|06/01/2021
2232 Losartan potassium, Process 2 TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2021-227 - Rev 02 2025/03/12 Valid 17/11/2027 Chemical 2025/03/12 Notification|CEP granted|12/03/2025;
Notification|CEP granted|13/02/2023;
New application|CEP granted|17/11/2022
2465 Irbesartan, Process 2 TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2022-046 - Rev 02 2025/03/12 Valid 20/10/2027 Chemical 2025/03/12 Notification|CEP granted|12/03/2025;
Notification|CEP granted|04/03/2024;
New application|CEP granted|20/10/2022
896 Deferoxamine mesilate, Produced by a synthetic process EXCELLA GMBH & CO. KG Feucht DE 100012030;100020739 CEP 2009-401 - Rev 06 2025/03/11 Valid Chemical 2025/03/11 Minor revision|CEP granted|11/03/2025;
Minor revision|CEP granted|25/10/2024;
Minor revision|CEP granted|16/03/2023
1046 Tamoxifen citrate, Milled A; Milled Z EXCELLA GMBH & CO. KG Feucht DE 100012030;100020739 CEP 2021-495 - Rev 03 2025/03/11 Valid 13/03/2028 Chemical 2025/03/11 Minor revision|CEP granted|11/03/2025;
Notification|CEP granted|28/10/2024;
Major revision|CEP granted|06/07/2023;
New application|CEP granted|13/03/2023
1331 Glyceryl trinitrate solution Dynamit Nobel GmbH, Explosivstoff- und Systemtechnik Leverkusen DE 100011675;100020630 CEP 2003-185 - Rev 02 2025/03/11 Valid Chemical 2025/03/11 Major revision|CEP granted|11/03/2025
464 Amitriptyline hydrochloride TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2001-432 - Rev 06 2025/03/11 Valid Chemical 2025/03/11 Notification|CEP granted|11/03/2025;
Minor revision|CEP granted|07/05/2024;
Notification|Accepted - CEP remains valid|05/07/2023;
Notification|Accepted - CEP remains valid|02/08/2022;
Notification|CEP granted|04/02/2022;
Minor revision|Accepted - CEP remains valid|12/10/2021;
Notification|Rejected|16/08/2021
994 Ciclosporin TAPI CZECH INDUSTRIES S.R.O. Opava CZ 100051642;100090678 CEP 2002-152 - Rev 07 2025/03/11 Valid Chemical 2025/03/11 Notification|CEP granted|11/03/2025;
Minor revision|CEP granted|21/06/2023;
Monograph revision|CEP granted|02/09/2021;
Minor revision|Accepted - CEP remains valid|24/02/2020

数据库说明:

当前数据更新日期:2026年02月03日。
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