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
2779 Solifenacin succinate JUBILANT BIOSYS LIMITED Nanjangud IN 100055198;100098088 CEP 2016-080 - Rev 02 2025/10/20 Valid Chemical 2025/10/20 Notification|CEP granted|20/10/2025;
Notification|CEP granted|11/08/2022;
Renewal|CEP granted|20/12/2021
76 Codeine monohydrate FRANCOPIA Paris FR 100041331;100098338 CEP 2014-143 - Rev 03 2025/10/20 Valid Chemical 2025/11/19 Minor revision|Accepted - CEP remains valid|19/11/2025;
Notification|CEP granted|20/10/2025;
Notification|CEP granted|01/03/2024;
Notification|CEP granted|02/05/2022;
Notification|Accepted - CEP remains valid|01/09/2021;
Notification|Rejected|05/08/2021;
Renewal|CEP granted|26/06/2020
491 Ethylmorphine Hydrochloride FRANCOPIA Paris FR 100041331;100098338 CEP 2012-128 - Rev 03 2025/10/20 Valid Chemical 2025/10/20 Notification|CEP granted|20/10/2025;
Notification|CEP granted|01/03/2024;
Notification|Accepted - CEP remains valid|17/07/2023;
Notification|CEP granted|02/05/2022
821 Estradiol hemihydrate, Dorog site GEDEON RICHTER PLC. Budapest HU 100000640;100001653 CEP 2025-255 - Rev 00 2025/10/20 Valid 20/10/2030 Chemical 2025/10/20 New application|CEP granted|20/10/2025
2406 Anastrozole, Form-II HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2013-172 - Rev 02 2025/10/17 Valid Chemical 2025/10/17 Minor revision|CEP granted|17/10/2025;
Minor revision|Accepted - CEP remains valid|13/07/2023;
Notification|Rejected|23/01/2023;
Minor revision|CEP granted|15/12/2020
1649 Azithromycin, Monohydrate JUBILANT BIOSYS LIMITED Nanjangud IN 100055198;100098088 CEP 2007-118 - Rev 06 2025/10/17 Valid Chemical 2025/10/17 Notification|CEP granted|17/10/2025;
Notification|CEP granted|12/08/2022;
Monograph revision|CEP granted|14/01/2022
2465 Irbesartan JUBILANT BIOSYS LIMITED Nanjangud IN 100055198;100098088 CEP 2011-087 - Rev 05 2025/10/17 Valid Chemical 2025/10/17 Notification|CEP granted|17/10/2025;
Minor revision|CEP granted|25/03/2024;
Minor revision|CEP granted|23/10/2023;
Notification|CEP granted|11/08/2022;
Monograph revision|Accepted - CEP remains valid|28/07/2022
543 Carbamazepine, CMZ JUBILANT BIOSYS LIMITED Nanjangud IN 100055198;100098088 CEP 2011-206 - Rev 02 2025/10/17 Valid Chemical 2025/10/17 Notification|CEP granted|17/10/2025;
Notification|CEP granted|24/08/2022
2572 Risedronate sodium 2.5-hydrate JUBILANT BIOSYS LIMITED Nanjangud IN 100055198;100098088 CEP 2014-010 - Rev 02 2025/10/17 Valid Chemical 2025/10/17 Notification|CEP granted|17/10/2025;
Monograph revision|Accepted - CEP remains valid|05/10/2023;
Notification|CEP granted|23/08/2022
543 Carbamazepine JUBILANT BIOSYS LIMITED Nanjangud IN 100055198;100098088 CEP 1999-109 - Rev 07 2025/10/17 Valid Chemical 2025/10/17 Notification|CEP granted|17/10/2025;
Notification|CEP granted|23/08/2022
2372 Esomeprazole magnesium trihydrate, Powder JUBILANT BIOSYS LIMITED Nanjangud IN 100055198;100098088 CEP 2023-175 - Rev 02 2025/10/17 Valid 18/08/2028 Chemical 2025/10/17 Notification|CEP granted|17/10/2025;
Administrative procedure|CEP granted|23/08/2023;
New application|CEP granted|18/08/2023
2766 Exemestane, Micronised SYNTHON B.V. Nijmegen NL 100001342;100005475 CEP 2022-424 - Rev 02 2025/10/17 Valid 06/10/2028 Chemical 2025/10/17 Notification|CEP granted|17/10/2025;
Minor revision|CEP granted|02/09/2024;
New application|CEP granted|06/10/2023
1563 Simvastatin, Ethanol II process TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2019-179 - Rev 02 2025/10/17 Valid Chemical 2025/10/17 Renewal|CEP granted|17/10/2025;
Notification|CEP granted|20/12/2021
577 Amoxicillin sodium, Sterile, Enzymatic route SANDOZ GMBH Kundl AT 100000546;100000450 CEP 2025-064 - Rev 01 2025/10/17 Valid 28/03/2030 Chemical 2025/10/17 Notification|CEP granted|17/10/2025;
New application|CEP granted|28/03/2025
543 Carbamazepine, Carbamazepine CBA Powder JUBILANT BIOSYS LIMITED Nanjangud IN 100055198;100098088 CEP 2024-439 - Rev 01 2025/10/17 Valid 05/03/2030 Chemical 2025/10/17 Notification|CEP granted|17/10/2025;
New application|CEP granted|05/03/2025
2733 Escitalopram oxalate JUBILANT BIOSYS LIMITED Nanjangud IN 100055198;100098088 CEP 2017-082 - Rev 01 2025/10/17 Valid Chemical 2025/10/17 Notification|CEP granted|17/10/2025;
Renewal|CEP granted|09/06/2023;
Notification|CEP granted|12/08/2022
1363 Prilocaine Hydrochloride MOEHS IBERICA S.L. Rubi ES 100029092;100068825 CEP 2025-153 - Rev 00 2025/10/17 Valid 17/10/2030 Chemical 2025/10/17 New application|CEP granted|17/10/2025
2631 Rosuvastatin calcium, Process-II AMOLI ORGANICS PRIVATE LIMITED Mumbai IN 100016500;100025303 CEP 2025-379 - Rev 00 2025/10/16 Valid 16/10/2030 Chemical 2025/10/16 New application|CEP granted|16/10/2025
3049 Etonogestrel CURIA SPAIN S.A.U. Boecillo ES 100011649;100019586 CEP 2025-093 - Rev 01 2025/10/16 Valid 19/09/2030 Chemical 2025/10/16 Notification|CEP granted|16/10/2025;
New application|CEP granted|19/09/2025
1564 Sodium alendronate trihydrate IPCA LABORATORIES LIMITED Mumbai IN 100011685;100018680 CEP 2008-090 - Rev 03 2025/10/16 Valid Chemical 2025/10/16 Minor revision|CEP granted|16/10/2025;
Notification|Accepted - CEP remains valid|23/06/2023;
Minor revision|CEP granted|27/04/2021

数据库说明:

当前数据更新日期:2025年12月14日。
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