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
1790 Naltrexone hydrochloride FRANCOPIA Paris FR 100041331;100098338 CEP 2009-287 - Rev 04 2025/10/20 Valid Chemical 2025/10/20 Notification|CEP granted|20/10/2025;
Notification|Accepted - CEP remains valid|24/02/2025;
Notification|CEP granted|01/03/2024;
Notification|CEP granted|02/05/2022;
Minor revision|Accepted - CEP remains valid|29/01/2021;
Minor revision|CEP granted|16/07/2020
622 Meclozine dihydrochloride JUBILANT BIOSYS LIMITED Nanjangud IN 100055198;100098088 CEP 2011-078 - Rev 03 2025/10/20 Valid Chemical 2025/10/20 Notification|CEP granted|20/10/2025;
Minor revision|Accepted - CEP remains valid|21/09/2022;
Notification|CEP granted|12/08/2022;
Major revision|CEP granted|13/07/2022
74 Codeine phosphate hemihydrate FRANCOPIA Paris FR 100041331;100098338 CEP 1997-118 - Rev 13 2025/10/20 Valid Chemical 2025/10/20 Notification|CEP granted|20/10/2025;
Minor revision|Accepted - CEP remains valid|11/09/2025;
Notification|CEP granted|01/03/2024;
Minor revision|CEP granted|27/02/2023;
Notification|CEP granted|02/05/2022;
Minor revision|Accepted - CEP remains valid|01/04/2022;
Minor revision|Accepted - CEP remains valid|24/09/2020
2372 Esomeprazole magnesium trihydrate JUBILANT BIOSYS LIMITED Nanjangud IN 100055198;100098088 CEP 2014-111 - Rev 03 2025/10/20 Valid Chemical 2025/10/20 Notification|CEP granted|20/10/2025;
Minor revision|CEP granted|26/04/2023;
Minor revision|Rejected|23/03/2023;
Notification|CEP granted|12/08/2022;
Renewal|CEP granted|14/12/2021
2258 Olanzapine, Form-II QILU PHARMACEUTICAL CO., LTD. Jinan CN 100014051;100061315 CEP 2012-191 - Rev 03 2025/10/20 Valid Chemical 2025/10/20 Minor revision|CEP granted|20/10/2025;
Minor revision|CEP granted|27/01/2025;
Notification|CEP granted|16/09/2021
1226 Imipenem monohydrate, Sterile, Synthetic origin SHANDONG ANHONG PHARMACEUTICAL CO., LTD. Dezhou CN 100014777;100050265 CEP 2024-396 - Rev 00 2025/10/20 Valid 20/10/2030 Chemical 2025/10/20 New application|CEP granted|20/10/2025
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
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

数据库说明:

当前数据更新日期:2026年02月10日。
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