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
1244 Morphine hemisulfate 2.5-hydrate FRANCOPIA Paris FR 100041331;100098338 CEP 2000-126 - Rev 08 2025/10/21 Valid Chemical 2025/10/21 Notification|CEP granted|21/10/2025;
Monograph revision|CEP granted|26/04/2024;
Notification|CEP granted|01/03/2024;
Notification|CEP granted|02/05/2022;
Notification|Accepted - CEP remains valid|20/02/2020
3078 Riociguat, Micronised and non-micronised MSN LIFE SCIENCES PRIVATE LIMITED Medak IN 100018316;100027671 CEP 2023-245 - Rev 00 2025/10/21 Valid 21/10/2030 Chemical 2025/10/21 New application|CEP granted|21/10/2025
1793 Oxycodone hydrochloride FRANCOPIA Paris FR 100041331;100098338 CEP 2008-249 - Rev 04 2025/10/20 Valid Chemical 2025/10/20 Notification|CEP granted|20/10/2025;
Minor revision|Accepted - CEP remains valid|19/04/2024;
Notification|CEP granted|01/03/2024;
Notification|CEP granted|02/05/2022;
Minor revision|Accepted - CEP remains valid|01/04/2020
97 Morphine hydrochloride trihydrate FRANCOPIA Paris FR 100041331;100098338 CEP 2008-208 - Rev 05 2025/10/20 Valid Chemical 2025/10/20 Notification|CEP granted|20/10/2025;
Monograph revision|CEP granted|25/04/2024;
Notification|CEP granted|01/03/2024;
Notification|Accepted - CEP remains valid|22/11/2023;
Transfer of holdership|CEP granted|25/05/2022
729 Naloxone hydrochloride dihydrate FRANCOPIA Paris FR 100041331;100098338 CEP 1996-050 - Rev 08 2025/10/20 Valid Chemical 2025/10/20 Notification|CEP granted|20/10/2025;
Notification|CEP granted|22/02/2024;
Major revision|Accepted - CEP remains valid|24/10/2023;
Notification|Accepted - CEP remains valid|06/02/2023;
Notification|CEP granted|02/05/2022;
Minor revision|Accepted - CEP remains valid|10/08/2020
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

数据库说明:

当前数据更新日期:2026年04月08日。
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