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
692 all-rac-alpha-Tocopherol DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 2019-164 - Rev 02 2025/10/22 Valid Chemical 2025/10/22 Renewal|CEP granted|22/10/2025;
Notification|CEP granted|11/07/2025
1745 Carvedilol MOEHS IBERICA S.L. Rubi ES 100029092;100068825 CEP 2002-089 - Rev 04 2025/10/22 Valid Chemical 2025/10/22 Minor revision|CEP granted|22/10/2025;
Minor revision|Accepted - CEP remains valid|28/02/2022;
Minor revision|Accepted - CEP remains valid|19/11/2021
681 Pancuronium bromide CURIA ITALY S.R.L. Rozzano, Milano IT 100032082;100050148 CEP 2005-120 - Rev 05 2025/10/22 Valid Chemical 2025/10/22 Minor revision|CEP granted|22/10/2025;
Notification|Accepted - CEP remains valid|14/12/2022;
Notification|CEP granted|05/08/2021;
Minor revision|CEP granted|20/07/2020
2606 Tadalafil SHANDONG CHENGHUI SHUANGDA PHARMACEUTICAL CO., LTD. Dezhou City CN 100048410;100080174 CEP 2025-131 - Rev 00 2025/10/22 Valid 22/10/2030 Chemical 2025/10/22 New application|CEP granted|22/10/2025
38 Levodopa, Enzymatic process ZHEJIANG WILD WIND PHARMACEUTICAL CO., LTD. Geshan Town CN 100024878;100034066 CEP 2021-195 - Rev 01 2025/10/22 Valid 12/10/2027 Chemical 2025/10/22 Minor revision|CEP granted|22/10/2025;
Minor revision|Accepted - CEP remains valid|23/04/2025;
Minor revision|Accepted - CEP remains valid|23/11/2022;
New application|CEP granted|12/10/2022
1998 Nicergoline SICHUAN RENAN PHARMACEUTICAL CO., LTD. Yuechi CN 100033464;100052360 CEP 2023-241 - Rev 00 2025/10/22 Valid 22/10/2030 Chemical 2025/10/22 New application|CEP granted|22/10/2025
2191 Atorvastatin calcium, Process II NINGBO MENOVO PHARMACEUTICAL CO., LTD. Ningbo CN 100030313;100047776 CEP 2024-120 - Rev 01 2025/10/22 Valid 18/09/2029 Chemical 2025/10/22 Monograph revision|CEP granted|22/10/2025;
New application|CEP granted|18/09/2024
2858 Mometasone furoate monohydrate, Crystalline Form, micronised NEWCHEM S.p.A. Milano IT 100017847;100080332 CEP 2024-348 - Rev 01 2025/10/22 Valid 17/10/2029 Chemical 2025/10/22 Minor revision|CEP granted|22/10/2025;
New application|CEP granted|17/10/2024
1705 Sertraline hydrochloride, Form I R.L. FINE CHEM PRIVATE LIMITED Chikkaballapur IN 100016723;100053383 CEP 2024-495 - Rev 00 2025/10/22 Valid 22/10/2030 Chemical 2025/10/22 New application|CEP granted|22/10/2025
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

数据库说明:

当前数据更新日期:2025年12月14日。
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