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
333 Heparin sodium, For parenteral preparations NANJING KING-FRIEND BIOCHEMICAL PHARMACEUTICAL CO., LTD. Nanjing CN 100021124;100054143 CEP 2005-070 - Rev 11 2025/02/05 Valid Chemical 2025/12/04 Monograph revision|Accepted - CEP remains valid|04/12/2025;
Notification|CEP granted|05/02/2025;
Monograph revision|Accepted - CEP remains valid|09/12/2024;
Notification|CEP granted|20/02/2024;
Minor revision|CEP granted|08/06/2023;
Notification|CEP granted|05/12/2022;
Notification|CEP granted|13/12/2021;
Minor revision|CEP granted|05/01/2021
1423 Flutamide FERMION OY Espoo FI 100011508;100020280 CEP 2002-134 - Rev 05 2025/02/05 Valid Chemical 2025/02/05 Administrative procedure|CEP granted|05/02/2025;
Minor revision|CEP granted|22/01/2025;
Minor revision|Accepted - CEP remains valid|03/12/2021
1075 Budesonide, Codes 201680 and 2016112 STERLING S.p.A. Solomeo Di Corciano IT 100024377;100033551 CEP 2017-138 - Rev 04 2025/02/05 Valid Chemical 2025/02/05 Major revision|CEP granted|05/02/2025;
Renewal|CEP granted|15/02/2024;
Major revision|Abandoned|02/11/2023
817 Cyproheptadine hydrochloride 1.5-hydrate OLON S.P.A. Rodano IT 100012085;100019537 CEP 2014-049 - Rev 02 2025/02/05 Valid Chemical 2025/02/05 Minor revision|CEP granted|05/02/2025;
Minor revision|CEP granted|25/01/2022;
Renewal|CEP granted|09/07/2021;
Minor revision|CEP granted|28/01/2021
1132 Methylthioninium chloride hydrate ICROM S.R.L. Concorezzo IT 100022464;100031145 CEP 2022-296 - Rev 01 2025/02/05 Valid 18/12/2028 Chemical 2025/02/05 Minor revision|CEP granted|05/02/2025;
New application|CEP granted|18/12/2023
2600 Olmesartan medoxomil MACLEODS PHARMACEUTICALS LIMITED Mumbai IN 100021441;100077265 CEP 2014-196 - Rev 02 2025/02/04 Valid Chemical 2025/02/04 Major revision|CEP granted|04/02/2025;
Minor revision|CEP granted|13/03/2023;
Renewal|CEP granted|07/04/2022;
Minor revision|CEP granted|09/08/2021;
Minor revision|CEP granted|27/01/2021;
Minor revision|CEP granted|06/08/2020
429 Progesterone, Process B, non-micronised and micronised HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO., LTD. Ezhou City CN 100015482;100024200 CEP 2018-166 - Rev 04 2025/02/04 Valid Chemical 2025/02/04 Renewal|CEP granted|04/02/2025;
Minor revision|CEP granted|20/08/2024;
Minor revision|CEP granted|09/04/2024;
Notification|CEP granted|19/01/2024
2331 Rabeprazole sodium hydrate KRKA, d.d., Novo mesto Novo mesto SI 100000627;100009540 CEP 2018-140 - Rev 02 2025/02/04 Valid Chemical 2025/02/04 Renewal|CEP granted|04/02/2025;
Minor revision|CEP granted|17/10/2022
272 Doxycycline hyclate YANGZHOU LIBERTY PHARMACEUTICAL CO., LTD. Yangzhou CN 100023496;100032638 CEP 2000-165 - Rev 08 2025/02/04 Valid Chemical 2025/02/04 Notification|CEP granted|04/02/2025;
Notification|Accepted - CEP remains valid|17/07/2023;
Minor revision|CEP granted|20/04/2022
2591 Celecoxib, Process II JIANGXI SYNERGY PHARMACEUTICAL CO., LTD. Yichun CN 100020812;100080065 CEP 2024-468 - Rev 00 2025/02/04 Valid 04/02/2030 Chemical 2025/02/04 New application|CEP granted|04/02/2025
1322 Fenofibrate AALIDHRA PHARMACHEM PRIVATE LIMITED Nandesari IN 100042480;100070177 CEP 2023-157 - Rev 00 2025/02/04 Valid 04/02/2030 Chemical 2025/02/04 New application|CEP granted|04/02/2025
2857 Trazodone hydrochloride ARENE LIFE SCIENCES PRIVATE LIMITED Sangareddy IN 100033956;100079880 CEP 2022-052 - Rev 01 2025/02/04 Valid 17/01/2028 Chemical 2025/02/04 Minor revision|CEP granted|04/02/2025;
Minor revision|Accepted - CEP remains valid|04/10/2024;
New application|CEP granted|17/01/2023
2296 Pantoprazole sodium sesquihydrate SVR DRUGS PRIVATE LIMITED Tadi Village IN 100049140;100082990 CEP 2020-071 - Rev 02 2025/02/04 Valid 13/04/2027 Chemical 2025/02/04 Minor revision|CEP granted|04/02/2025;
Minor revision|CEP granted|20/11/2023;
New application|CEP granted|13/04/2022
335 Hydrocortisone, Process II, Non-micronised and Micronised ZHEJIANG XIANJU PHARMACEUTICAL CO., LTD. Xianju CN 100022759;100031459 CEP 2024-440 - Rev 00 2025/02/04 Valid 04/02/2030 Chemical 2025/02/04 New application|CEP granted|04/02/2025
1756 Lamotrigine ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 CEP 2011-010 - Rev 05 2025/02/03 Valid Chemical 2025/02/03 Minor revision|CEP granted|03/02/2025;
Minor revision|CEP granted|12/07/2024;
Notification|CEP granted|19/06/2023;
Minor revision|CEP granted|18/02/2022;
Minor revision|CEP granted|06/04/2020
1169 Piperacillin monohydrate FRESENIUS KABI IPSUM S.R.L. Cassina de’ Pecchi IT 100015105;100057989 CEP 2012-101 - Rev 05 2025/02/03 Valid Chemical 2025/02/03 Administrative procedure|CEP granted|03/02/2025;
Minor revision|CEP granted|21/01/2025;
Notification|CEP granted|20/03/2023;
Minor revision|Accepted - CEP remains valid|26/08/2022;
Major revision|CEP granted|21/04/2022;
Minor revision|Rejected|21/12/2021;
Monograph revision|CEP granted|23/04/2021
2016 Ondansetron hydrochloride dihydrate CIPLA LIMITED Mumbai IN 100006004;100018147 CEP 2006-279 - Rev 04 2025/02/03 Valid Chemical 2025/02/03 Minor revision|CEP granted|03/02/2025
1280 Zolpidem tartrate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2004-159 - Rev 05 2025/02/03 Valid Chemical 2025/02/03 Minor revision|CEP granted|03/02/2025;
Notification|CEP granted|04/02/2022;
Notification|Accepted - CEP remains valid|10/06/2021;
Monograph revision|Accepted - CEP remains valid|11/06/2020
227 Lidocaine hydrochloride monohydrate SWATI SPENTOSE PVT. LTD. Mumbai IN 100021605;100052219 CEP 2013-103 - Rev 04 2025/02/03 Valid Chemical 2025/02/03 Administrative procedure|CEP granted|03/02/2025;
Minor revision|CEP granted|14/01/2025;
Minor revision|CEP granted|09/10/2024;
Minor revision|CEP granted|10/05/2023
2630 Rivastigmine hydrogen tartrate ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 CEP 2013-069 - Rev 01 2025/02/03 Valid Chemical 2025/02/03 Minor revision|CEP granted|03/02/2025

数据库说明:

当前数据更新日期:2025年12月06日。
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