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
2191 Atorvastatin calcium, Site 2 ZHEJIANG JIANGBEI NANHAI PHARMACEUTICAL CO., LTD Linhai City CN 100049395;100084081 CEP 2023-160 - Rev 01 2025/01/23 Valid 17/08/2028 Chemical 2025/08/22 Major revision|Accepted - CEP remains valid|22/08/2025;
Minor revision|CEP granted|23/01/2025;
New application|CEP granted|17/08/2023
599 Cisplatin VERANOVA, L.P. West Deptford US 100012273;100018937 CEP 2005-253 - Rev 02 2025/01/22 Valid Chemical 2025/01/22 Minor revision|CEP granted|22/01/2025;
Notification|CEP granted|29/11/2023
653 Baclofen, Milled, sieved EXCELLA GMBH & CO. KG Feucht DE 100012030;100020739 CEP 2007-238 - Rev 05 2025/01/22 Valid Chemical 2025/01/22 Monograph revision|CEP granted|22/01/2025;
Minor revision|CEP granted|11/01/2024;
Minor revision|CEP granted|16/11/2020;
Minor revision|Accepted - CEP remains valid|24/02/2020
888 Ciprofloxacin Hydrochloride BAYER AG Leverkusen DE 100000011;100001505 CEP 1998-103 - Rev 07 2025/01/22 Valid Chemical 2025/01/22 Minor revision|CEP granted|22/01/2025
548 Dexamethasone acetate EUROAPI FRANCE Vertolaye FR 100039327;100061906 CEP 1998-089 - Rev 08 2025/01/22 Valid Chemical 2025/01/22 Minor revision|CEP granted|22/01/2025;
Transfer of holdership|CEP granted|16/12/2021
560 Methotrexate FERMION OY Espoo FI 100011508;100020280 CEP 2001-145 - Rev 05 2025/01/22 Valid Chemical 2025/10/01 Notification|Accepted - CEP remains valid|01/10/2025;
Minor revision|CEP granted|22/01/2025;
Notification|Accepted - CEP remains valid|26/10/2022;
Minor revision|Accepted - CEP remains valid|28/01/2022
653 Baclofen COHANCE LIFESCIENCES LIMITED Hyderabad IN 100011755;100021186 CEP 2018-280 - Rev 02 2025/01/22 Valid 17/06/2026 Chemical 2025/01/22 Minor revision|CEP granted|22/01/2025;
Notification|CEP granted|15/12/2022
2333 Fluvastatin sodium, Crystalline BIOCON LIMITED Bengaluru IN 100011487;100018595 CEP 2018-182 - Rev 03 2025/01/22 Valid Chemical 2025/01/22 Minor revision|CEP granted|22/01/2025;
Renewal|CEP granted|25/03/2024;
Major revision|Rejected|20/09/2021;
Minor revision|CEP granted|20/02/2020
92 Indometacin CSPC OUYI PHARMACEUTICAL CO., LTD. Shijiazhuang CN 100022915;100052600 CEP 2008-004 - Rev 07 2025/01/22 Valid Chemical 2025/03/04 Minor revision|Accepted - CEP remains valid|04/03/2025;
Minor revision|CEP granted|22/01/2025;
Minor revision|Accepted - CEP remains valid|02/11/2021
2779 Solifenacin succinate, Micronised, non-micronised ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 CEP 2016-131 - Rev 02 2025/01/22 Valid Chemical 2025/06/02 Major revision|Rejected|02/06/2025;
Minor revision|CEP granted|22/01/2025;
Minor revision|CEP granted|02/04/2024;
Renewal|CEP granted|09/05/2022
645 Tobramycin LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN 100020920;100029633 CEP 2020-394 - Rev 02 2025/01/22 Valid 12/07/2027 Chemical 2025/01/22 Minor revision|CEP granted|22/01/2025;
Minor revision|Accepted - CEP remains valid|04/08/2023;
Minor revision|CEP granted|02/02/2023;
New application|CEP granted|12/07/2022
768 Hydrocortisone hydrogen succinate BIOFER SPA Milano IT 100007069;100094164 CEP 2019-039 - Rev 03 2025/01/22 Valid Chemical 2025/01/22 Renewal|CEP granted|22/01/2025;
Major revision|CEP granted|21/04/2023;
Notification|CEP granted|20/04/2022
3087 Ticagrelor, Form II, micronised INTAS PHARMACEUTICALS LIMITED Ahmedabad IN 100011529;100023432 CEP 2022-333 - Rev 01 2025/01/22 Valid 02/08/2029 Chemical 2025/01/22 Minor revision|CEP granted|22/01/2025;
New application|CEP granted|02/08/2024
678 Sodium valproate, Process III SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2023-252 - Rev 01 2025/01/22 Valid 12/12/2028 Chemical 2025/01/22 Minor revision|CEP granted|22/01/2025;
New application|CEP granted|12/12/2023
3036 Teriflunomide SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN 100044578;100073706 CEP 2023-313 - Rev 00 2025/01/22 Valid 22/01/2030 Chemical 2025/01/22 New application|CEP granted|22/01/2025
2779 Solifenacin succinate, Process-II OPTIMUS DRUGS PRIVATE LIMITED Hyderabad IN 100020646;100092226 CEP 2024-372 - Rev 00 2025/01/22 Valid 22/01/2030 Chemical 2025/01/22 New application|CEP granted|22/01/2025
1326 Flumazenil HUBEI HAOSUN PHARMACEUTICAL CO., LTD. Ezhou CN 100012046;100019090 CEP 2008-121 - Rev 03 2025/01/21 Valid Chemical 2025/01/21 Minor revision|CEP granted|21/01/2025;
Minor revision|CEP granted|14/09/2023
1767 Tilidine hydrochloride hemihydrate AREVIPHARMA GMBH Radebeul DE 100011616;100022155 CEP 2006-013 - Rev 03 2025/01/21 Valid Chemical 2025/01/21 Minor revision|CEP granted|21/01/2025;
Monograph revision|CEP granted|15/10/2020
1573 Sumatriptan succinate DR. REDDY'S LABORATORIES LIMITED Hyderabad IN 100003991;100000217 CEP 2002-246 - Rev 10 2025/01/21 Valid Chemical 2025/01/21 Notification|CEP granted|21/01/2025;
Minor revision|CEP granted|01/07/2024;
Notification|CEP granted|23/05/2023
902 Ferrous fumarate DR. PAUL LOHMANN GMBH & CO. KGAA Emmerthal DE 100022728;100031429 CEP 2004-232 - Rev 04 2025/01/21 Valid Chemical 2025/01/21 Minor revision|CEP granted|21/01/2025;
Minor revision|Accepted - CEP remains valid|25/11/2021;
Monograph revision|CEP granted|13/07/2021;
Notification|CEP granted|27/02/2020

数据库说明:

当前数据更新日期:2025年12月06日。
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