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
803 Amiodarone hydrochloride ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2003-216 - Rev 10 2025/04/03 Valid Chemical 2025/04/03 Notification|CEP granted|03/04/2025;
Notification|CEP granted|06/12/2022;
Minor revision|CEP granted|16/09/2020
2570 Desloratadine, D304 ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2017-072 - Rev 01 2025/04/03 Valid Chemical 2025/04/03 Notification|CEP granted|03/04/2025;
Renewal|CEP granted|28/11/2022
2192 Atovaquone ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2015-346 - Rev 02 2025/04/03 Valid Chemical 2025/04/03 Notification|CEP granted|03/04/2025;
Notification|CEP granted|02/12/2022;
Renewal|CEP granted|27/07/2022
2445 Adapalene ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2012-207 - Rev 02 2025/04/03 Valid Chemical 2025/04/03 Notification|CEP granted|03/04/2025;
Notification|CEP granted|06/12/2022
1199 Dipyridamole ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2017-023 - Rev 03 2025/04/03 Valid Chemical 2025/04/03 Notification|CEP granted|03/04/2025;
Renewal|CEP granted|12/06/2024;
Notification|CEP granted|02/12/2022
2570 Desloratadine ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2014-047 - Rev 03 2025/04/03 Valid Chemical 2025/04/03 Notification|CEP granted|03/04/2025;
Minor revision|CEP granted|27/03/2023;
Notification|Rejected|23/02/2023;
Notification|CEP granted|02/12/2022;
Renewal|CEP granted|11/09/2020
2933 Deferasirox ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2021-148 - Rev 01 2025/04/03 Valid 04/04/2028 Chemical 2025/04/03 Notification|CEP granted|03/04/2025;
New application|CEP granted|04/04/2023
1499 Cilazapril, D169 ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2014-076 - Rev 02 2025/04/03 Valid Chemical 2025/04/03 Notification|CEP granted|03/04/2025;
Notification|CEP granted|13/12/2022
1499 Cilazapril ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2006-200 - Rev 04 2025/04/03 Valid Chemical 2025/04/03 Notification|CEP granted|03/04/2025;
Notification|CEP granted|02/12/2022
2192 Atovaquone, D144 ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2018-150 - Rev 04 2025/04/03 Valid Chemical 2025/04/03 Notification|CEP granted|03/04/2025;
Renewal|CEP granted|26/06/2024;
Notification|CEP granted|06/12/2022;
Minor revision|CEP granted|09/04/2021
2757 Aprepitant ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2022-365 - Rev 01 2025/04/03 Valid 02/07/2029 Chemical 2025/04/03 Notification|CEP granted|03/04/2025;
New application|CEP granted|02/07/2024
734 Prednisolone acetate FARMABIOS S.p.A Gropello Cairoli IT 100011643;100021232 CEP 2019-109 - Rev 01 2025/04/02 Valid Chemical 2025/04/02 Renewal|CEP granted|02/04/2025
577 Amoxicillin sodium, Sterile FRESENIUS KABI IPSUM S.R.L. Cassina de’ Pecchi IT 100015105;100057989 CEP 2008-267 - Rev 08 2025/04/02 Valid Chemical 2026/01/26 Major revision|Rejected|26/01/2026;
Major revision|CEP granted|02/04/2025;
Minor revision|CEP granted|12/10/2022;
Minor revision|CEP granted|09/07/2021;
Notification|CEP granted|11/02/2021;
Minor revision|CEP granted|28/10/2020
2579 Saw palmetto extract, DER 9-11:1 - code number 0285271BC Finzelberg GmbH & Co. KG Andernach DE 100014516;100022034 CEP 2020-001 - Rev 01 2025/04/02 Valid Herbal 2025/04/02 Renewal|CEP granted|02/04/2025;
Monograph revision|Accepted - CEP remains valid|20/06/2024;
New application|CEP granted|28/05/2020
1705 Sertraline hydrochloride, Polymorphic Form-II, Process-2, Viyash Life Sciences Private Limited Unit-II, SHD VIYASH LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100040217;100065484 CEP 2024-497 - Rev 00 2025/04/02 Valid 02/04/2030 Chemical 2025/04/02 New application|CEP granted|02/04/2025
1156 Tenoxicam EDMOND PHARMA S.R.L. Paderno Dugnano IT 100000246;100002746 CEP 1998-057 - Rev 06 2025/04/02 Valid Chemical 2025/04/02 Notification|CEP granted|02/04/2025;
Minor revision|CEP granted|04/01/2022
1558 Propofol HARMAN FINOCHEM LIMITED Mumbai IN 100011528;100020515 CEP 2015-347 - Rev 02 2025/04/02 Valid Chemical 2025/04/02 Administrative procedure|CEP granted|02/04/2025;
Minor revision|CEP granted|21/03/2025;
Renewal|CEP granted|28/07/2022;
Minor revision|CEP granted|02/11/2020
1094 Cyproterone acetate CIPLA LIMITED Mumbai IN 100006004;100018147 CEP 2007-038 - Rev 04 2025/04/02 Valid Chemical 2025/04/02 Minor revision|CEP granted|02/04/2025
2932 Rivaroxaban ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2022-021 - Rev 00 2025/04/02 Valid 02/04/2030 Chemical 2025/04/02 New application|CEP granted|02/04/2025
1734 Terbinafine hydrochloride DR. REDDY'S LABORATORIES LIMITED Hyderabad IN 100003991;100000217 CEP 2009-008 - Rev 03 2025/04/02 Valid Chemical 2025/04/02 Notification|CEP granted|02/04/2025;
Minor revision|Accepted - CEP remains valid|21/01/2025;
Notification|Rejected|10/01/2025

数据库说明:

当前数据更新日期:2026年02月10日。
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