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
22 Diazepam R L FINE CHEM PVT. LTD. Gowribidanur IN R0-CEP 2019-264 - Rev 02 2023/08/16 Valid 07/12/2026 Chemical 2023/08/16 Minor revision|CEP granted|16/08/2023;
Minor revision|CEP granted|20/04/2022
2637 Pemetrexed disodium heptahydrate MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN R0-CEP 2020-336 - Rev 01 2023/08/16 Valid 09/12/2027 Chemical 2023/08/16 Notification|CEP granted|16/08/2023;
Monograph revision|Accepted - CEP remains valid|18/07/2023;
New application|CEP granted|09/12/2022
1115 Iopamidol, Process 2 ZHEJIANG STARRY PHARMACEUTICAL CO., LTD. Xianju CN R0-CEP 2022-050 - Rev 01 2023/08/16 Valid 28/07/2028 Chemical 2023/08/16 Administrative procedure|CEP granted|16/08/2023;
New application|CEP granted|28/07/2023
2154 Telmisartan ZHUHAI RUNDU PHARMACEUTICAL CO., LTD. Sanzao Town CN R0-CEP 2022-179 - Rev 00 2023/08/16 Valid 16/08/2028 Chemical 2023/08/16 New application|CEP granted|16/08/2023
2591 Celecoxib, Site Khazipally AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN R0-CEP 2023-194 - Rev 00 2023/08/16 Valid 16/08/2028 Chemical 2023/08/16 New application|CEP granted|16/08/2023
2762 Capecitabine MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN R1-CEP 2015-391 - Rev 02 2023/08/16 Valid Chemical 2023/08/16 Notification|CEP granted|16/08/2023;
Minor revision|CEP granted|07/03/2023;
Renewal|CEP granted|20/12/2021;
Minor revision|CEP granted|06/01/2021
2779 Solifenacin succinate CIPLA LIMITED Mumbai IN R1-CEP 2017-062 - Rev 00 2023/08/16 Valid Chemical 2023/08/16 Renewal|CEP granted|16/08/2023;
Notification|Accepted - CEP remains valid|26/04/2022
2988 Fingolimod hydrochloride MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN R0-CEP 2019-290 - Rev 01 2023/08/11 Valid 27/09/2026 Chemical 2024/04/23 Monograph revision|Accepted - CEP remains valid|23/04/2024;
Notification|CEP granted|11/08/2023;
Minor revision|Accepted - CEP remains valid|20/01/2023
2778 Sitagliptin phosphate monohydrate BIOCON LIMITED Bengaluru IN R0-CEP 2020-197 - Rev 00 2023/08/11 Valid 11/08/2028 Chemical 2023/08/11 New application|CEP granted|11/08/2023
2988 Fingolimod hydrochloride, Form-I MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN R0-CEP 2021-066 - Rev 01 2023/08/11 Valid 13/03/2028 Chemical 2023/08/11 Notification|CEP granted|11/08/2023;
New application|CEP granted|13/03/2023
576 Allopurinol HETERO DRUGS LIMITED Hyderabad IN R0-CEP 2021-074 - Rev 01 2023/08/11 Valid 08/03/2028 Chemical 2023/08/11 Minor revision|CEP granted|11/08/2023;
Notification|Accepted - CEP remains valid|11/04/2023;
New application|CEP granted|08/03/2023
2174 Cladribine MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN R0-CEP 2021-217 - Rev 01 2023/08/11 Valid 25/05/2028 Chemical 2023/08/11 Notification|CEP granted|11/08/2023;
New application|CEP granted|26/05/2023
1563 Simvastatin, with 0.2% butylated hydroxy anisole KREBS BIOCHEMICALS & INDUSTRIES LIMITED Kothapalli IN R1-CEP 2007-210 - Rev 02 2023/08/11 Valid Chemical 2023/08/11 Minor revision|CEP granted|11/08/2023
2570 Desloratadine ROLABO OUTSOURCING, S.L. Zaragoza ES R1-CEP 2017-303 - Rev 00 2023/08/11 Valid Chemical 2023/08/11 Renewal|CEP granted|11/08/2023
248 Suxamethonium Chloride TAKEDA GMBH Konstanz DE R2-CEP 1995-021 - Rev 10 2023/08/11 Valid Chemical 2023/08/11 Notification|CEP granted|11/08/2023;
Major revision|CEP granted|18/03/2022;
Notification|CEP granted|21/04/2020
2910 Trifluridine MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN R0-CEP 2021-202 - Rev 01 2023/08/10 Valid 15/02/2028 Chemical 2023/08/10 Notification|CEP granted|10/08/2023;
New application|CEP granted|15/02/2023
67 Folic acid hydrate DSM Nutritional Products Ltd. Kaiseraugst CH R1-CEP 1996-045 - Rev 06 2023/08/10 Valid Chemical 2023/08/10 Administrative procedure|CEP granted|10/08/2023;
Minor revision|CEP granted|06/07/2023;
Monograph revision|Accepted - CEP remains valid|11/05/2022;
Minor revision|CEP granted|27/04/2021
1314 Dosulepin hydrochloride SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN R1-CEP 2003-157 - Rev 05 2023/08/10 Valid Chemical 2023/08/10 Minor revision|CEP granted|10/08/2023
890 Clonazepam LAKE CHEMICALS PRIVATE LIMITED Bengaluru IN R1-CEP 2009-101 - Rev 01 2023/08/10 Valid Chemical 2023/08/10 Minor revision|CEP granted|10/08/2023
2196 Bicalutamide MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN R1-CEP 2012-283 - Rev 01 2023/08/10 Valid Chemical 2023/08/10 Notification|CEP granted|10/08/2023

数据库说明:

当前数据更新日期:2024年08月17日。
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