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
. Foetal Bovine Serum MEDIATECH INC. Woodland US 100051460;100090717 CEP 2020-127 - Rev 01 2026/05/07 Valid TSE 2026/05/07 Renewal|CEP granted|07/05/2026;
New application|CEP granted|15/02/2021
934 Metronidazole benzoate BAJAJ HEALTHCARE LIMITED Thane IN 100021782;100061986 CEP 2023-417 - Rev 01 2026/05/07 Valid 11/09/2029 Chemical 2026/05/07 Monograph revision|CEP granted|07/05/2026;
New application|CEP granted|11/09/2024
1332 Isoprenaline hydrochloride EMCURE PHARMACEUTICALS LIMITED Pune IN 100011677;100099996 CEP 2022-154 - Rev 01 2026/05/07 Valid 21/07/2028 Chemical 2026/05/07 Minor revision|CEP granted|07/05/2026;
New application|CEP granted|21/07/2023
1031 Sodium picosulfate KREATIVE ORGANICS PRIVATE LIMITED Hyderabad IN 100023685;100032852 CEP 2014-020 - Rev 03 2026/05/07 Valid Chemical 2026/05/07 Minor revision|CEP granted|07/05/2026;
Minor revision|CEP granted|20/09/2024;
Major revision|CEP granted|09/09/2021;
Renewal|CEP granted|23/09/2020
661 Cloxacillin sodium, Sterile FRESENIUS KABI IPSUM S.R.L. Cassina de' Pecchi IT 100015105;100057989 CEP 1998-025 - Rev 09 2026/05/07 Valid Chemical 2026/05/07 Minor revision|CEP granted|07/05/2026;
Major revision|CEP granted|10/06/2021;
Minor revision|Accepted - CEP remains valid|06/03/2020
931 Metformin Hydrochloride EXEMED PHARMACEUTICALS Vadodara IN 100019154;100027915 CEP 2011-328 - Rev 03 2026/05/07 Valid Chemical 2026/05/07 Notification|CEP granted|07/05/2026;
Minor revision|Accepted - CEP remains valid|11/02/2025;
Notification|Accepted - CEP remains valid|23/02/2021;
Minor revision|Accepted - CEP remains valid|01/09/2020;
Notification|Accepted - CEP remains valid|13/05/2020
993 Cholesterol, NF CARBOGEN AMCIS B.V. Veenendaal NL 100002010;100009870 CEP 2001-148 - Rev 03 2026/05/07 Valid TSE 2026/05/07 Major revision|CEP granted|07/05/2026
1335 Itraconazole NOSCH LABS PRIVATE LIMITED Hyderabad IN 100020550;100089573 CEP 2011-283 - Rev 02 2026/05/07 Valid Chemical 2026/05/07 Notification|CEP granted|07/05/2026;
Minor revision|CEP granted|05/05/2025;
Minor revision|Rejected|21/02/2025
1420 Enalapril maleate NEULAND LABORATORIES LIMITED Hyderabad IN 100011545;100062134 CEP 2003-078 - Rev 16 2026/05/07 Valid Chemical 2026/05/07 Notification|CEP granted|07/05/2026;
Minor revision|CEP granted|25/08/2025;
Minor revision|Accepted - CEP remains valid|03/10/2023;
Minor revision|CEP granted|07/06/2023;
Notification|CEP granted|24/03/2023;
Notification|CEP granted|07/09/2021;
Notification|CEP granted|04/09/2020
. Newborn Calf Serum HYCLONE LABORATORIES LLC. Logan US 100012797;100022115 CEP 2018-302 - Rev 03 2026/05/07 Valid TSE 2026/05/07 Notification|CEP granted|07/05/2026;
Renewal|CEP granted|13/03/2024;
Notification|Accepted - CEP remains valid|10/05/2022;
Notification|Rejected|25/03/2022;
Notification|CEP granted|24/06/2020
2342 Cefprozil monohydrate, Process II QILU ANTIBIOTICS PHARMACEUTICAL CO. LTD. Jinan CN 100033695;100052910 CEP 2020-252 - Rev 01 2026/05/07 Valid Chemical 2026/05/07 Renewal|CEP granted|07/05/2026;
New application|CEP granted|19/02/2021
760 Cytarabine ASAHI KASEI FINECHEM CO., LTD. Osaka JP 100023625;100101548 CEP 2017-218 - Rev 04 2026/05/07 Valid Chemical 2026/05/07 Notification|CEP granted|07/05/2026;
Minor revision|CEP granted|20/09/2024;
Renewal|CEP granted|14/05/2024;
Minor revision|Accepted - CEP remains valid|11/10/2022;
Minor revision|CEP granted|14/06/2021
2531 Clopidogrel hydrogen sulfate, Form-I PRAVEEN LABORATORIES PRIVATE LIMITED Surat IN 100033525;100087439 CEP 2014-176 - Rev 03 2026/05/07 Valid Chemical 2026/05/07 Minor revision|CEP granted|07/05/2026;
Minor revision|CEP granted|15/12/2025;
Minor revision|CEP granted|21/02/2024;
Renewal|CEP granted|05/11/2020
77 Dapsone EXTROVIS AG Baar CH 100040194;100065405 CEP 2022-379 - Rev 01 2026/05/07 Valid 12/06/2029 Chemical 2026/05/07 Minor revision|CEP granted|07/05/2026;
New application|CEP granted|12/06/2024
2577 Oxcarbazepine, Process-II DASAMI LAB PRIVATE LIMITED Nalgonda IN 100033206;100051825 CEP 2023-348 - Rev 02 2026/05/07 Valid 29/04/2030 Chemical 2026/05/07 Administrative procedure|CEP granted|07/05/2026;
Minor revision|CEP granted|21/04/2026;
New application|CEP granted|29/04/2025
2215 Iodixanol JIANGXI BROTHER PHARMACEUTICAL CO., LTD. Jiujiang City CN 100048879;100081715 CEP 2025-424 - Rev 00 2026/05/07 Valid 07/05/2031 Chemical 2026/05/07 New application|CEP granted|07/05/2026
330 Gelatin, Bovine Limed Hide Gelatin ROUSSELOT B.V. Son En Breugel NL 100051434;100090148 CEP 2025-038 - Rev 00 2026/05/07 Valid 07/05/2031 TSE 2026/05/07 New application|CEP granted|07/05/2026
2423 Valsartan Changzhou Pharmaceutical Factory Changzhou CN 100012704;100018611 CEP 2025-430 - Rev 00 2026/05/07 Valid 07/05/2031 Chemical 2026/05/07 New application|CEP granted|07/05/2026
1573 Sumatriptan succinate NOSCH LABS PRIVATE LIMITED Hyderabad IN 100020550;100089573 CEP 2024-042 - Rev 01 2026/05/07 Valid 27/01/2031 Chemical 2026/05/07 Notification|CEP granted|07/05/2026;
New application|CEP granted|27/01/2026
2531 Clopidogrel hydrogen sulfate, Process B PRAVEEN LABORATORIES PRIVATE LIMITED Jolwa Village IN 100033525;100052476 CEP 2017-247 - Rev 02 2026/05/07 Valid Chemical 2026/05/07 Minor revision|CEP granted|07/05/2026;
Minor revision|CEP granted|19/03/2025;
Renewal|CEP granted|19/12/2022

数据库说明:

当前数据更新日期:2026年05月22日。
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