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
2119 Venlafaxine hydrochloride, Process II QUIMICA SINTETICA S.A. Alcala De Henares ES 100012121;100019020 CEP 2021-131 - Rev 01 2026/02/23 Valid Chemical 2026/02/23 Renewal|CEP granted|23/02/2026;
New application|CEP granted|01/06/2021
1722 Flunarizine dihydrochloride HIKAL LIMITED Bengaluru IN 100014769;100023445 CEP 2019-094 - Rev 03 2026/02/23 Valid Chemical 2026/02/23 Renewal|CEP granted|23/02/2026;
Monograph revision|CEP granted|27/10/2023;
Notification|CEP granted|14/09/2022
2414 Octreotide BACHEM AG Bubendorf CH 100011626;100021354 CEP 2020-229 - Rev 02 2026/02/23 Valid Chemical 2026/02/23 Renewal|CEP granted|23/02/2026;
Minor revision|CEP granted|18/07/2022;
New application|CEP granted|31/03/2021
1700 Mycophenolate mofetil, Process II RPG LIFE SCIENCES LIMITED Navi Mumbai IN 100017119;100025920 CEP 2025-548 - Rev 00 2026/02/23 Valid 23/02/2031 Chemical 2026/02/23 New application|CEP granted|23/02/2026
2790 Clopidogrel besilate IOL CHEMICALS AND PHARMACEUTICALS LIMITED Ludhiana IN 100017919;100037377 CEP 2024-570 - Rev 00 2026/02/23 Valid 23/02/2031 Chemical 2026/02/23 New application|CEP granted|23/02/2026
645 Tobramycin LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN 100020920;100029633 CEP 2020-394 - Rev 03 2026/02/23 Valid 12/07/2027 Chemical 2026/02/23 Minor revision|CEP granted|23/02/2026;
Monograph revision|Accepted - CEP remains valid|21/01/2026;
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
521 Phenytoin sodium, Micronised, non-micronised KATWIJK CHEMIE BV Katwijk ZH NL 100019011;100027776 CEP 2015-151 - Rev 01 2026/02/23 Valid Chemical 2026/02/23 Minor revision|CEP granted|23/02/2026;
Renewal|CEP granted|14/10/2020
1585 Acamprosate calcium EMCURE PHARMACEUTICALS LIMITED Pune IN 100011677;100099996 CEP 2024-426 - Rev 00 2026/02/23 Valid 23/02/2031 Chemical 2026/02/23 New application|CEP granted|23/02/2026
2306 Gemcitabine hydrochloride, Process III INTAS PHARMACEUTICALS LIMITED Ahmedabad IN 100011529;100023432 CEP 2022-092 - Rev 03 2026/02/23 Valid 13/07/2027 Chemical 2026/02/23 Minor revision|CEP granted|23/02/2026;
Minor revision|CEP granted|26/05/2025;
Minor revision|CEP granted|02/09/2024;
Minor revision|Accepted - CEP remains valid|07/11/2023;
Notification|Rejected|08/09/2023;
New application|CEP granted|13/07/2022
1324 Flecainide acetate, FLI EMCURE PHARMACEUTICALS LIMITED Pune IN 100011677;100099996 CEP 2025-458 - Rev 00 2026/02/20 Valid 20/02/2031 Chemical 2026/02/20 New application|CEP granted|20/02/2026
890 Clonazepam R.L. FINE CHEM PRIVATE LIMITED Chikkaballapur IN 100016723;100053383 CEP 2023-053 - Rev 01 2026/02/20 Valid 26/02/2030 Chemical 2026/02/20 Monograph revision|CEP granted|20/02/2026;
New application|CEP granted|26/02/2025
1694 Gemfibrozil HIKAL LIMITED Bengaluru IN 100014769;100023445 CEP 2007-089 - Rev 06 2026/02/19 Valid Chemical 2026/02/19 Minor revision|CEP granted|19/02/2026;
Minor revision|Accepted - CEP remains valid|23/01/2023;
Notification|Rejected|06/12/2022;
Notification|CEP granted|07/09/2022;
Minor revision|Accepted - CEP remains valid|20/02/2020
562 Sodium cromoglicate SANOFI AVENTIS SINGAPORE PTE LTD Singapore SG 100005144;100008271 CEP 2001-421 - Rev 04 2026/02/19 Valid Chemical 2026/02/19 Notification|CEP granted|19/02/2026;
Minor revision|Accepted - CEP remains valid|10/08/2022;
Monograph revision|Accepted - CEP remains valid|16/06/2021
1096 Doxepin hydrochloride TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 1999-197 - Rev 06 2026/02/19 Valid Chemical 2026/02/19 Major revision|CEP granted|19/02/2026;
Minor revision|CEP granted|07/05/2025;
Minor revision|Accepted - CEP remains valid|26/06/2023;
Minor revision|CEP granted|08/12/2021;
Minor revision|Accepted - CEP remains valid|12/06/2020
568 Propranolol hydrochloride IPCA LABORATORIES LIMITED Mumbai IN 100011685;100018680 CEP 2002-026 - Rev 07 2026/02/19 Valid Chemical 2026/02/19 Minor revision|CEP granted|19/02/2026;
Minor revision|CEP granted|06/12/2023;
Notification|CEP granted|03/08/2023;
Minor revision|CEP granted|22/05/2023;
Minor revision|Accepted - CEP remains valid|15/07/2022;
Minor revision|CEP granted|21/09/2021;
Minor revision|Accepted - CEP remains valid|01/04/2021;
Minor revision|Accepted - CEP remains valid|13/03/2020
576 Allopurinol EXEMED PHARMACEUTICALS Vadodara IN 100019154;100027915 CEP 2021-331 - Rev 01 2026/02/19 Valid 30/11/2027 Chemical 2026/02/19 Minor revision|CEP granted|19/02/2026;
Notification|Rejected|26/11/2025;
New application|CEP granted|01/12/2022
3087 Ticagrelor ZHEJIANG HISUN PHARMACEUTICAL CO., LTD. Taizhou City CN 100011825;100018687 CEP 2024-020 - Rev 00 2026/02/19 Valid 19/02/2031 Chemical 2026/02/19 New application|CEP granted|19/02/2026
1792 Nicotine resinate, Nicotine content 18% with glycerol 9.0-11.0% ALCHEM INTERNATIONAL PRIVATE LIMITED Faridabad IN 100011947;100018683 CEP 2019-030 - Rev 03 2026/02/19 Valid Chemical 2026/02/19 Minor revision|CEP granted|19/02/2026;
Renewal|Accepted - CEP remains valid|17/10/2025;
Minor revision|CEP granted|19/05/2025;
Minor revision|CEP granted|01/08/2022;
Notification|Rejected|23/02/2022
2858 Mometasone furoate monohydrate, Micronised and non-micronised BREATHGREEN PHARMACEUTICAL CO. LTD. Zaozhuang CN 100048781;100081153 CEP 2025-357 - Rev 00 2026/02/19 Valid 19/02/2031 Chemical 2026/02/19 New application|CEP granted|19/02/2026
2606 Tadalafil SHANDONG CHENGHUI SHUANGDA PHARMACEUTICAL CO., LTD. Dezhou CN 100048410;100080174 CEP 2025-131 - Rev 01 2026/02/19 Valid 22/10/2030 Chemical 2026/02/19 Minor revision|CEP granted|19/02/2026;
New application|CEP granted|22/10/2025

数据库说明:

当前数据更新日期:2026年05月28日。
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