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
1681 Tramadol hydrochloride EMNAR PHARMA PRIVATE LIMITED Hyderabad IN 100033980;100065255 CEP 2013-320 - Rev 03 2026/02/25 Valid Chemical 2026/02/25 Minor revision|CEP granted|25/02/2026;
Notification|CEP granted|27/10/2023;
Major revision|CEP granted|03/02/2022;
Minor revision|Rejected|19/07/2021;
Renewal|CEP granted|10/08/2020
928 Lomustine DR. REDDY'S LABORATORIES LIMITED Hyderabad IN 100003991;100000217 CEP 2009-141 - Rev 04 2026/02/23 Valid Chemical 2026/02/23 Minor revision|CEP granted|23/02/2026;
Notification|Rejected|12/01/2026;
Minor revision|CEP granted|16/08/2024;
Minor revision|Accepted - CEP remains valid|25/02/2021
464 Amitriptyline hydrochloride TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2001-432 - Rev 07 2026/02/23 Valid Chemical 2026/02/23 Major revision|CEP granted|23/02/2026;
Notification|CEP granted|11/03/2025;
Minor revision|CEP granted|07/05/2024;
Notification|Accepted - CEP remains valid|05/07/2023;
Notification|Accepted - CEP remains valid|02/08/2022;
Notification|CEP granted|04/02/2022;
Minor revision|Accepted - CEP remains valid|12/10/2021;
Notification|Rejected|16/08/2021
417 Oxygen LINDE GMBH Pullach I. Isartal DE 100017889;100043514 CEP 2019-005 - Rev 06 2026/02/23 Valid Chemical 2026/02/23 Notification|CEP granted|23/02/2026;
Renewal|Accepted - CEP remains valid|31/01/2025;
Notification|CEP granted|05/06/2024;
Minor revision|CEP granted|09/02/2024;
Notification|Accepted - CEP remains valid|12/12/2022;
Minor revision|CEP granted|11/04/2022;
Notification|CEP granted|21/01/2021;
Notification|CEP granted|30/10/2020
2131 Tamsulosin hydrochloride COHANCE LIFESCIENCES LIMITED Mumbai IN 100011755;100090273 CEP 2007-014 - Rev 06 2026/02/23 Valid Chemical 2026/02/23 Notification|CEP granted|23/02/2026;
Notification|CEP granted|15/05/2020
809 Betamethasone dipropionate, Micronised TARO PHARMACEUTICAL INDUSTRIES, LTD. Haifa IL 100004559;100001120 CEP 2018-018 - Rev 04 2026/02/23 Valid Chemical 2026/02/18 Minor revision|CEP granted|18/02/2026;
Minor revision|CEP granted|19/05/2025;
Renewal|CEP granted|19/03/2024
2760 Brimonidine tartrate FDC Limited Mumbai IN 100011646;100021030 CEP 2020-123 - Rev 01 2026/02/23 Valid 13/06/2027 Chemical 2026/02/23 Minor revision|CEP granted|23/02/2026;
New application|CEP granted|13/06/2022
417 Oxygen SOL S.P.A. Monza IT 100002061;100001723 CEP 2020-295 - Rev 01 2026/02/23 Valid Chemical 2026/02/23 Renewal|CEP granted|23/02/2026;
New application|CEP granted|10/05/2021
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
3139 Brivaracetam ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2024-088 - Rev 01 2026/02/23 Valid 02/06/2030 Chemical 2026/02/23 Major revision|CEP granted|23/02/2026;
New application|CEP granted|02/06/2025
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

数据库说明:

当前数据更新日期:2026年04月03日。
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