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
2858 Mometasone furoate monohydrate, Micronised CIPLA LIMITED Mumbai IN 100006004;100018147 CEP 2018-290 - Rev 02 2025/06/18 Valid Chemical 2025/06/18 Minor revision|CEP granted|18/06/2025;
Renewal|CEP granted|23/01/2025
1346 Metamizole sodium monohydrate HEBEI JIHENG PHARMACEUTICAL CO., LTD. Hengshui City CN 100016565;100052147 CEP 2005-143 - Rev 03 2025/06/18 Valid Chemical 2025/06/18 Minor revision|CEP granted|18/06/2025;
Minor revision|CEP granted|03/03/2021
2732 Dienogest STERLING S.p.A. Solomeo Di Corciano IT 100024377;100033551 CEP 2016-158 - Rev 01 2025/06/18 Valid Chemical 2025/06/18 Major revision|CEP granted|18/06/2025;
Renewal|CEP granted|02/08/2023
2762 Capecitabine SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN 100044578;100073706 CEP 2014-332 - Rev 03 2025/06/18 Valid Chemical 2025/06/18 Minor revision|CEP granted|18/06/2025;
Notification|Accepted - CEP remains valid|26/10/2023;
Minor revision|CEP granted|07/02/2023;
Notification|CEP granted|20/07/2022;
Renewal|CEP granted|30/09/2021;
Minor revision|Accepted - CEP remains valid|30/07/2020
464 Amitriptyline hydrochloride MANKIND PHARMA LIMITED New Delhi IN 100040218;100065486 CEP 2019-227 - Rev 01 2025/06/18 Valid 16/07/2026 Chemical 2025/06/18 Notification|CEP granted|18/06/2025
2856 Pirfenidone MICRO LABS LIMITED Bengaluru IN 100017819;100077269 CEP 2019-155 - Rev 02 2025/06/18 Valid Chemical 2025/06/18 Renewal|CEP granted|18/06/2025;
Minor revision|CEP granted|16/11/2022
2296 Pantoprazole sodium sesquihydrate MANKIND PHARMA LIMITED New Delhi IN 100040218;100065486 CEP 2021-073 - Rev 01 2025/06/18 Valid 14/11/2027 Chemical 2025/06/18 Notification|CEP granted|18/06/2025;
New application|CEP granted|14/11/2022
2358 Teicoplanin, Process II LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN 100020920;100029633 CEP 2025-047 - Rev 00 2025/06/18 Valid 18/06/2030 Chemical 2025/06/18 New application|CEP granted|18/06/2025
272 Doxycycline hyclate, Process Ⅱ SHANDONG GUOBANG PHARMACEUTICAL CO., LTD. Weifang CN 100036834;100058198 CEP 2025-191 - Rev 00 2025/06/18 Valid 18/06/2030 Chemical 2025/06/18 New application|CEP granted|18/06/2025
2404 Drospirenone, Code 202900 STERLING CHEMICAL MALTA LTD. Birzebbugia MT 100021162;100039059 CEP 2023-457 - Rev 00 2025/06/18 Valid 18/06/2030 Chemical 2025/06/18 New application|CEP granted|18/06/2025
2307 Modafinil SYMED LABS LIMITED Hyderabad IN 100018727;100053490 CEP 2024-098 - Rev 00 2025/06/18 Valid 18/06/2030 Chemical 2025/06/18 New application|CEP granted|18/06/2025
2284 Calcipotriol monohydrate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2014-016 - Rev 02 2025/06/17 Valid Chemical 2025/06/17 Notification|CEP granted|17/06/2025;
Notification|CEP granted|20/12/2021
698 Warfarin sodium CHIERON ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN 100053345;100094249 CEP 2008-321 - Rev 02 2025/06/17 Valid Chemical 2025/06/17 Notification|CEP granted|17/06/2025
57 Tetracaine hydrochloride CHIERON ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN 100053345;100094249 CEP 2010-256 - Rev 02 2025/06/17 Valid Chemical 2025/06/17 Notification|CEP granted|17/06/2025;
Monograph revision|Accepted - CEP remains valid|20/04/2022
2541 Quetiapine Fumarate, Process-II APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2023-005 - Rev 02 2025/06/17 Valid 12/12/2028 Chemical 2025/06/17 Minor revision|CEP granted|17/06/2025;
Notification|Rejected|15/05/2025;
Notification|CEP granted|12/04/2024;
New application|CEP granted|12/12/2023
253 Ascorbic acid NORTHEAST PHARMACEUTICAL GROUP CO. LTD Shenyang CN 100021339;100054155 CEP 2022-066 - Rev 01 2025/06/17 Valid 14/06/2029 Chemical 2025/06/17 Notification|CEP granted|17/06/2025;
New application|CEP granted|14/06/2024
699 Warfarin sodium clathrate CHIERON ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN 100053345;100094249 CEP 2021-450 - Rev 01 2025/06/17 Valid 05/02/2029 Chemical 2025/06/17 Notification|CEP granted|17/06/2025;
New application|CEP granted|05/02/2024
2054 Clofazimine, Triclinic form MIDAS PHARMA GMBH Ingelheim am Rhein DE 100001328;100004656 CEP 2019-257 - Rev 02 2025/06/17 Valid 15/10/2026 Chemical 2025/06/17 Minor revision|CEP granted|17/06/2025;
Notification|CEP granted|27/01/2023;
Minor revision|Accepted - CEP remains valid|16/02/2022
2778 Sitagliptin phosphate monohydrate, 1567 MACLEODS PHARMACEUTICALS LIMITED Mumbai IN 100021441;100077265 CEP 2024-229 - Rev 01 2025/06/17 Valid 10/04/2030 Chemical 2025/06/17 Minor revision|CEP granted|17/06/2025;
New application|CEP granted|10/04/2025
922 Ketoprofen SNJ LIFECARE PRIVATE LIMITED 363 650 IN 100051847;100091285 CEP 2024-281 - Rev 00 2025/06/17 Valid 17/06/2030 Chemical 2025/06/17 New application|CEP granted|17/06/2025

数据库说明:

当前数据更新日期:2026年02月12日。
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