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
1658 Spectinomycin sulfate tetrahydrate for veterinary use HEBEI SHENGXUE DACHENG PHARMACEUTICAL CO. LTD. Shijiazhuang City CN 100016575;100025368 CEP 2020-069 - Rev 02 2025/09/18 Valid Chemical 2025/09/18 Renewal|CEP granted|18/09/2025;
Minor revision|CEP granted|06/05/2024;
New application|CEP granted|27/01/2021
884 Carbimazole APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2017-201 - Rev 02 2025/09/18 Valid Chemical 2025/09/18 Minor revision|CEP granted|18/09/2025;
Notification|CEP granted|16/01/2024;
Renewal|CEP granted|13/03/2023;
Minor revision|CEP granted|15/06/2022;
Notification|Accepted - CEP remains valid|12/08/2021;
Minor revision|CEP granted|12/03/2020
2573 Candesartan cilexetil, Process 2 ZHUHAI RUNDU PHARMACEUTICAL CO., LTD. Zhuhai City CN 100033558;100052545 CEP 2023-096 - Rev 01 2025/09/18 Valid 19/05/2028 Chemical 2025/12/10 Notification|Accepted - CEP remains valid|10/12/2025;
Major revision|CEP granted|18/09/2025;
New application|CEP granted|19/05/2023
2334 Letrozole TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2022-209 - Rev 02 2025/09/18 Valid 18/03/2029 Chemical 2025/09/18 Minor revision|CEP granted|18/09/2025;
Notification|CEP granted|10/03/2025;
New application|CEP granted|18/03/2024
968 Aciclovir MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 1998-029 - Rev 11 2025/09/17 Valid Chemical 2025/09/17 Notification|CEP granted|17/09/2025;
Notification|CEP granted|12/07/2024;
Monograph revision|Accepted - CEP remains valid|24/06/2021;
Minor revision|CEP granted|23/02/2021
2589 Abacavir sulfate MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2013-141 - Rev 02 2025/09/17 Valid Chemical 2025/09/17 Notification|CEP granted|17/09/2025;
Notification|CEP granted|19/07/2024;
Minor revision|Accepted - CEP remains valid|12/04/2022;
Minor revision|Accepted - CEP remains valid|09/12/2020
2244 Tacrolimus monohydrate FISHFA BIOGENICS Rajkot IN 100044306;100073256 CEP 2023-394 - Rev 00 2025/09/17 Valid 17/09/2030 Chemical 2025/09/17 New application|CEP granted|17/09/2025
2154 Telmisartan MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2008-256 - Rev 04 2025/09/17 Valid Chemical 2025/09/17 Notification|CEP granted|17/09/2025;
Notification|CEP granted|11/07/2024;
Minor revision|CEP granted|04/10/2023
2777 Pregabalin MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2016-207 - Rev 02 2025/09/17 Valid Chemical 2025/09/17 Notification|CEP granted|17/09/2025;
Notification|CEP granted|29/07/2024;
Renewal|CEP granted|06/12/2022;
Notification|CEP granted|01/09/2021
1032 Omeprazole sodium SHOUGUANG FUKANG PHARMACEUTICAL CO., LTD. Shouguang City CN 100017920;100052986 CEP 2025-121 - Rev 00 2025/09/17 Valid 17/09/2030 Chemical 2025/09/17 New application|CEP granted|17/09/2025
2449 Docetaxel trihydrate, Shandong Anxin site SHANDONG ANXIN PHARMACEUTICAL CO., LTD Jinan CN 100012114;100052387 CEP 2025-133 - Rev 00 2025/09/17 Valid 17/09/2030 Chemical 2025/09/17 New application|CEP granted|17/09/2025
2887 Raltegravir potassium, Form-3 AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100046306;100076393 CEP 2024-499 - Rev 00 2025/09/17 Valid 17/09/2030 Chemical 2025/10/24 Minor revision|Accepted - CEP remains valid|24/10/2025;
New application|CEP granted|17/09/2025
543 Carbamazepine ARENE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100033956;100079880 CEP 2024-233 - Rev 00 2025/09/17 Valid 17/09/2030 Chemical 2025/09/17 New application|CEP granted|17/09/2025
1115 Iopamidol, Product C02 ZHEJIANG TAIZHOU HISYN PHARMACEUTICAL CO., LTD. Linhai CN 100024981;100087091 CEP 2025-334 - Rev 00 2025/09/17 Valid 17/09/2030 Chemical 2025/09/17 New application|CEP granted|17/09/2025
1573 Sumatriptan succinate MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2009-156 - Rev 04 2025/09/16 Valid Chemical 2025/09/16 Notification|CEP granted|16/09/2025;
Notification|CEP granted|22/07/2024;
Notification|CEP granted|31/08/2021
1789 Nadolol MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2009-372 - Rev 05 2025/09/16 Valid Chemical 2025/09/16 Notification|CEP granted|16/09/2025;
Notification|CEP granted|22/07/2024;
Notification|CEP granted|01/09/2021
2594 Duloxetine hydrochloride MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2012-203 - Rev 04 2025/09/16 Valid Chemical 2025/09/16 Notification|CEP granted|16/09/2025;
Notification|CEP granted|26/07/2024;
Notification|Accepted - CEP remains valid|17/06/2022;
Notification|CEP granted|01/09/2021;
Major revision|CEP granted|11/06/2020;
Major revision|Rejected|16/03/2020
2019 Perindopril tert-butylamine MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2010-157 - Rev 06 2025/09/16 Valid Chemical 2025/09/16 Notification|CEP granted|16/09/2025;
Notification|CEP granted|08/08/2024;
Minor revision|CEP granted|22/01/2021;
Monograph revision|Accepted - CEP remains valid|08/04/2020
2577 Oxcarbazepine MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2013-181 - Rev 03 2025/09/16 Valid Chemical 2025/09/16 Notification|CEP granted|16/09/2025;
Notification|CEP granted|19/07/2024;
Notification|CEP granted|01/09/2021
549 Dexamethasone sodium phosphate CURIA SPAIN S.A.U. Boecillo ES 100011649;100019586 CEP 2008-026 - Rev 02 2025/09/16 Valid Chemical 2025/09/16 Minor revision|CEP granted|16/09/2025;
Minor revision|Accepted - CEP remains valid|16/09/2022;
Notification|CEP granted|24/08/2021

数据库说明:

当前数据更新日期:2026年05月28日。
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