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
2857 Trazodone hydrochloride PIRAMAL PHARMA LIMITED Digwal Village IN 100036948;100058375 CEP 2022-166 - Rev 02 2025/01/29 Valid 01/08/2028 Chemical 2025/01/29 Administrative procedure|CEP granted|29/01/2025;
Notification|CEP granted|20/01/2025;
New application|CEP granted|01/08/2023
1199 Dipyridamole SOCIETÀ ITALIANA MEDICINALI SCANDICCI S.I.M.S. S.R.L Reggello IT 100012503;100022784 CEP 2004-204 - Rev 04 2025/01/27 Valid Chemical 2025/01/27 Minor revision|CEP granted|27/01/2025;
Notification|Rejected|25/09/2023
260 Amoxicillin trihydrate, Micronised, normal and high density powder ZHUHAI UNITED LABORATORIES CO., LTD. Sanzao Town CN 100022945;100052547 CEP 2006-039 - Rev 03 2025/01/27 Valid Chemical 2025/01/27 Notification|CEP granted|27/01/2025;
Notification|Accepted - CEP remains valid|13/06/2024;
Minor revision|CEP granted|16/10/2020
2125 Doxazosin mesilate, Form-II CHEMISCHE FABRIK BERG GMBH Bitterfeld-Wolfen DE 100014200;100020038 CEP 2024-489 - Rev 00 2025/01/27 Valid 27/01/2030 Chemical 2025/01/27 New application|CEP granted|27/01/2025
2573 Candesartan cilexetil, Form I TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2011-248 - Rev 03 2025/01/27 Valid Chemical 2025/01/27 Notification|CEP granted|27/01/2025;
Notification|Accepted - CEP remains valid|04/12/2023;
Notification|CEP granted|22/11/2021
2631 Rosuvastatin calcium, Process-III, Amorphous BIOCON LIMITED Bengaluru IN 100011487;100018595 CEP 2024-354 - Rev 00 2025/01/24 Valid 24/01/2030 Chemical 2025/01/24 New application|CEP granted|24/01/2025
2933 Deferasirox TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2021-111 - Rev 01 2025/01/24 Valid 11/04/2028 Chemical 2025/01/24 Notification|CEP granted|24/01/2025;
Minor revision|Accepted - CEP remains valid|10/07/2024;
Notification|Accepted - CEP remains valid|02/10/2023;
New application|CEP granted|11/04/2023
2011 Calcipotriol CHONGQING HUAPONT SHENGCHEM PHARMACEUTICAL CO., LTD. Chongqing CN 100024073;100062002 CEP 2024-219 - Rev 00 2025/01/24 Valid 24/01/2030 Chemical 2025/01/24 New application|CEP granted|24/01/2025
2449 Docetaxel trihydrate FRESENIUS KABI ONCOLOGY LIMITED Kalyani IN 100011513;100018607 CEP 2011-189 - Rev 05 2025/01/24 Valid Chemical 2025/01/24 Major revision|CEP granted|24/01/2025;
Minor revision|Accepted - CEP remains valid|22/08/2024;
Notification|Accepted - CEP remains valid|18/08/2023;
Minor revision|CEP granted|16/02/2023;
Notification|Rejected|12/01/2023;
Minor revision|CEP granted|07/02/2022;
Notification|CEP granted|16/12/2020
668 Flucloxacillin sodium monohydrate, Powder and compacted FRESENIUS KABI IPSUM S.R.L. Cassina de’ Pecchi IT 100015105;100057989 CEP 1996-054 - Rev 11 2025/01/24 Valid Chemical 2025/01/24 Minor revision|CEP granted|24/01/2025;
Monograph revision|CEP granted|18/05/2022;
Notification|CEP granted|11/02/2021
989 Cefotaxime sodium, Sterile NECTAR LIFESCIENCES LIMITED Tehsil Dera Bassi IN 100019097;100029430 CEP 2011-226 - Rev 01 2025/01/23 Suspended by EDQM GMP non-compliance 2025/04/07 Chemical 2025/01/23 Minor revision|CEP granted|23/01/2025
455 Citric acid, non-micronised and micronised JUNGBUNZLAUER LADENBURG GMBH Ladenburg DE 100014785;100073136 CEP 2016-005 - Rev 03 2025/01/23 Valid Chemical 2025/09/19 Minor revision|Accepted - CEP remains valid|19/09/2025;
Administrative procedure|CEP granted|23/01/2025;
Minor revision|CEP granted|03/01/2025;
Notification|CEP granted|28/08/2024;
Renewal|CEP granted|18/07/2022;
Notification|Accepted - CEP remains valid|08/01/2021
2406 Anastrozole TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2014-099 - Rev 02 2025/01/23 Valid Chemical 2025/08/29 Minor revision|Accepted - CEP remains valid|29/08/2025;
Notification|CEP granted|23/01/2025;
Minor revision|Accepted - CEP remains valid|14/06/2024;
Minor revision|Accepted - CEP remains valid|28/10/2022;
Notification|CEP granted|20/12/2021;
Renewal|CEP granted|16/07/2020
906 Glipizide SRI KRISHNA PHARMACEUTICALS LIMITED Hyderabad IN 100015104;100023787 CEP 2014-070 - Rev 01 2025/01/23 Valid Chemical 2025/01/23 Minor revision|CEP granted|23/01/2025;
Renewal|CEP granted|25/03/2021
2423 Valsartan, Micronised and non-micronised MSN LIFE SCIENCES PRIVATE LIMITED Chandampet Village IN 100018316;100027671 CEP 2018-275 - Rev 04 2025/01/23 Valid Chemical 2025/01/23 Renewal|CEP granted|23/01/2025;
Minor revision|CEP granted|24/08/2023;
Minor revision|CEP granted|18/11/2022;
Minor revision|CEP granted|24/09/2021
2582 Donepezil hydrochloride, Monohydrate SYNTHIMED LABS PRIVATE LIMITED Derabassi IN 100052287;100092080 CEP 2021-116 - Rev 03 2025/01/23 Valid 19/10/2027 Chemical 2025/01/23 Minor revision|CEP granted|23/01/2025;
Minor revision|CEP granted|05/09/2024;
Monograph revision|CEP granted|15/12/2023;
New application|CEP granted|19/10/2022
2573 Candesartan cilexetil, Form I - process 2 TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2020-164 - Rev 02 2025/01/23 Valid Chemical 2025/09/15 Renewal|Accepted - CEP remains valid|15/09/2025;
Notification|CEP granted|23/01/2025;
Notification|Accepted - CEP remains valid|04/12/2023;
Notification|Accepted - CEP remains valid|01/04/2022;
Notification|CEP granted|22/11/2021;
New application|CEP granted|10/11/2020
2849 Hydroxychloroquine sulfate PORTON PHARMA SOLUTIONS LTD. Changshou CN 100018751;100027547 CEP 2022-416 - Rev 00 2025/01/23 Valid 23/01/2030 Chemical 2025/10/13 Notification|Accepted - CEP remains valid|13/10/2025;
New application|CEP granted|23/01/2025
937 Minoxidil SONIA ORGANICS Bengaluru IN 100046888;100077397 CEP 2022-331 - Rev 00 2025/01/23 Valid 23/01/2030 Chemical 2025/01/23 New application|CEP granted|23/01/2025
2119 Venlafaxine hydrochloride ATUL BIOSCIENCE LIMITED Ambernath (East) IN 100044514;100086818 CEP 2022-447 - Rev 01 2025/01/23 Valid 24/04/2029 Chemical 2025/01/23 Minor revision|CEP granted|23/01/2025;
New application|CEP granted|24/04/2024

数据库说明:

当前数据更新日期:2025年12月06日。
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