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
394 Hydrochlorothiazide, Process I IPCA LABORATORIES LIMITED Mumbai IN R1-CEP 2004-013 - Rev 06 2023/08/29 Valid Chemical 2023/08/29 Minor revision|CEP granted|29/08/2023;
Major revision|CEP granted|06/12/2022;
Minor revision|CEP granted|27/07/2020
394 Hydrochlorothiazide CTX LIFESCIENCES PVT. LIMITED Surat IN R1-CEP 2008-021 - Rev 05 2023/08/29 Valid Chemical 2023/08/29 Minor revision|CEP granted|29/08/2023;
Minor revision|CEP granted|05/04/2023;
Minor revision|CEP granted|11/01/2022
1619 Magnesium pidolate Global Calcium Private Limited Hosur IN R1-CEP 2016-064 - Rev 01 2023/08/29 Valid Chemical 2023/08/29 Notification|CEP granted|29/08/2023;
Renewal|CEP granted|10/10/2022
2230 Latanoprost CAYMAN CHEMICAL COMPANY, INC. Ann Arbor US R0-CEP 2022-093 - Rev 00 2023/08/28 Valid 28/08/2028 Chemical 2024/05/13 Notification|Accepted - CEP remains valid|13/05/2024;
Minor revision|Accepted - CEP remains valid|09/11/2023;
New application|CEP granted|28/08/2023
2335 Ropivacaine hydrochloride monohydrate Chemwerth, Inc. Woodbridge US R0-CEP 2022-198 - Rev 00 2023/08/28 Valid 28/08/2028 Chemical 2023/08/28 New application|CEP granted|28/08/2023
892 Crospovidone, Type A and B BOAI NKY MEDICAL HOLDINGS LTD. Jiaozuo CN R0-CEP 2023-020 - Rev 00 2023/08/28 Valid 28/08/2028 Chemical 2023/08/28 New application|CEP granted|28/08/2023
2857 Trazodone hydrochloride, Process II AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A. Rome IT R0-CEP 2023-098 - Rev 00 2023/08/28 Valid 28/08/2028 Chemical 2024/03/20 Notification|Accepted - CEP remains valid|20/03/2024;
New application|CEP granted|28/08/2023
2779 Solifenacin succinate DELMAR CHEMICALS INC. LaSalle CA R1-CEP 2016-302 - Rev 00 2023/08/28 Valid Chemical 2023/08/28 Renewal|CEP granted|28/08/2023
1745 Carvedilol, Synthetic route B EGIS Pharmaceuticals PLC Budapest HU R1-CEP 2016-314 - Rev 00 2023/08/28 Valid Chemical 2023/08/28 Renewal|CEP granted|28/08/2023;
Major revision|CEP granted|02/08/2022;
Minor revision|CEP granted|26/08/2020
1558 Propofol EMCURE PHARMACEUTICALS LIMITED Pune IN R0-CEP 2020-203 - Rev 01 2023/08/25 Valid 05/01/2026 Chemical 2023/08/25 Notification|CEP granted|25/08/2023;
Major revision|Rejected|09/05/2023;
New application|CEP granted|05/01/2021
2898 Atazanavir sulfate SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO., LTD. Laogang Town CN R0-CEP 2021-115 - Rev 00 2023/08/25 Valid 25/08/2028 Chemical 2023/08/25 New application|CEP granted|25/08/2023
2778 Sitagliptin phosphate monohydrate CHEMO SMS ENTERPRISE, SL Madrid ES R0-CEP 2021-295 - Rev 00 2023/08/25 Valid 25/08/2028 Chemical 2023/08/25 New application|CEP granted|25/08/2023
1173 Benserazide hydrochloride Deva Holding A.Ş. Istanbul TR R0-CEP 2021-345 - Rev 00 2023/08/25 Valid 25/08/2028 Chemical 2023/08/25 New application|CEP granted|25/08/2023
3014 Rotigotine CHENGDU EASTON BIOPHARMACEUTICALS CO., LTD. Chengdu CN R0-CEP 2022-035 - Rev 00 2023/08/25 Valid 25/08/2028 Chemical 2023/08/25 New application|CEP granted|25/08/2023
1049 Threonine AMINO GMBH Frellstedt DE R1-CEP 2004-277 - Rev 03 2023/08/25 Valid Chemical 2023/08/25 Notification|CEP granted|25/08/2023;
Notification|Accepted - CEP remains valid|24/11/2022;
Minor revision|CEP granted|22/06/2020
1705 Sertraline hydrochloride, Form-I HETERO DRUGS LIMITED Hyderabad IN R1-CEP 2012-292 - Rev 02 2023/08/25 Valid Chemical 2023/08/25 Major revision|CEP granted|25/08/2023;
Minor revision|Accepted - CEP remains valid|09/04/2020
2114 Lysine acetate AMINO GMBH Frellstedt DE R1-CEP 2016-042 - Rev 01 2023/08/25 Valid Chemical 2023/08/25 Monograph revision|CEP granted|25/08/2023;
Renewal|CEP granted|15/07/2022
1322 Fenofibrate D.K. PHARMACHEM PVT. LTD. Badlapur IN R0-CEP 2020-213 - Rev 00 2023/08/24 Valid 24/08/2028 Chemical 2023/08/24 New application|CEP granted|24/08/2023
1075 Budesonide, Process II, micronised CIPLA LIMITED Mumbai IN R0-CEP 2023-094 - Rev 00 2023/08/24 Valid 24/08/2028 Chemical 2023/08/24 New application|CEP granted|24/08/2023
1181 Buprenorphine hydrochloride, Process II SPECGX LLC Webster Groves US R0-CEP 2023-107 - Rev 00 2023/08/24 Valid 24/08/2028 Chemical 2023/08/24 New application|CEP granted|24/08/2023

数据库说明:

当前数据更新日期:2024年08月17日。
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