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
223 Ergometrine Maleate TAPI CZECH INDUSTRIES S.R.O. Opava CZ 100051642;100090678 CEP 2012-387 - Rev 03 2024/12/23 Valid Chemical 2024/12/23 Minor revision|CEP granted|23/12/2024;
Minor revision|CEP granted|09/12/2022;
Notification|Accepted - CEP remains valid|24/03/2021;
Monograph revision|CEP granted|21/04/2020
1008 Domperidone maleate, Process II SRI KRISHNA PHARMACEUTICALS LIMITED Hyderabad IN 100015104;100023787 CEP 2020-096 - Rev 01 2024/12/23 Valid 17/07/2028 Chemical 2024/12/23 Notification|CEP granted|23/12/2024;
New application|CEP granted|17/07/2023
1665 Betahistine dihydrochloride Laboratorios Espinos Y Bofill S.A. Cornella de Llobregat ES 100021595;100030302 CEP 2009-177 - Rev 03 2024/12/23 Valid Chemical 2024/12/23 Minor revision|CEP granted|23/12/2024
2992 Lacosamide, Form-I HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2018-099 - Rev 03 2024/12/23 Valid Chemical 2024/12/23 Renewal|CEP granted|23/12/2024;
Minor revision|Accepted - CEP remains valid|09/09/2022;
Major revision|CEP granted|03/11/2021;
Minor revision|Rejected|02/07/2021;
Minor revision|CEP granted|31/08/2020
2019 Perindopril tert-butylamine, PER55LP APOTEX PHARMACHEM INDIA PVT. LTD Bangalore IN 100012611;100041734 CEP 2019-196 - Rev 02 2024/12/23 Valid Chemical 2024/12/23 Renewal|CEP granted|23/12/2024;
Minor revision|CEP granted|21/08/2023
2258 Olanzapine, Form II Micronised TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL 100000702;100060842 CEP 2024-297 - Rev 00 2024/12/23 Valid 23/12/2029 Chemical 2024/12/23 New application|CEP granted|23/12/2024
914 Hydroxocobalamin chloride Hebei Huarong Pharmaceutical Co Ltd Xingtai CN 100020003;100061302 CEP 2023-256 - Rev 00 2024/12/23 Valid 23/12/2029 Chemical 2024/12/23 New application|CEP granted|23/12/2024
931 Metformin Hydrochloride, 2nd line NINGXIA HENGKANG TECHNOLOGY CO., LTD. Yinchuan CN 100049743;100086705 CEP 2024-237 - Rev 01 2024/12/23 Valid 02/08/2029 Chemical 2024/12/23 Minor revision|CEP granted|23/12/2024;
New application|CEP granted|02/08/2024
2932 Rivaroxaban MEHTA API PVT. LTD. Boisar IN 100020995;100042931 CEP 2022-212 - Rev 01 2024/12/23 Valid 30/05/2029 Chemical 2024/12/23 Minor revision|CEP granted|23/12/2024;
New application|CEP granted|30/05/2024
2932 Rivaroxaban, Micronised INDOCO REMEDIES LIMITED Mumbai IN 100020134;100061295 CEP 2022-159 - Rev 01 2024/12/23 Valid 26/06/2028 Chemical 2024/12/23 Minor revision|CEP granted|23/12/2024;
New application|CEP granted|26/06/2023
809 Betamethasone dipropionate SYMBIOTICA SPECIALITY INGREDIENTS SDN. BHD. Butterworth MY 100014908;100053188 CEP 2011-005 - Rev 02 2024/12/23 Valid Chemical 2024/12/23 Notification|CEP granted|23/12/2024
. Foetal Bovine Serum CAPRICORN SCIENTIFIC GMBH Ebsdorfergrund DE 100051998;100091460 CEP 2024-276 - Rev 00 2024/12/23 Valid 23/12/2029 TSE 2024/12/23 New application|CEP granted|23/12/2024
1354 Oxybutynin hydrochloride, Process II HARMAN FINOCHEM LIMITED Mumbai IN 100011528;100020515 CEP 2022-348 - Rev 01 2024/12/23 Valid 03/11/2027 Chemical 2024/12/23 Minor revision|CEP granted|23/12/2024;
New application|CEP granted|03/11/2022
2235 Methylphenidate hydrochloride JANSSEN PHARMACEUTICA NV Beerse BE 100000625;100005958 CEP 2009-219 - Rev 04 2024/12/23 Valid Chemical 2024/12/23 Notification|CEP granted|23/12/2024;
Notification|Accepted - CEP remains valid|18/01/2023;
Notification|CEP granted|13/01/2022;
Minor revision|CEP granted|15/12/2020
1009 Domperidone SRI KRISHNA PHARMACEUTICALS LIMITED Hyderabad IN 100015104;100023787 CEP 1997-094 - Rev 10 2024/12/20 Valid Chemical 2024/12/20 Notification|CEP granted|20/12/2024;
Monograph revision|Accepted - CEP remains valid|02/09/2022
1973 Cineole DÜLLBERG KONZENTRA GMBH & CO. KG Hamburg DE 100022402;100031085 CEP 2023-198 - Rev 01 2024/12/20 Valid 13/11/2029 Chemical 2024/12/20 Minor revision|CEP granted|20/12/2024;
New application|CEP granted|13/11/2024
1009 Domperidone, Process II SRI KRISHNA PHARMACEUTICALS LIMITED Hyderabad IN 100015104;100023787 CEP 2022-374 - Rev 01 2024/12/20 Valid 16/01/2028 Chemical 2024/12/20 Notification|CEP granted|20/12/2024;
New application|CEP granted|16/01/2023
1008 Domperidone maleate SRI KRISHNA PHARMACEUTICALS LIMITED Hyderabad IN 100015104;100023787 CEP 2003-069 - Rev 06 2024/12/20 Valid Chemical 2024/12/20 Notification|CEP granted|20/12/2024;
Monograph revision|CEP granted|10/10/2022;
Minor revision|CEP granted|30/04/2020
3095 Dabigatran etexilate mesilate, Crystalline Form-I, micronised and non-micronised MSN LIFE SCIENCES PRIVATE LIMITED Chandampet Village IN 100018316;100027671 CEP 2024-026 - Rev 00 2024/12/20 Valid 20/12/2029 Chemical 2024/12/20 New application|CEP granted|20/12/2024
2244 Tacrolimus monohydrate Chunghwa Chemical Synthesis & Biotech Co., Ltd. Shu-Lin TW 100011999;100018609 CEP 2018-241 - Rev 02 2024/12/20 Valid Chemical 2024/12/20 Renewal|CEP granted|20/12/2024;
Minor revision|CEP granted|30/03/2023;
Notification|Accepted - CEP remains valid|02/11/2020

数据库说明:

当前数据更新日期:2024年12月31日。
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