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
. Foetal Calf Serum, Defined, characterised, standard HYCLONE LABORATORIES LLC. Logan US 100012797;100022115 CEP 2000-076 - Rev 06 2025/05/07 Valid TSE 2025/05/07 Notification|CEP granted|07/05/2025;
Major revision|CEP granted|06/07/2022;
Notification|Rejected|25/03/2022;
Notification|Accepted - CEP remains valid|23/03/2021;
Notification|Accepted - CEP remains valid|27/08/2020;
Notification|CEP granted|24/06/2020
1705 Sertraline hydrochloride, Alternate process HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2012-218 - Rev 05 2025/05/07 Valid Chemical 2026/03/03 Notification|Accepted - CEP remains valid|03/03/2026;
Minor revision|CEP granted|07/05/2025;
Minor revision|Accepted - CEP remains valid|04/10/2023;
Minor revision|Accepted - CEP remains valid|17/02/2023;
Minor revision|CEP granted|07/09/2022
816 Cinnarizine FLEMING LABORATORIES LIMITED Nawabpet Village IN 100015641;100024384 CEP 2015-019 - Rev 01 2025/05/07 Valid Chemical 2025/05/07 Monograph revision|CEP granted|07/05/2025;
Renewal|CEP granted|10/05/2022;
Minor revision|Accepted - CEP remains valid|03/02/2021
888 Ciprofloxacin Hydrochloride, Process 105 ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD. Shaoxing CN 100022562;100093113 CEP 2019-007 - Rev 05 2025/05/07 Valid Chemical 2025/05/07 Renewal|CEP granted|07/05/2025;
Minor revision|CEP granted|29/10/2024;
Minor revision|CEP granted|26/06/2023;
Minor revision|CEP granted|16/08/2024;
Notification|Rejected|23/01/2023;
Minor revision|CEP granted|01/08/2022
2849 Hydroxychloroquine sulfate MANGALAM DRUGS & ORGANICS LTD. Mumbai IN 100012477;100021137 CEP 2019-151 - Rev 02 2025/05/07 Valid Chemical 2025/05/07 Renewal|CEP granted|07/05/2025;
Notification|CEP granted|19/07/2024
2600 Olmesartan medoxomil, Process II APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2020-112 - Rev 04 2025/05/07 Valid Chemical 2025/05/07 Renewal|CEP granted|07/05/2025;
Notification|CEP granted|11/01/2024;
Minor revision|CEP granted|05/06/2023;
Minor revision|CEP granted|19/08/2022;
New application|CEP granted|31/07/2020
1335 Itraconazole NOSCH LABS PRIVATE LIMITED Hyderabad IN 100020550;100029297 CEP 2011-283 - Rev 01 2025/05/05 Valid Chemical 2025/05/05 Minor revision|CEP granted|05/05/2025;
Minor revision|Rejected|21/02/2025
2126 Cefepime dihydrochloride monohydrate, Sterile QILU ANTIBIOTICS PHARMACEUTICAL CO. LTD. Jinan CN 100033695;100052910 CEP 2011-286 - Rev 02 2025/05/05 Valid Chemical 2025/05/05 Major revision|CEP granted|05/05/2025;
Major revision|CEP granted|21/12/2021
2306 Gemcitabine hydrochloride TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2008-161 - Rev 03 2025/05/05 Valid Chemical 2025/05/05 Notification|CEP granted|05/05/2025;
Notification|CEP granted|20/12/2021;
Notification|Accepted - CEP remains valid|22/02/2021
394 Hydrochlorothiazide TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2001-304 - Rev 13 2025/05/05 Valid Chemical 2025/05/05 Minor revision|CEP granted|05/05/2025;
Notification|Accepted - CEP remains valid|20/02/2023;
Minor revision|CEP granted|03/10/2022;
Minor revision|CEP granted|01/12/2021;
Minor revision|CEP granted|09/12/2020
1058 Vancomycin hydrochloride CHONGQING DAXIN PHARMACEUTICAL CO., LTD. Shuitu Town CN 100011996;100039007 CEP 2018-197 - Rev 01 2025/05/05 Valid Chemical and TSE 2025/05/05 Renewal|CEP granted|05/05/2025
1551 Nomegestrol acetate, Nomac grade B TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2014-178 - Rev 06 2025/05/05 Valid Chemical 2025/05/05 Minor revision|CEP granted|05/05/2025;
Minor revision|CEP granted|25/09/2024;
Notification|CEP granted|20/12/2021;
Minor revision|CEP granted|22/10/2021;
Minor revision|CEP granted|10/07/2020;
Monograph revision|CEP granted|06/05/2020
464 Amitriptyline hydrochloride, Process II DIPHARMA FRANCIS S.R.L. Baranzate IT 100014675;100030401 CEP 2019-193 - Rev 01 2025/05/05 Valid Chemical 2025/05/05 Renewal|CEP granted|05/05/2025
658 Chlorhexidine digluconate solution, CDG MEDICHEM, S.A. Sant Joan Despí ES 100001017;100002951 CEP 2017-128 - Rev 01 2025/05/05 Valid Chemical 2025/05/05 Minor revision|CEP granted|05/05/2025;
Monograph revision|Accepted - CEP remains valid|26/03/2025;
Minor revision|Accepted - CEP remains valid|13/07/2023;
Renewal|CEP granted|18/07/2022;
Notification|Accepted - CEP remains valid|10/06/2021;
Notification|Accepted - CEP remains valid|07/08/2020
396 Hydrogen peroxide solution (30 per cent) SOLVAY CHEMIE B.V. HERTEN NL 100024348;100033521 CEP 2018-167 - Rev 01 2025/05/05 Valid Chemical 2025/05/05 Renewal|CEP granted|05/05/2025;
Minor revision|Accepted - CEP remains valid|09/04/2024
2631 Rosuvastatin calcium ZHEJIANG LEPU PHARMACEUTICAL CO., LTD Taizhou City CN 100033518;100052465 CEP 2020-243 - Rev 01 2025/05/05 Valid 31/03/2027 Chemical 2025/05/05 Minor revision|CEP granted|05/05/2025;
New application|CEP granted|31/03/2022
2779 Solifenacin succinate DIJIA PHARMACEUTICAL GROUP CO., LTD. Weihai CN 100048717;100080764 CEP 2024-479 - Rev 00 2025/05/05 Valid 05/05/2030 Chemical 2025/05/05 New application|CEP granted|05/05/2025
931 Metformin Hydrochloride TRIMAX BIO SCIENCES PRIVATE LIMITED Raichur IN 100048452;100080257 CEP 2024-132 - Rev 00 2025/05/05 Valid 05/05/2030 Chemical 2025/05/05 New application|CEP granted|05/05/2025
67 Folic acid hydrate JIANGXI TIANXIN PHARMACEUTICAL CO., LTD. Leping CN 100016959;100025761 CEP 2022-378 - Rev 00 2025/05/05 Valid 05/05/2030 Chemical 2025/08/11 Minor revision|Accepted - CEP remains valid|11/08/2025;
New application|CEP granted|05/05/2025
2775 Nebivolol hydrochloride TORRENT PHARMACEUTICALS LIMITED Ahmedabad IN 100004452;100001862 CEP 2023-122 - Rev 01 2025/05/05 Valid 19/07/2029 Chemical 2025/05/05 Minor revision|CEP granted|05/05/2025;
New application|CEP granted|19/07/2024

数据库说明:

当前数据更新日期:2026年04月02日。
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