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
931 Metformin Hydrochloride SHANDONG SHOUGUANG BOKANG PHARMACEUTICAL CO., LTD. Yangkou Town CN 100048458;100080267 CEP 2019-141 - Rev 01 2025/12/12 Valid Chemical 2025/12/12 Renewal|CEP granted|12/12/2025;
Minor revision|Rejected|16/08/2022
2306 Gemcitabine hydrochloride HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2009-208 - Rev 03 2025/12/12 Valid Chemical 2025/12/12 Minor revision|CEP granted|12/12/2025;
Minor revision|Accepted - CEP remains valid|30/01/2024;
Minor revision|Accepted - CEP remains valid|19/04/2022;
Minor revision|Accepted - CEP remains valid|02/02/2022;
Minor revision|CEP granted|02/11/2020
1454 Nonoxinol 9 SYENSQO USA LLC Spartanburg US 100038993;100061359 CEP 2007-327 - Rev 02 2025/12/12 Valid Chemical 2025/12/12 Notification|CEP granted|12/12/2025;
Minor revision|CEP granted|04/05/2022;
Notification|Rejected|21/03/2022
534 Trimipramine maleate LUNDBECK PHARMACEUTICALS ITALY S.P.A. Padova IT 100005981;100005944 CEP 2011-329 - Rev 01 2025/12/12 Valid Chemical 2025/12/12 Minor revision|CEP granted|12/12/2025;
Minor revision|Accepted - CEP remains valid|26/08/2024
1559 Risperidone CHIERON ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN 100053345;100094249 CEP 2018-210 - Rev 02 2025/12/12 Valid Chemical 2025/12/12 Renewal|CEP granted|12/12/2025;
Notification|CEP granted|17/06/2025
2362 Rifaximin LUOHE CHIEF PHARMACEUTICAL CO., LTD. Luohe City CN 100043312;100071644 CEP 2021-420 - Rev 01 2025/12/12 Valid 06/06/2028 Chemical 2025/12/12 Major revision|CEP granted|12/12/2025;
New application|CEP granted|06/06/2023
2932 Rivaroxaban, Process-2, Symed Labs Limited Unit-I, 1RVS SYMED LABS LIMITED Hyderabad IN 100018727;100090820 CEP 2025-385 - Rev 00 2025/12/12 Valid 12/12/2030 Chemical 2025/12/12 New application|CEP granted|12/12/2025
566 Penicillamine FLEMING LABORATORIES LIMITED Hyderabad IN 100015641;100067279 CEP 2022-136 - Rev 01 2025/12/12 Valid 17/06/2029 Chemical 2025/12/12 Minor revision|CEP granted|12/12/2025;
New application|CEP granted|17/06/2024
. Purified bovine Haemoglobin SOUTH PACIFIC SERA LIMITED Timaru NZ 100044527;100099043 CEP 2025-262 - Rev 00 2025/12/12 Valid 12/12/2030 TSE 2025/12/12 New application|CEP granted|12/12/2025
1758 Moxonidine MICRO LABS LIMITED Bengaluru IN 100017819;100077269 CEP 2025-322 - Rev 00 2025/12/12 Valid 12/12/2030 Chemical 2025/12/12 New application|CEP granted|12/12/2025
2768 Fluticasone furoate, Micronised AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN 100045727;100075371 CEP 2024-361 - Rev 00 2025/12/12 Valid 12/12/2030 Chemical 2025/12/12 New application|CEP granted|12/12/2025
2760 Brimonidine tartrate SYMED LABS LIMITED Hyderabad IN 100018727;100090820 CEP 2018-124 - Rev 01 2025/12/11 Valid Chemical 2025/12/11 Renewal|CEP granted|11/12/2025
2307 Modafinil ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 CEP 2014-073 - Rev 01 2025/12/11 Valid Chemical 2025/12/11 Minor revision|CEP granted|11/12/2025;
Minor revision|Accepted - CEP remains valid|06/07/2022;
Renewal|CEP granted|14/01/2021
2064 Chondroitin sulfate sodium, Process A and B BIOIBERICA, S.A.U. Palafolls ES 100000136;100043853 CEP 2001-063 - Rev 07 2025/12/11 Valid TSE 2025/12/11 Minor revision|CEP granted|11/12/2025;
Minor revision|CEP granted|26/10/2022;
Major revision|CEP granted|24/03/2022
1012 Famotidine GEDEON RICHTER PLC. Budapest HU 100000640;100001653 CEP 1999-054 - Rev 04 2025/12/11 Valid Chemical 2025/12/11 Minor revision|CEP granted|11/12/2025;
Minor revision|CEP granted|18/02/2022
601 Dimenhydrinate SHANGHAI WONDER PHARMACEUTICAL CO., LTD Shanghai CN 100020697;100029440 CEP 2020-110 - Rev 02 2025/12/11 Valid 03/03/2027 Chemical 2025/12/11 Minor revision|CEP granted|11/12/2025;
Notification|Accepted - CEP remains valid|07/07/2025;
Minor revision|CEP granted|15/02/2024;
New application|CEP granted|03/03/2022
1648 Thioctic acid CADCHEM LABORATORIES LIMITED Chandigarh IN 100039011;100083960 CEP 2024-419 - Rev 00 2025/12/11 Valid 11/12/2030 Chemical 2025/12/11 New application|CEP granted|11/12/2025
1648 Thioctic acid KINSY S.L. Murcia ES 100025606;100057039 CEP 2024-321 - Rev 00 2025/12/11 Valid 11/12/2030 Chemical 2025/12/11 New application|CEP granted|11/12/2025
2445 Adapalene MAITHRI DRUGS PRIVATE LIMITED Bonthapally Village IN 100020971;100029680 CEP 2023-462 - Rev 00 2025/12/11 Valid 11/12/2030 Chemical 2025/12/11 New application|CEP granted|11/12/2025
1699 Mesalazine, Pubagang site ZHEJIANG HENGKANG PHARMACEUTICAL CO., LTD. Sanmen CN 100034135;100082085 CEP 2021-400 - Rev 01 2025/12/10 Valid 17/12/2026 Chemical 2025/12/10 Minor revision|CEP granted|10/12/2025;
Minor revision|Accepted - CEP remains valid|04/10/2024;
New application|CEP granted|17/12/2021

数据库说明:

当前数据更新日期:2025年12月14日。
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