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
2258 Olanzapine, Form-I LEE PHARMA LIMITED Hyderabad IN 100014849;100042625 CEP 2017-020 - Rev 01 2026/03/19 Valid Chemical 2026/03/19 Minor revision|CEP granted|19/03/2026;
Minor revision|Rejected|24/10/2025;
Renewal|CEP granted|22/05/2023;
Major revision|CEP granted|15/03/2023
2223 Glimepiride HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2007-156 - Rev 05 2026/03/19 Valid Chemical 2026/03/19 Minor revision|CEP granted|19/03/2026;
Notification|Accepted - CEP remains valid|25/10/2024;
Notification|Accepted - CEP remains valid|15/12/2023;
Minor revision|Accepted - CEP remains valid|23/11/2021
454 Acetazolamide EMCURE PHARMACEUTICALS LIMITED Pune IN 100011677;100099996 CEP 2018-203 - Rev 03 2026/03/19 Valid Chemical 2026/03/19 Minor revision|CEP granted|19/03/2026;
Renewal|CEP granted|26/02/2025;
Minor revision|CEP granted|27/11/2023;
Minor revision|Accepted - CEP remains valid|13/01/2022
931 Metformin Hydrochloride, 2nd line NINGXIA HENGKANG TECHNOLOGY CO., LTD. Yinchuan CN 100049743;100086705 CEP 2024-237 - Rev 03 2026/03/19 Valid 02/08/2029 Chemical 2026/03/19 Major revision|CEP granted|19/03/2026;
Major revision|CEP granted|14/08/2025;
Minor revision|CEP granted|23/12/2024;
New application|CEP granted|02/08/2024
335 Hydrocortisone HENAN LIHUA PHARMACEUTICAL CO., LTD. Anyang CN 100016183;100024971 CEP 2022-264 - Rev 01 2026/03/19 Valid 22/08/2028 Chemical 2026/03/19 Minor revision|CEP granted|19/03/2026;
New application|CEP granted|22/08/2023
2254 Moxifloxacin hydrochloride HEC PHARM GMBH Berlin DE 100002583;100098718 CEP 2013-225 - Rev 04 2026/03/19 Valid Chemical 2026/03/19 Notification|CEP granted|19/03/2026;
Administrative procedure|CEP granted|03/12/2024;
Minor revision|CEP granted|05/08/2024;
Minor revision|CEP granted|26/08/2021
. Collagen GUANGZHOU TRAUER BIOTECHNOLOGY CO., LTD. Guangzhou CN 100055483;100098662 CEP 2025-482 - Rev 00 2026/03/17 Valid 17/03/2031 TSE 2026/03/19 New application|CEP granted|19/03/2026
285 Noradrenaline tartrate MOEHS IBERICA S.L. Rubi ES 100029092;100068825 CEP 2024-532 - Rev 00 2026/03/17 Valid 17/03/2031 Chemical 2026/03/19 New application|CEP granted|19/03/2026
3095 Dabigatran etexilate mesilate, Form-I PIRAMAL PHARMA LIMITED Digwal Village IN 100036948;100058375 CEP 2024-090 - Rev 00 2026/03/17 Valid 17/03/2031 Chemical 2026/03/19 New application|CEP granted|19/03/2026
655 Camphor, racemic SAPTAGIR LABORATORIES PRIVATE LIMITED Hyderabad IN 100042587;100070387 CEP 2023-320 - Rev 00 2026/03/17 Valid 17/03/2031 Chemical 2026/03/19 New application|CEP granted|19/03/2026
1386 Albendazole MAHI DRUGS PRIVATE LIMITED Hyderabad IN 100048039;100079525 CEP 2023-415 - Rev 00 2026/03/17 Valid 17/03/2031 Chemical 2026/03/19 New application|CEP granted|19/03/2026
2217 Lamivudine SMS PHARMACEUTICALS LIMITED Hyderabad IN 100011780;100061058 CEP 2023-425 - Rev 00 2026/03/17 Valid 17/03/2031 Chemical 2026/03/19 New application|CEP granted|19/03/2026
1467 Prednicarbate SYMBIOTICA SPECIALITY INGREDIENTS SDN. BHD. Butterworth MY 100014908;100053188 CEP 2024-038 - Rev 00 2026/03/17 Valid 17/03/2031 Chemical 2026/03/19 New application|CEP granted|19/03/2026
2589 Abacavir sulfate VIYASH LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100040217;100065484 CEP 2025-454 - Rev 00 2026/03/17 Valid 17/03/2031 Chemical 2026/03/19 New application|CEP granted|19/03/2026
2598 Levofloxacin hemihydrate SCL LIFESCIENCES LIMITED Sahibzada Ajit Singh Nagar IN 100011774;100018647 CEP 2019-315 - Rev 02 2026/03/17 Valid 18/05/2027 Chemical 2026/03/19 Minor revision|CEP granted|19/03/2026;
Notification|CEP granted|14/03/2025;
Minor revision|Accepted - CEP remains valid|28/05/2024;
Minor revision|Accepted - CEP remains valid|12/06/2023
2775 Nebivolol hydrochloride LUSOCHIMICA S.P.A. Casaletto Lodigiano IT 100014864;100023519 CEP 2023-063 - Rev 02 2026/03/17 Valid 03/04/2029 Chemical 2026/03/19 Notification|CEP granted|19/03/2026;
Notification|CEP granted|30/07/2024;
New application|CEP granted|03/04/2024
2287 Fluconazole, Process II ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2009-226 - Rev 05 2026/03/17 Valid Chemical 2026/03/19 Monograph revision|CEP granted|19/03/2026;
Notification|CEP granted|04/04/2025;
Minor revision|CEP granted|09/01/2025;
Notification|CEP granted|06/12/2022
2215 Iodixanol ZHEJIANG HAIZHOU PHARMACEUTICAL CO., LTD. Linhai CN 100023844;100033013 CEP 2025-035 - Rev 00 2026/03/17 Valid 17/03/2031 Chemical 2026/03/19 New application|CEP granted|19/03/2026
1456 Olive oil, refined, BXR EU refined olive oil SOCIETE INDUSTRIELLE DES OLEAGINEUX SIO Saint Laurent Blangy FR 100018152;100094230 CEP 2012-333 - Rev 02 2026/03/13 Valid Chemical 2026/03/13 Administrative procedure|CEP granted|13/03/2026;
Minor revision|Accepted - CEP remains valid|30/10/2025;
Notification|CEP granted|17/01/2025;
Minor revision|Accepted - CEP remains valid|27/08/2024;
Minor revision|Accepted - CEP remains valid|09/03/2022;
Minor revision|Accepted - CEP remains valid|06/07/2020
2258 Olanzapine TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2012-161 - Rev 05 2026/03/13 Valid Chemical 2026/03/13 Minor revision|CEP granted|13/03/2026;
Minor revision|Accepted - CEP remains valid|30/04/2025;
Notification|Rejected|15/04/2025;
Notification|CEP granted|19/03/2025;
Notification|CEP granted|15/04/2024;
Minor revision|CEP granted|04/01/2022;
Administrative procedure|CEP granted|12/08/2020;
Notification|Abandoned|05/08/2020

数据库说明:

当前数据更新日期:2026年04月02日。
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