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
1200 Dobutamine hydrochloride BIOINDUSTRIA L.I.M. S.P.A. Novi Ligure IT 100001870;100092872 CEP 2004-261 - Rev 02 2025/08/14 Valid Chemical 2025/08/14 Minor revision|CEP granted|14/08/2025
3132 Mirabegron BIOCON LIMITED Bengaluru IN 100011487;100018595 CEP 2023-460 - Rev 00 2025/08/14 Valid 14/08/2030 Chemical 2025/08/14 New application|CEP granted|14/08/2025
1983 Josamycin MICROBIOPHARM JAPAN CO., LTD. Tokyo JP 100012325;100088928 CEP 2021-502 - Rev 02 2025/08/14 Valid 29/06/2028 Chemical 2025/08/14 Minor revision|CEP granted|14/08/2025;
Minor revision|CEP granted|01/07/2024;
New application|CEP granted|29/06/2023
369 Azathioprine RPG LIFE SCIENCES LIMITED Navi Mumbai IN 100017119;100025920 CEP 2001-341 - Rev 11 2025/08/14 Valid Chemical 2025/08/14 Minor revision|CEP granted|14/08/2025;
Notification|CEP granted|12/04/2024;
Minor revision|CEP granted|14/03/2024;
Minor revision|CEP granted|22/08/2022
106 Hyoscine hydrobromide ALKALOIDS PRIVATE LIMITED Secunderabad IN 100021602;100041426 CEP 2019-152 - Rev 02 2025/08/14 Valid Chemical 2025/08/14 Renewal|CEP granted|14/08/2025;
Transfer of holdership|CEP granted|11/12/2023
931 Metformin Hydrochloride, 2nd line NINGXIA HENGKANG TECHNOLOGY CO., LTD. Yinchuan CN 100049743;100086705 CEP 2024-237 - Rev 02 2025/08/14 Valid 02/08/2029 Chemical 2025/08/14 Major revision|CEP granted|14/08/2025;
Minor revision|CEP granted|23/12/2024;
New application|CEP granted|02/08/2024
829 Hydralazine hydrochloride D. K. PHARMA CHEM PRIVATE LIMITED Badlapur IN 100023552;100032697 CEP 2023-431 - Rev 00 2025/08/14 Valid 14/08/2030 Chemical 2025/08/14 New application|CEP granted|14/08/2025
1084 Cetirizine dihydrochloride IPCA LABORATORIES LIMITED Mumbai IN 100011685;100018680 CEP 2006-309 - Rev 02 2025/08/13 Valid Chemical 2025/08/13 Minor revision|CEP granted|13/08/2025;
Notification|Accepted - CEP remains valid|23/06/2023
1519 Flurbiprofen, Process 3 FDC Limited Mumbai IN 100011646;100021030 CEP 2025-225 - Rev 00 2025/08/13 Valid 13/08/2030 Chemical 2025/08/13 New application|CEP granted|13/08/2025
1764 Rocuronium bromide MANKIND PHARMA LIMITED New Delhi IN 100040218;100065486 CEP 2024-337 - Rev 00 2025/08/13 Valid 13/08/2030 Chemical 2025/08/13 New application|CEP granted|13/08/2025
199 Oxytetracycline dihydrate INNER MONGOLIA HUASHU BIOLOGICAL TECHNOLOGY CO.LTD Tongliao City CN 100052898;100093261 CEP 2018-238 - Rev 01 2025/08/13 Valid Chemical 2025/08/13 Renewal|CEP granted|13/08/2025
1450 Mupirocin, Process B FUJIAN COMHONY BIOTECHNOLOGY CO., LTD. Fuqing CN 100043888;100072481 CEP 2022-391 - Rev 01 2025/08/13 Valid 29/11/2028 Chemical and TSE 2025/08/13 Minor revision|CEP granted|13/08/2025;
New application|CEP granted|29/11/2023
2223 Glimepiride MSN LIFE SCIENCES PRIVATE LIMITED Bhiknoor Village IN 100018316;100070723 CEP 2022-111 - Rev 01 2025/08/12 Valid 05/07/2029 Chemical 2025/08/12 Minor revision|CEP granted|12/08/2025;
New application|CEP granted|05/07/2024
1705 Sertraline hydrochloride, Process IVB SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2017-264 - Rev 01 2025/08/12 Valid Chemical 2025/08/12 Minor revision|CEP granted|12/08/2025;
Renewal|CEP granted|05/05/2023;
Minor revision|Accepted - CEP remains valid|07/06/2022;
Minor revision|Accepted - CEP remains valid|24/02/2022;
Administrative procedure|CEP granted|10/11/2021;
Major revision|CEP granted|25/10/2021;
Notification|CEP granted|30/03/2021;
Minor revision|Accepted - CEP remains valid|05/03/2021;
Notification|Accepted - CEP remains valid|02/12/2020;
Notification|Accepted - CEP remains valid|24/04/2020
1058 Vancomycin hydrochloride, Precipitated LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN 100020920;100029633 CEP 2012-235 - Rev 04 2025/08/12 Valid Chemical 2025/08/12 Administrative procedure|CEP granted|12/08/2025;
Minor revision|CEP granted|25/07/2025;
Monograph revision|CEP granted|28/10/2024;
Notification|Accepted - CEP remains valid|06/06/2024;
Minor revision|CEP granted|31/03/2023;
Minor revision|Rejected|13/01/2023;
Notification|Accepted - CEP remains valid|27/05/2021
2778 Sitagliptin phosphate monohydrate, Process II ZHEJIANG JINGSHENG PHARMACEUTICAL CO., LTD. Taizhou City CN 100048181;100079705 CEP 2023-453 - Rev 01 2025/08/12 Valid 06/05/2029 Chemical 2025/08/12 Transfer of holdership|CEP granted|12/08/2025;
New application|CEP granted|06/05/2024
2423 Valsartan NINGBO MENOVO PHARMACEUTICAL CO., LTD. Ningbo CN 100030313;100047776 CEP 2019-258 - Rev 02 2025/08/12 Valid 05/02/2026 Chemical 2025/08/12 Minor revision|CEP granted|12/08/2025;
Major revision|CEP granted|09/07/2024;
Minor revision|Accepted - CEP remains valid|13/10/2022;
Notification|Accepted - CEP remains valid|01/12/2021;
Minor revision|Accepted - CEP remains valid|25/06/2021
1734 Terbinafine hydrochloride APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2007-146 - Rev 08 2025/08/11 Valid Chemical 2025/08/11 Minor revision|CEP granted|11/08/2025;
Minor revision|Accepted - CEP remains valid|21/06/2024;
Notification|CEP granted|05/03/2024;
Notification|CEP granted|13/12/2023;
Notification|Accepted - CEP remains valid|20/12/2022;
Minor revision|CEP granted|14/08/2020
721 Ibuprofen HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO., LTD. Jingmen City CN 100020377;100029131 CEP 2002-099 - Rev 08 2025/08/11 Valid Chemical 2025/08/11 Minor revision|CEP granted|11/08/2025;
Minor revision|Accepted - CEP remains valid|04/05/2023;
Notification|CEP granted|07/12/2020;
Notification|CEP granted|07/08/2020
2338 Mirtazapine APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2007-062 - Rev 05 2025/08/11 Valid Chemical 2025/08/11 Minor revision|CEP granted|11/08/2025;
Notification|CEP granted|13/12/2023;
Minor revision|Accepted - CEP remains valid|20/02/2020

数据库说明:

当前数据更新日期:2025年08月19日。
©2006-2025 DrugFuture->Certificates of Suitability to the monographs of European Pharmacopoeia, EDQM