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
2777 Pregabalin, ID 3636/9111 TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2020-375 - Rev 04 2026/04/09 Valid Chemical 2026/04/09 Renewal|CEP granted|09/04/2026;
Notification|CEP granted|14/03/2025;
Notification|CEP granted|08/02/2024;
Notification|CEP granted|20/12/2021;
New application|CEP granted|01/04/2021
2016 Ondansetron hydrochloride dihydrate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2004-042 - Rev 04 2026/04/09 Valid Chemical 2026/04/09 Minor revision|CEP granted|09/04/2026;
Notification|CEP granted|23/11/2021
1157 Tiaprofenic acid Erregierre S.p.A. San Paolo D'Argon IT 100012035;100021179 CEP 2024-355 - Rev 00 2026/04/09 Valid 09/04/2031 Chemical 2026/04/09 New application|CEP granted|09/04/2026
2114 Lysine acetate YICHANG SANXIA PROUDIN BIOPHARMACEUTICAL CO., LTD. Yichang CN 100041637;100068670 CEP 2025-057 - Rev 00 2026/04/09 Valid 09/04/2031 Chemical 2026/04/09 New application|CEP granted|09/04/2026
2191 Atorvastatin calcium, Process-IV ZYDUS LIFESCIENCES LIMITED Vadodara IN 100005979;100074301 CEP 2021-079 - Rev 04 2026/04/09 Valid Chemical 2026/04/09 Renewal|CEP granted|09/04/2026;
Minor revision|CEP granted|12/09/2025;
Minor revision|CEP granted|29/08/2024;
Monograph revision|CEP granted|01/08/2022;
New application|CEP granted|05/07/2021
1339 Levocarnitine ZHEJIANG BAMBOO PHARMACEUTICALS CO.,LTD. Shaoxing CN 100047946;100079294 CEP 2025-034 - Rev 00 2026/04/09 Valid 09/04/2031 Chemical 2026/04/09 New application|CEP granted|09/04/2026
924 Lactulose, liquid, 620 g/l LACTOSE (INDIA) LIMITED Mumbai IN 100055167;100098161 CEP 2025-451 - Rev 00 2026/04/09 Valid 09/04/2031 Chemical 2026/04/09 New application|CEP granted|09/04/2026
1606 Calcium levofolinate hydrate GMT FINE CHEMICALS S.A. Couvet CH 100019396;100028159 CEP 2008-320 - Rev 08 2026/04/08 Valid Chemical 2026/04/08 Minor revision|CEP granted|08/04/2026;
Minor revision|Accepted - CEP remains valid|17/10/2025;
Minor revision|Accepted - CEP remains valid|10/04/2025;
Notification|Accepted - CEP remains valid|17/10/2024;
Minor revision|CEP granted|27/02/2024;
Minor revision|Accepted - CEP remains valid|24/11/2022;
Major revision|CEP granted|18/03/2022;
Minor revision|CEP granted|14/01/2021
2423 Valsartan ZHUHAI RUNDU PHARMACEUTICAL CO., LTD. Zhuhai CN 100033558;100052545 CEP 2019-106 - Rev 03 2026/04/08 Valid Chemical 2026/04/08 Renewal|CEP granted|08/04/2026;
Minor revision|CEP granted|02/04/2024;
Minor revision|CEP granted|05/05/2022
217 Vitamin A, Not less than 2.8 MIU/g, acetate DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 2005-069 - Rev 03 2026/04/08 Valid Chemical 2026/04/08 Minor revision|CEP granted|08/04/2026;
Notification|CEP granted|18/07/2025;
Minor revision|CEP granted|12/07/2021
543 Carbamazepine JUBILANT BIOSYS LIMITED Mysuru IN 100055198;100098088 CEP 1999-109 - Rev 08 2026/04/08 Valid Chemical 2026/04/08 Minor revision|CEP granted|08/04/2026;
Notification|CEP granted|17/10/2025;
Notification|CEP granted|23/08/2022
1783 Glycopyrronium bromide OLON S.P.A. Rodano IT 100012085;100019537 CEP 2013-110 - Rev 05 2026/04/08 Valid Chemical 2026/04/08 Minor revision|CEP granted|08/04/2026;
Minor revision|CEP granted|23/08/2023;
Major revision|CEP granted|25/07/2022;
Minor revision|CEP granted|02/10/2020
333 Heparin sodium, For parenteral preparations NANJING KINGFRIEND BIOCHEMICAL PHARMACEUTICAL CO. LTD. Nanjing CN 100021124;100054143 CEP 2005-070 - Rev 12 2026/04/08 Valid Chemical 2026/04/08 Major revision|CEP granted|08/04/2026;
Monograph revision|Accepted - CEP remains valid|04/12/2025;
Notification|CEP granted|05/02/2025;
Monograph revision|Accepted - CEP remains valid|09/12/2024;
Notification|CEP granted|20/02/2024;
Minor revision|CEP granted|08/06/2023;
Notification|CEP granted|05/12/2022;
Notification|CEP granted|13/12/2021;
Minor revision|CEP granted|05/01/2021
2191 Atorvastatin calcium, TBAH Sulphate Route, VJ code APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2024-464 - Rev 01 2026/04/08 Valid 11/03/2031 Chemical 2026/04/08 Minor revision|CEP granted|08/04/2026;
New application|CEP granted|11/03/2026
2531 Clopidogrel hydrogen sulfate SANOFI WINTHROP INDUSTRIE Gentilly FR 100011564;100021551 CEP 2024-307 - Rev 00 2026/04/08 Valid 08/04/2031 Chemical 2026/04/08 New application|CEP granted|08/04/2026
2869 Fipronil for veterinary use NINGBO MENOVO PHARMACEUTICAL CO., LTD. Ningbo CN 100030313;100047776 CEP 2022-020 - Rev 02 2026/04/08 Valid 14/12/2027 Chemical 2026/04/08 Minor revision|CEP granted|08/04/2026;
Minor revision|CEP granted|15/11/2024;
New application|CEP granted|14/12/2022
1012 Famotidine ZYDUS LIFESCIENCES LIMITED Vadodara IN 100005979;100074301 CEP 2023-343 - Rev 00 2026/04/08 Valid 08/04/2031 Chemical 2026/04/08 New application|CEP granted|08/04/2026
2422 Oseltamivir phosphate BEIJING JINCHENG TAIER PHARMACEUTICAL CO., LTD. Beiwu Town CN 100049616;100085976 CEP 2023-418 - Rev 01 2026/04/08 Valid 25/07/2030 Chemical 2026/04/08 Minor revision|CEP granted|08/04/2026;
New application|CEP granted|25/07/2025
967 Acetylcysteine ZHEJIANG JINHUA CONBA BIO-PHARM. CO., LTD. Jinhua CN 100024897;100034088 CEP 2024-368 - Rev 00 2026/04/08 Valid 08/04/2031 Chemical 2026/04/08 New application|CEP granted|08/04/2026
1422 Etodolac, Standard and micronised ZHEJIANG BAMBOO PHARMACEUTICALS CO.,LTD. Shaoxing CN 100047946;100079294 CEP 2025-257 - Rev 00 2026/04/08 Valid 08/04/2031 Chemical 2026/04/08 New application|CEP granted|08/04/2026

数据库说明:

当前数据更新日期:2026年05月27日。
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