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
1449 Mometasone furoate SHANDONG SIRUI PHARMACEUTICAL CO., LTD. Heze CN 100049295;100083729 CEP 2024-044 - Rev 00 2025/06/27 Valid 27/06/2030 Chemical 2025/06/27 New application|CEP granted|27/06/2025
471 Calcitonin (salmon), Synthetic PIRAMAL PHARMA LIMITED Navi Mumbai IN 100036948;100075608 CEP 2012-236 - Rev 02 2025/06/25 Valid Chemical 2025/06/25 Minor revision|CEP granted|25/06/2025;
Notification|CEP granted|04/10/2022
2573 Candesartan cilexetil JIANGXI SYNERGY PHARMACEUTICAL CO., LTD. Yichun CN 100020812;100080065 CEP 2013-007 - Rev 05 2025/06/25 Valid Chemical 2025/06/25 Minor revision|CEP granted|25/06/2025;
Minor revision|CEP granted|28/08/2024;
Notification|CEP granted|20/09/2023;
Notification|CEP granted|21/03/2023;
Minor revision|Accepted - CEP remains valid|01/09/2021;
Minor revision|CEP granted|24/11/2020;
Notification|Abandoned|09/10/2020
2420 Tiotropium bromide monohydrate, Micronised, non-micronised VAMSI LABS LIMITED Solapur IN 100014747;100096958 CEP 2012-285 - Rev 03 2025/06/25 Valid Chemical 2025/06/25 Notification|CEP granted|25/06/2025;
Minor revision|CEP granted|16/01/2024;
Notification|Rejected|14/09/2023;
Notification|CEP granted|28/07/2022
946 Ranitidine hydrochloride, Crystalline powder grade and D.C. grade ORCHEV PHARMA PRIVATE LIMITED Rajkot IN 100020650;100029403 CEP 2007-320 - Rev 04 2025/06/25 Valid Chemical 2025/06/25 Administrative procedure|CEP granted|25/06/2025
1280 Zolpidem tartrate CENTAUR PHARMACEUTICALS PRIVATE LIMITED Mumbai IN 100018245;100028824 CEP 2002-171 - Rev 07 2025/06/25 Valid Chemical 2025/06/25 Minor revision|CEP granted|25/06/2025;
Notification|CEP granted|20/10/2023
1058 Vancomycin hydrochloride XELLIA PHARMACEUTICALS LTD. Budapest X HU 100012234;100020635 CEP 1999-110 - Rev 11 2025/06/25 Valid Chemical 2025/06/25 Minor revision|CEP granted|25/06/2025;
Minor revision|CEP granted|21/02/2023;
Notification|Accepted - CEP remains valid|11/01/2021
2582 Donepezil hydrochloride, Monohydrate NEULAND LABORATORIES LIMITED Hyderabad IN 100011545;100062134 CEP 2019-311 - Rev 02 2025/06/25 Valid 19/10/2026 Chemical 2025/12/02 Minor revision|Accepted - CEP remains valid|02/12/2025;
Minor revision|CEP granted|25/06/2025;
Minor revision|Accepted - CEP remains valid|12/12/2024;
Monograph revision|Accepted - CEP remains valid|13/12/2023;
Major revision|CEP granted|31/01/2024
1338 Lavender oil SCHWABE EXTRACTA GMBH & CO. KG Karlsruhe DE 100021578;100030272 CEP 2015-363 - Rev 02 2025/06/25 Valid Herbal 2025/06/25 Minor revision|CEP granted|25/06/2025;
Minor revision|CEP granted|05/06/2023;
Notification|Accepted - CEP remains valid|17/02/2023;
Renewal|CEP granted|13/09/2022;
Major revision|CEP granted|24/11/2021
1765 Salmeterol xinafoate, Micronised MELODY HEALTHCARE PRIVATE LIMITED Mumbai IN 100014822;100073679 CEP 2020-070 - Rev 02 2025/06/25 Valid Chemical 2025/06/25 Renewal|CEP granted|25/06/2025;
Minor revision|CEP granted|30/08/2021;
New application|CEP granted|14/08/2020
2219 Lansoprazole, Unit IV NOSCH LABS PRIVATE LIMITED Hyderabad IN 100020550;100029297 CEP 2020-185 - Rev 01 2025/06/25 Valid Chemical 2025/06/25 Renewal|CEP granted|25/06/2025;
New application|CEP granted|26/08/2020
2609 Triclabendazole for veterinary use ALIVIRA ANIMAL HEALTH LIMITED Visakhapatnam IN 100033528;100052489 CEP 2015-109 - Rev 03 2025/06/25 Valid Chemical 2025/06/25 Minor revision|CEP granted|25/06/2025;
Major revision|CEP granted|03/07/2023;
Minor revision|CEP granted|08/07/2022;
Renewal|CEP granted|18/03/2022
2931 Sorafenib tosilate SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN 100044578;100073706 CEP 2022-056 - Rev 01 2025/06/25 Valid 10/06/2029 Chemical 2025/06/25 Monograph revision|CEP granted|25/06/2025;
New application|CEP granted|10/06/2024
576 Allopurinol HENAN DONGTAI PHARM CO., LTD. Anyang CN 100023192;100052097 CEP 2023-232 - Rev 00 2025/06/25 Valid 25/06/2030 Chemical 2025/06/25 New application|CEP granted|25/06/2025
1706 Thiamazole MAITHRI DRUGS PRIVATE LIMITED Bonthapally Village IN 100020971;100029680 CEP 2022-029 - Rev 02 2025/06/25 Valid 28/09/2028 Chemical 2025/06/25 Monograph revision|CEP granted|25/06/2025;
Minor revision|CEP granted|14/05/2024;
New application|CEP granted|28/09/2023
635 Primaquine diphosphate, PQ3 Process IPCA LABORATORIES LIMITED Mumbai IN 100011685;100018680 CEP 2022-258 - Rev 01 2025/06/25 Valid 23/06/2028 Chemical 2025/06/25 Minor revision|CEP granted|25/06/2025;
New application|CEP granted|23/06/2023
1393 Benzbromarone ZHEJIANG CHEMSYN PHARM. CO., LTD. Quzhou CN 100025798;100035044 CEP 2023-109 - Rev 00 2025/06/25 Valid 25/06/2030 Chemical 2025/06/25 New application|CEP granted|25/06/2025
1790 Naltrexone hydrochloride, Process 2 SANECA PHARMACEUTICALS A.S. Hlohovec SK 100002257;100000752 CEP 2025-194 - Rev 00 2025/06/25 Valid 25/06/2030 Chemical 2025/06/25 New application|CEP granted|25/06/2025
2192 Atovaquone, Form A, Process-II HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2025-001 - Rev 00 2025/06/25 Valid 25/06/2030 Chemical 2025/06/25 New application|CEP granted|25/06/2025
2735 Gadobutrol monohydrate MSN LIFE SCIENCES PRIVATE LIMITED Bhiknoor Village IN 100018316;100070723 CEP 2023-260 - Rev 00 2025/06/25 Valid 25/06/2030 Chemical 2025/06/25 New application|CEP granted|25/06/2025

数据库说明:

当前数据更新日期:2026年02月12日。
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