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 MSN LIFE SCIENCES PRIVATE LIMITED Medak IN 100018316;100027671 CEP 2024-535 - Rev 00 2026/04/08 Valid 08/04/2031 Chemical 2026/04/08 New application|CEP granted|08/04/2026
2191 Atorvastatin calcium, Trihydrate, process II MANKIND PHARMA LIMITED New Delhi IN 100040218;100065486 CEP 2025-580 - Rev 00 2026/04/08 Valid 08/04/2031 Chemical 2026/04/08 New application|CEP granted|08/04/2026
708 Cefalexin monohydrate, Enzymatic ACS DOBFAR S.P.A. Tribiano IT 100011589;100019524 CEP 2025-569 - Rev 00 2026/04/08 Valid 08/04/2031 Chemical 2026/04/08 New application|CEP granted|08/04/2026
1142 Povidone, iodinated SYNVENT NINGXIA CO.,LTD. Yinchuan CN 100053713;100097301 CEP 2025-601 - Rev 00 2026/04/08 Valid 08/04/2031 Chemical 2026/04/08 New application|CEP granted|08/04/2026
937 Minoxidil ARENE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100033956;100079880 CEP 2025-226 - Rev 00 2026/04/08 Valid 08/04/2031 Chemical 2026/04/08 New application|CEP granted|08/04/2026
735 Prednisolone sodium phosphate SYMBIOTEC PHARMALAB LIMITED Indore IN 100018972;100095999 CEP 2011-149 - Rev 02 2026/04/02 Valid Chemical 2026/04/02 Notification|CEP granted|02/04/2026;
Minor revision|CEP granted|15/02/2022;
Notification|Rejected|15/11/2021
549 Dexamethasone sodium phosphate SYMBIOTICA SPECIALITY INGREDIENTS SDN. BHD. Butterworth MY 100014908;100053188 CEP 2006-184 - Rev 01 2026/04/02 Valid Chemical 2026/04/02 Major revision|CEP granted|02/04/2026
533 Triamcinolone acetonide, Micronised SYMBIOTEC PHARMALAB LIMITED Indore IN 100018972;100095999 CEP 2008-032 - Rev 05 2026/04/02 Valid Chemical 2026/04/02 Notification|CEP granted|02/04/2026;
Minor revision|CEP granted|06/04/2023;
Notification|Rejected|14/03/2023
654 Beclometasone dipropionate, Micronised, non-micronised SYMBIOTEC PHARMALAB LIMITED Indore IN 100018972;100095999 CEP 2005-062 - Rev 03 2026/04/02 Valid Chemical 2026/04/02 Notification|CEP granted|02/04/2026;
Minor revision|CEP granted|27/01/2023
2287 Fluconazole VIRUPAKSHA ORGANICS LIMITED Hyderabad IN 100021606;100076961 CEP 2009-364 - Rev 03 2026/04/02 Valid Chemical 2026/04/02 Monograph revision|CEP granted|02/04/2026;
Major revision|CEP granted|08/07/2025;
Minor revision|CEP granted|18/09/2023
811 Betamethasone valerate, Micronised SYMBIOTEC PHARMALAB LIMITED Indore IN 100018972;100095999 CEP 2008-307 - Rev 01 2026/04/02 Valid Chemical 2026/04/02 Notification|CEP granted|02/04/2026
933 Methylprednisolone acetate, Micronised SYMBIOTEC PHARMALAB LIMITED Indore IN 100018972;100095999 CEP 2011-063 - Rev 02 2026/04/02 Valid Chemical 2026/04/02 Notification|CEP granted|02/04/2026;
Notification|CEP granted|12/05/2021
2019 Perindopril tert-butylamine SHANGHAI PHARMA GROUP CHANGZHOU KONY PHARMACEUTICAL CO., LTD. Luoyang Town CN 100020594;100034407 CEP 2024-556 - Rev 00 2026/04/02 Valid 02/04/2031 Chemical 2026/04/02 New application|CEP granted|02/04/2026
140 Ethinylestradiol, Micronised SYMBIOTEC PHARMALAB LIMITED Indore IN 100018972;100095999 CEP 2020-029 - Rev 01 2026/04/02 Valid 06/10/2026 Chemical 2026/04/02 Notification|CEP granted|02/04/2026;
New application|CEP granted|06/10/2021
23 Diphenhydramine hydrochloride WANBURY LIMITED Thane IN 100021364;100030068 CEP 2013-285 - Rev 01 2026/04/02 Valid Chemical 2026/04/02 Minor revision|CEP granted|02/04/2026;
Renewal|CEP granted|22/03/2021;
Notification|Accepted - CEP remains valid|03/04/2020
2606 Tadalafil AMOLI ORGANICS PRIVATE LIMITED Mumbai IN 100016500;100025303 CEP 2016-183 - Rev 02 2026/04/02 Valid Chemical 2026/04/02 Major revision|CEP granted|02/04/2026;
Major revision|CEP granted|11/01/2024;
Renewal|CEP granted|27/02/2023;
Major revision|CEP granted|16/11/2020
2404 Drospirenone, Micronised, non-micronised SYMBIOTEC PHARMALAB LIMITED Indore IN 100018972;100095999 CEP 2018-118 - Rev 02 2026/04/02 Valid Chemical 2026/04/02 Notification|CEP granted|02/04/2026;
Renewal|CEP granted|11/09/2024
1783 Glycopyrronium bromide, Micronised VAMSI LABS LIMITED Solapur IN 100014747;100096958 CEP 2024-538 - Rev 00 2026/04/02 Valid 02/04/2031 Chemical 2026/04/02 New application|CEP granted|02/04/2026
335 Hydrocortisone, Micronised SYMBIOTEC PHARMALAB LIMITED Indore IN 100018972;100095999 CEP 2018-054 - Rev 04 2026/04/02 Valid Chemical 2026/04/02 Notification|CEP granted|02/04/2026;
Minor revision|CEP granted|30/10/2025;
Renewal|CEP granted|15/04/2024;
Minor revision|Accepted - CEP remains valid|28/11/2022;
Minor revision|CEP granted|31/08/2020
2127 Clobetasol propionate, Micronised, non-micronised SYMBIOTEC PHARMALAB LIMITED Indore IN 100018972;100095999 CEP 2007-263 - Rev 03 2026/04/01 Valid Chemical 2026/04/01 Notification|CEP granted|01/04/2026;
Monograph revision|Accepted - CEP remains valid|26/06/2020

数据库说明:

当前数据更新日期:2026年05月27日。
©2006-2026 DrugFuture->Certificates of Suitability to the monographs of European Pharmacopoeia, EDQM