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
2930 Valganciclovir hydrochloride, Crystalline Type II OLON S.P.A. Rodano IT 100012085;100019537 CEP 2023-217 - Rev 00 2025/04/29 Valid 29/04/2030 Chemical 2025/09/03 Minor revision|Accepted - CEP remains valid|03/09/2025;
New application|CEP granted|29/04/2025
2733 Escitalopram oxalate, Process-IV NEULAND LABORATORIES LIMITED Hyderabad IN 100011545;100062134 CEP 2025-005 - Rev 01 2025/04/29 Valid 05/03/2030 Chemical 2025/04/29 Minor revision|CEP granted|29/04/2025;
New application|CEP granted|05/03/2025
2422 Oseltamivir phosphate, Form-A, route code OV MSN LIFE SCIENCES PRIVATE LIMITED Chandampet Village IN 100018316;100027671 CEP 2024-571 - Rev 00 2025/04/29 Valid 29/04/2030 Chemical 2025/04/29 New application|CEP granted|29/04/2025
2209 Sulbactam sodium, Sterile QILU ANTIBIOTICS PHARMACEUTICAL CO. LTD. Jinan CN 100033695;100052910 CEP 2024-030 - Rev 01 2025/04/29 Valid 14/03/2030 Chemical 2025/04/29 Administrative procedure|CEP granted|29/04/2025;
New application|CEP granted|14/03/2025
645 Tobramycin, Spray-dried, amorphous LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN 100020920;100029633 CEP 2024-023 - Rev 01 2025/04/29 Valid 25/06/2029 Chemical 2026/01/22 Monograph revision|Accepted - CEP remains valid|22/01/2026;
Notification|CEP granted|29/04/2025;
New application|CEP granted|25/06/2024
1489 Ambroxol hydrochloride, Process II AMI LIFESCIENCES PRIVATE LIMITED Karakhadi IN 100021822;100030527 CEP 2023-168 - Rev 01 2025/04/28 Valid 23/08/2028 Chemical 2025/04/28 Minor revision|CEP granted|28/04/2025;
New application|CEP granted|23/08/2023
2127 Clobetasol propionate CURIA SPAIN S.A.U. Boecillo ES 100011649;100019586 CEP 2011-095 - Rev 02 2025/04/28 Valid Chemical 2025/04/28 Minor revision|CEP granted|28/04/2025;
Notification|CEP granted|25/08/2021
2133 Troxerutin TOPFOND PHARMACEUTICAL CO., LTD. Zhumadian CN 100023369;100077278 CEP 2023-419 - Rev 00 2025/04/28 Valid 28/04/2030 Chemical 2025/04/28 New application|CEP granted|28/04/2025
38 Levodopa SHANDONG LUKANG PHARMACEUTICAL CO., LTD. Jining City CN 100025471;100071013 CEP 2022-202 - Rev 00 2025/04/28 Valid 28/04/2030 Chemical and TSE 2025/04/28 New application|CEP granted|28/04/2025
. Glutaraldehyde fixed bovine pericardium MERIL LIFE SCIENCES PRIVATE LIMITED Vapi IN 100054083;100095677 CEP 2024-425 - Rev 00 2025/04/25 Valid 25/04/2030 TSE 2025/04/25 New application|CEP granted|25/04/2025
2600 Olmesartan medoxomil CHROMO LABORATORIES INDIA PRIVATE LIMITED Pashamylaram IN 100038839;100060978 CEP 2018-083 - Rev 04 2025/04/25 Valid Chemical 2025/04/25 Renewal|CEP granted|25/04/2025;
Minor revision|CEP granted|03/08/2023;
Notification|Accepted - CEP remains valid|06/01/2023;
Minor revision|Accepted - CEP remains valid|21/12/2022;
Minor revision|CEP granted|06/09/2022;
Monograph revision|CEP granted|06/05/2022
2017 Oxaliplatin, Process HER-2 HERAEUS PRECIOUS METALS GMBH & CO. KG Hanau DE 100012310;100021629 CEP 2006-137 - Rev 06 2025/04/25 Valid Chemical 2025/04/25 Notification|CEP granted|25/04/2025;
Notification|CEP granted|02/10/2023;
Notification|CEP granted|18/07/2022;
Notification|CEP granted|24/03/2021
1614 Estradiol valerate ASPEN OSS B.V. Oss NL 100011619;100050602 CEP 2009-171 - Rev 02 2025/04/25 Valid Chemical 2025/04/25 Notification|CEP granted|25/04/2025
. Foetal Bovine Serum GLOBAL LIFE SCIENCES SOLUTIONS NEW ZEALAND Tauranga NZ 100052523;100092494 CEP 2000-211 - Rev 05 2025/04/25 Valid TSE 2025/04/25 Notification|CEP granted|25/04/2025;
Notification|CEP granted|25/02/2022;
Notification|CEP granted|05/06/2020
1517 Flumequine IPCA LABORATORIES LIMITED Mumbai IN 100011685;100018680 CEP 2001-318 - Rev 05 2025/04/25 Valid Chemical 2025/04/25 Minor revision|CEP granted|25/04/2025;
Notification|Rejected|08/04/2025;
Minor revision|CEP granted|16/07/2020
944 Piroxicam PFIZER INC. New York US 100004191;100077681 CEP 2001-427 - Rev 02 2025/04/25 Valid Chemical 2025/04/25 Minor revision|CEP granted|25/04/2025
3059 Melatonin SWATI SPENTOSE PRIVATE LIMITED Mumbai IN 100021605;100052219 CEP 2023-075 - Rev 03 2025/04/25 Valid 22/05/2029 Chemical 2025/04/25 Minor revision|CEP granted|25/04/2025;
Minor revision|CEP granted|17/02/2025;
Notification|CEP granted|16/09/2024;
New application|CEP granted|22/05/2024
2781 Tolterodine tartrate HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2020-032 - Rev 01 2025/04/25 Valid 17/03/2026 Chemical 2025/04/25 Minor revision|CEP granted|25/04/2025;
Minor revision|Accepted - CEP remains valid|24/08/2023;
New application|CEP granted|17/03/2021
2254 Moxifloxacin hydrochloride ENALTEC LABS PRIVATE LIMITED Navi Mumbai IN 100015510;100024234 CEP 2022-487 - Rev 00 2025/04/25 Valid 25/04/2030 Chemical 2025/04/25 New application|CEP granted|25/04/2025
2296 Pantoprazole sodium sesquihydrate SHOUGUANG FUKANG PHARMACEUTICAL CO., LTD. Shouguang City CN 100017920;100052986 CEP 2013-350 - Rev 01 2025/04/25 Valid Chemical 2025/04/25 Major revision|CEP granted|25/04/2025;
Renewal|CEP granted|15/09/2020

数据库说明:

当前数据更新日期:2026年04月02日。
©2006-2026 DrugFuture->Certificates of Suitability to the monographs of European Pharmacopoeia, EDQM