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
2593 Docetaxel WUHAN CALMLAND PHARMACEUTICALS CO., LTD. Wuhan CN 100049301;100083738 CEP 2022-011 - Rev 01 2026/01/16 Valid 25/01/2029 Chemical 2026/01/16 Minor revision|CEP granted|16/01/2026;
Notification|Rejected|15/01/2025;
New application|CEP granted|25/01/2024
2778 Sitagliptin phosphate monohydrate JUBILANT BIOSYS LIMITED Mysuru IN 100055198;100098088 CEP 2021-175 - Rev 01 2026/01/16 Valid 31/08/2028 Chemical 2026/01/16 Notification|CEP granted|16/01/2026;
New application|CEP granted|01/09/2023
. Foetal Bovine Serum MEDIATECH INC. Manassas US 100051460;100090205 CEP 2018-271 - Rev 02 2026/01/16 Valid TSE 2026/01/16 Major revision|CEP granted|16/01/2026;
Renewal|CEP granted|03/07/2024
2296 Pantoprazole sodium sesquihydrate, Form-I DR. REDDY'S LABORATORIES LIMITED Hyderabad IN 100003991;100000217 CEP 2023-210 - Rev 01 2026/01/16 Valid 10/04/2029 Chemical 2026/01/16 Minor revision|CEP granted|16/01/2026;
New application|CEP granted|10/04/2024
2932 Rivaroxaban JUBILANT BIOSYS LIMITED Mysuru IN 100055198;100098088 CEP 2021-178 - Rev 01 2026/01/16 Valid 05/06/2029 Chemical 2026/01/16 Notification|CEP granted|16/01/2026;
New application|CEP granted|05/06/2024
685 Povidone, K30 SYNVENT NINGXIA CO.,LTD. Yinchuan CN 100053713;100097301 CEP 2025-305 - Rev 00 2026/01/16 Valid 16/01/2031 Chemical 2026/01/16 New application|CEP granted|16/01/2026
2465 Irbesartan SYNERGENE ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN 100038855;100091886 CEP 2023-330 - Rev 00 2026/01/16 Valid 16/01/2031 Chemical 2026/01/16 New application|CEP granted|16/01/2026
2888 Rupatadine fumarate TAGOOR LABORATORIES PRIVATE LIMITED Visakhapatnam IN 100044712;100079990 CEP 2025-343 - Rev 00 2026/01/16 Valid 16/01/2031 Chemical 2026/01/16 New application|CEP granted|16/01/2026
2097 Mebeverine hydrochloride SYNERGENE ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN 100038855;100091886 CEP 2023-409 - Rev 00 2026/01/16 Valid 16/01/2031 Chemical 2026/01/16 New application|CEP granted|16/01/2026
3132 Mirabegron VIWIT PHARMACEUTICAL CO. LTD Tengzhou CN 100049012;100082223 CEP 2024-039 - Rev 00 2026/01/16 Valid 16/01/2031 Chemical 2026/01/16 New application|CEP granted|16/01/2026
2932 Rivaroxaban, Micronised ZHEJIANG JINHUA CONBA BIO-PHARM. CO., LTD. Jinhua City CN 100024897;100034088 CEP 2024-021 - Rev 00 2026/01/16 Valid 16/01/2031 Chemical 2026/01/16 New application|CEP granted|16/01/2026
2888 Rupatadine fumarate URQUIMA S.A. Palau-solità i Plegamans ES 100004195;100003355 CEP 2017-202 - Rev 01 2026/01/16 Valid Chemical 2026/01/16 Minor revision|CEP granted|16/01/2026;
Renewal|CEP granted|09/08/2023;
Minor revision|CEP granted|14/12/2022;
Notification|Rejected|07/10/2022
1708 Azaperone for veterinary use MENADIONA, S.L. Palafolls ES 100015162;100023846 CEP 2017-190 - Rev 02 2026/01/14 Valid Chemical 2026/01/14 Administrative procedure|CEP granted|14/01/2026;
Renewal|CEP granted|28/03/2024
1765 Salmeterol xinafoate, Micronised, grades I and II CIPLA LIMITED Mumbai IN 100006004;100018147 CEP 2006-296 - Rev 06 2026/01/13 Valid Chemical 2026/01/13 Minor revision|CEP granted|13/01/2026;
Notification|CEP granted|12/04/2022
1275 Ursodeoxycholic acid, UDCAe "c" PharmaZell GmbH Raubling DE 100012552;100021381 CEP 2018-115 - Rev 02 2026/01/13 Valid Chemical and TSE 2026/01/13 Monograph revision|CEP granted|13/01/2026;
Minor revision|CEP granted|17/06/2024;
Renewal|CEP granted|10/08/2023;
Minor revision|CEP granted|19/09/2022;
Minor revision|Accepted - CEP remains valid|17/02/2022
1593 Megestrol acetate, Micronised and fine powder FARMABIOS S.p.A Gropello Cairoli IT 100011643;100021232 CEP 2002-181 - Rev 10 2026/01/13 Valid Chemical 2026/01/13 Minor revision|CEP granted|13/01/2026;
Minor revision|Accepted - CEP remains valid|30/08/2024;
Minor revision|CEP granted|30/05/2024;
Administrative procedure|CEP granted|05/05/2022;
Minor revision|CEP granted|14/04/2022;
Minor revision|CEP granted|16/10/2020
1444 Macrogols, Type 300, 400, 600, 1000, 1500, 3000, 3350, 4000 and 6000 CLARIANT PRODUKTE (DEUTSCHLAND) GMBH Frankfurt am Main DE 100016585;100056036 CEP 2002-180 - Rev 07 2026/01/13 Valid Chemical 2026/01/13 Minor revision|CEP granted|13/01/2026;
Notification|CEP granted|04/11/2024;
Minor revision|CEP granted|27/11/2023;
Minor revision|CEP granted|23/11/2020
2856 Pirfenidone JUBILANT BIOSYS LIMITED Mysuru IN 100055198;100098088 CEP 2018-091 - Rev 04 2026/01/13 Valid Chemical 2026/01/13 Notification|CEP granted|13/01/2026;
Renewal|CEP granted|20/08/2024;
Notification|CEP granted|23/08/2022
2600 Olmesartan medoxomil JUBILANT BIOSYS LIMITED Mysuru IN 100055198;100098088 CEP 2013-325 - Rev 02 2026/01/13 Valid Chemical 2026/01/13 Notification|CEP granted|13/01/2026;
Notification|CEP granted|12/08/2022;
Renewal|CEP granted|18/12/2020
1491 Amlodipine besilate, Site Khazipally AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100046306;100076393 CEP 2023-064 - Rev 01 2026/01/13 Valid 31/05/2028 Chemical 2026/01/13 Monograph revision|CEP granted|13/01/2026;
New application|CEP granted|31/05/2023

数据库说明:

当前数据更新日期:2026年05月28日。
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