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
68 Atropine sulfate RESONANCE LABORATORIES PRIVATE LIMITED Bengaluru IN 100024014;100033182 CEP 2023-234 - Rev 00 2026/01/19 Valid 19/01/2031 Chemical 2026/01/19 New application|CEP granted|19/01/2026
2445 Adapalene AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN 100045727;100075371 CEP 2022-158 - Rev 01 2026/01/19 Valid 19/06/2029 Chemical 2026/01/19 Minor revision|CEP granted|19/01/2026;
New application|CEP granted|19/06/2024
1210 Fentanyl VERANOVA, L.P. West Deptford US 100012273;100018937 CEP 2000-141 - Rev 04 2026/01/19 Valid Chemical 2026/01/19 Minor revision|CEP granted|19/01/2026
110 Zinc chloride Merck KGaA Darmstadt DE 100000742;100006955 CEP 2014-168 - Rev 03 2026/01/19 Valid Chemical 2026/01/19 Minor revision|CEP granted|19/01/2026;
Major revision|CEP granted|03/10/2022;
Minor revision|CEP granted|29/11/2021;
Renewal|CEP granted|27/10/2020
698 Warfarin sodium IPCA LABORATORIES LIMITED Mumbai IN 100011685;100018680 CEP 2009-041 - Rev 03 2026/01/19 Valid Chemical 2026/01/19 Minor revision|CEP granted|19/01/2026;
Notification|Accepted - CEP remains valid|23/06/2023;
Minor revision|Accepted - CEP remains valid|09/04/2020
2762 Capecitabine HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2014-355 - Rev 05 2026/01/19 Valid Chemical 2026/03/26 Minor revision|Accepted - CEP remains valid|26/03/2026;
Notification|Rejected|26/02/2026;
Minor revision|CEP granted|19/01/2026;
Minor revision|CEP granted|20/05/2025;
Minor revision|CEP granted|22/01/2025;
Notification|Accepted - CEP remains valid|05/09/2023;
Major revision|CEP granted|16/06/2023;
Major revision|CEP granted|18/10/2022;
Renewal|CEP granted|24/09/2021;
Notification|CEP granted|24/07/2020
. Bovine Calf Serum MEDIATECH INC. Manassas US 100051460;100090205 CEP 2018-305 - Rev 02 2026/01/19 Valid TSE 2026/01/19 Major revision|CEP granted|19/01/2026;
Renewal|CEP granted|03/07/2024
2020 Rilmenidine dihydrogen phosphate ZENTIVA K.S. Prague CZ 100004108;100097772 CEP 2023-124 - Rev 01 2026/01/19 Valid 18/12/2029 Chemical 2026/01/19 Notification|CEP granted|19/01/2026;
New application|CEP granted|19/12/2024
2131 Tamsulosin hydrochloride, Ankleshwar site ZENTIVA K.S. Prague CZ 100004108;100097772 CEP 2023-469 - Rev 01 2026/01/19 Valid 25/04/2029 Chemical 2026/01/19 Notification|CEP granted|19/01/2026;
New application|CEP granted|25/04/2024
2768 Fluticasone furoate SHANDONG SIRUI PHARMACEUTICAL CO., LTD. Heze CN 100049295;100083729 CEP 2025-315 - Rev 00 2026/01/19 Valid 19/01/2031 Chemical 2026/01/19 New application|CEP granted|19/01/2026
14 Calcium carbonate, Granular Grade II SUDEEP PHARMA LIMITED Vadodara IN 100033274;100051937 CEP 2025-377 - Rev 00 2026/01/19 Valid 19/01/2031 Chemical 2026/01/19 New application|CEP granted|19/01/2026
292 Riboflavin, Fermentation process DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH 100053293;100094111 CEP 2000-088 - Rev 03 2026/01/16 Valid Chemical 2026/01/16 Minor revision|CEP granted|16/01/2026;
Notification|CEP granted|17/07/2025;
Minor revision|Accepted - CEP remains valid|09/08/2022
2203 Citalopram hydrochloride JUBILANT BIOSYS LIMITED Mysuru IN 100055198;100098088 CEP 2009-205 - Rev 03 2026/01/16 Valid Chemical 2026/01/16 Notification|CEP granted|16/01/2026;
Notification|CEP granted|24/08/2022
2232 Losartan potassium JUBILANT BIOSYS LIMITED Mysuru IN 100055198;100098088 CEP 2009-374 - Rev 05 2026/01/16 Valid Chemical 2026/01/16 Notification|CEP granted|16/01/2026;
Minor revision|CEP granted|03/11/2022;
Notification|CEP granted|11/08/2022;
Minor revision|Accepted - CEP remains valid|16/06/2022
2465 Irbesartan JUBILANT BIOSYS LIMITED Mysuru IN 100055198;100098088 CEP 2011-087 - Rev 06 2026/01/16 Valid Chemical 2026/01/16 Minor revision|CEP granted|16/01/2026;
Notification|CEP granted|17/10/2025;
Minor revision|CEP granted|25/03/2024;
Minor revision|CEP granted|23/10/2023;
Notification|CEP granted|11/08/2022;
Monograph revision|Accepted - CEP remains valid|28/07/2022
2366 Galantamine hydrobromide, Produced by a synthetic process JUBILANT BIOSYS LIMITED Mysuru IN 100055198;100098088 CEP 2011-123 - Rev 03 2026/01/16 Valid Chemical 2026/01/16 Notification|CEP granted|16/01/2026;
Notification|CEP granted|12/08/2022;
Monograph revision|CEP granted|04/06/2020
2018 Paroxetine hydrochloride hemihydrate JUBILANT BIOSYS LIMITED Mysuru IN 100055198;100098088 CEP 2009-204 - Rev 03 2026/01/16 Valid Chemical 2026/01/16 Notification|CEP granted|16/01/2026;
Notification|CEP granted|23/08/2022
2535 Levetiracetam JUBILANT BIOSYS LIMITED Mysuru IN 100055198;100098088 CEP 2011-159 - Rev 02 2026/01/16 Valid Chemical 2026/01/16 Notification|CEP granted|16/01/2026;
Notification|CEP granted|23/08/2022
1322 Fenofibrate VANAMALI ORGANICS PRIVATE LIMITED Hyderabad IN 100038866;100061082 CEP 2001-263 - Rev 09 2026/01/16 Valid Chemical 2026/01/16 Transfer of holdership|CEP granted|16/01/2026;
Notification|CEP granted|23/10/2024;
Minor revision|Accepted - CEP remains valid|28/05/2024;
Minor revision|CEP granted|04/05/2023;
Minor revision|Rejected|01/03/2023;
Notification|Accepted - CEP remains valid|14/06/2022;
Minor revision|Accepted - CEP remains valid|22/02/2022;
Minor revision|CEP granted|16/10/2020
2606 Tadalafil JUBILANT BIOSYS LIMITED Mysuru IN 100055198;100098088 CEP 2013-276 - Rev 02 2026/01/16 Valid Chemical 2026/01/16 Notification|CEP granted|16/01/2026;
Notification|CEP granted|12/08/2022

数据库说明:

当前数据更新日期:2026年05月28日。
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