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
3136 Saxagliptin monohydrate SYNTHIMED LABS PRIVATE LIMITED Derabassi IN 100052287;100092080 CEP 2024-432 - Rev 00 2026/02/03 Valid 03/02/2031 Chemical 2026/02/03 New application|CEP granted|03/02/2026
821 Estradiol hemihydrate ARESKO LIFE SCIENCES PRIVATE LIMITED Ramnagar IN 100051467;100090218 CEP 2024-230 - Rev 00 2026/02/03 Valid 03/02/2031 Chemical 2026/02/03 New application|CEP granted|03/02/2026
2866 Gefitinib, Micronised NATCO PHARMA LIMITED Hyderabad IN 100011544;100018604 CEP 2017-244 - Rev 03 2026/02/02 Valid Chemical 2026/02/02 Minor revision|CEP granted|02/02/2026;
Minor revision|CEP granted|07/02/2024;
Renewal|CEP granted|21/11/2023
1519 Flurbiprofen SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2003-154 - Rev 07 2026/02/02 Valid Chemical 2026/02/02 Minor revision|CEP granted|02/02/2026;
Monograph revision|CEP granted|14/04/2022;
Minor revision|Rejected|12/10/2020
675 Metronidazole CORDEN PHARMA BERGAMO S.P.A. Treviglio IT 100018132;100026914 CEP 1995-052 - Rev 03 2026/02/02 Valid Chemical 2026/02/02 Notification|CEP granted|02/02/2026
1275 Ursodeoxycholic acid SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN 100044578;100073706 CEP 2022-275 - Rev 01 2026/02/02 Valid 30/07/2029 Chemical 2026/02/02 Monograph revision|CEP granted|02/02/2026;
New application|CEP granted|30/07/2024
2777 Pregabalin CHROMO LABORATORIES INDIA PRIVATE LIMITED Pashamylaram IN 100038839;100060978 CEP 2023-298 - Rev 00 2026/02/02 Valid 02/02/2031 Chemical 2026/02/02 New application|CEP granted|02/02/2026
898 Dipotassium clorazepate monohydrate HONOUR LAB LIMITED Hyderabad IN 100011891;100097835 CEP 2024-134 - Rev 00 2026/02/02 Valid 02/02/2031 Chemical 2026/02/02 New application|CEP granted|02/02/2026
1491 Amlodipine besilate, Process II CIPLA LIMITED Mumbai IN 100006004;100018147 CEP 2015-140 - Rev 02 2026/02/02 Valid Chemical 2026/02/02 Monograph revision|CEP granted|02/02/2026;
Minor revision|CEP granted|02/05/2025;
Minor revision|Accepted - CEP remains valid|24/04/2023;
Renewal|CEP granted|16/09/2020
1977 Fluvoxamine maleate LAKE CHEMICALS PRIVATE LIMITED Bengaluru IN 100012055;100053935 CEP 2024-047 - Rev 00 2026/02/02 Valid 02/02/2031 Chemical 2026/02/02 New application|CEP granted|02/02/2026
333 Heparin sodium VIDARA PHARMA UNIPESSOAL LDA. Carnaxide PT 100004498;100075893 CEP 2002-012 - Rev 09 2026/02/02 Valid Chemical 2026/02/02 Notification|CEP granted|02/02/2026;
Monograph revision|Accepted - CEP remains valid|06/01/2026;
Notification|CEP granted|30/07/2025;
Major revision|CEP granted|27/11/2024;
Monograph revision|Accepted - CEP remains valid|19/06/2024;
Major revision|CEP granted|09/10/2020
662 Daunorubicin Hydrochloride ZHEJIANG HISUN PHARMACEUTICAL CO., LTD. Taizhou City CN 100011825;100018687 CEP 2012-380 - Rev 03 2026/01/30 Valid Chemical 2026/01/30 Monograph revision|CEP granted|30/01/2026;
Minor revision|CEP granted|08/03/2024;
Monograph revision|CEP granted|01/08/2023;
Notification|Accepted - CEP remains valid|12/09/2022
549 Dexamethasone sodium phosphate ZHEJIANG XIANJU PHARMACEUTICAL CO., LTD. Taizhou CN 100022759;100031459 CEP 2025-277 - Rev 00 2026/01/30 Valid 30/01/2031 Chemical 2026/01/30 New application|CEP granted|30/01/2026
1274 Tylosin tartrate for veterinary use ELANCO ANIMAL HEALTH INC. Greenfield US 100012274;100020462 CEP 2001-016 - Rev 06 2026/01/30 Valid Chemical 2026/01/30 Notification|CEP granted|30/01/2026;
Notification|CEP granted|09/12/2025;
Notification|Accepted - CEP remains valid|02/06/2025;
Major revision|CEP granted|07/10/2024
578 Ampicillin sodium, Sterile, Process-II APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2024-454 - Rev 00 2026/01/30 Valid 30/01/2031 Chemical 2026/01/30 New application|CEP granted|30/01/2026
2124 Loratadine, Process II, Micronised QUIMICA SINTETICA S.A. Alcala De Henares ES 100012121;100019020 CEP 2025-493 - Rev 00 2026/01/30 Valid 30/01/2031 Chemical 2026/01/30 New application|CEP granted|30/01/2026
432 Rifamycin sodium EUROAPI ITALY S.R.L. Brindisi IT 100039217;100061735 CEP 2011-233 - Rev 05 2026/01/30 Valid Chemical 2026/01/30 Monograph revision|CEP granted|30/01/2026;
Minor revision|CEP granted|09/07/2025;
Minor revision|Accepted - CEP remains valid|27/03/2025;
Notification|CEP granted|17/12/2021;
Notification|Accepted - CEP remains valid|04/08/2021;
Notification|CEP granted|09/11/2020
417 Oxygen, Salerno site SOL S.P.A. Monza IT 100002061;100001723 CEP 2025-380 - Rev 00 2026/01/30 Valid 30/01/2031 Chemical 2026/01/30 New application|CEP granted|30/01/2026
1081 Carboplatin QILU PHARMACEUTICAL CO., LTD. Jinan CN 100014051;100061315 CEP 2010-285 - Rev 05 2026/01/30 Valid Chemical 2026/01/30 Notification|CEP granted|30/01/2026;
Notification|CEP granted|23/05/2025;
Minor revision|CEP granted|14/02/2024;
Notification|Accepted - CEP remains valid|28/01/2022;
Notification|CEP granted|16/09/2021
2858 Mometasone furoate monohydrate STERLING S.p.A. Solomeo Di Corciano IT 100024377;100033551 CEP 2018-185 - Rev 02 2026/01/30 Valid Chemical 2026/01/30 Notification|CEP granted|30/01/2026;
Renewal|CEP granted|14/10/2024

数据库说明:

当前数据更新日期:2026年02月10日。
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