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
. Collagen TIGER AESTHETICS MEDICAL LLC Conshohocken US 100054541;100096658 CEP 2010-223 - Rev 01 2025/06/13 Valid TSE 2025/06/13 Notification|CEP granted|13/06/2025
942 Omeprazole CIPLA LIMITED Mumbai IN 100006004;100018147 CEP 1997-122 - Rev 06 2025/06/13 Valid Chemical 2025/06/13 Minor revision|CEP granted|13/06/2025
47 Nicotinamide LONZA GUANGZHOU PHARMACEUTICAL LTD Guangzhou CN 100024633;100096813 CEP 2004-110 - Rev 07 2025/06/13 Valid Chemical 2025/06/13 Notification|CEP granted|13/06/2025;
Administrative procedure|CEP granted|28/09/2023;
Notification|Accepted - CEP remains valid|16/08/2023;
Notification|CEP granted|05/05/2021
1741 Trimetazidine dihydrochloride SHARON BIO-MEDICINE LIMITED Navi Mumbai IN 100017869;100077413 CEP 2010-075 - Rev 02 2025/06/13 Valid Chemical 2025/06/13 Minor revision|CEP granted|13/06/2025
14 Calcium carbonate SCORA Caffiers FR 100017757;100026517 CEP 1997-065 - Rev 05 2025/06/13 Valid Chemical 2025/06/13 Minor revision|CEP granted|13/06/2025
2049 Econazole PMC ISOCHEM Vert Le Petit FR 100011861;100020972 CEP 2020-047 - Rev 01 2025/06/13 Valid 18/09/2025 Chemical 2025/06/13 Minor revision|CEP granted|13/06/2025;
New application|CEP granted|18/09/2020
1653 Potassium clavulanate, diluted, with cellulose microcrystalline (0316) in ratio 1:1 SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD Datong CN 100033465;100082197 CEP 2014-327 - Rev 01 2025/06/13 Valid Chemical 2025/06/13 Minor revision|CEP granted|13/06/2025;
Renewal|CEP granted|05/03/2021
1794 Paclitaxel, Produced by a semi-synthetic process Fujian South Pharmaceutical Co., Ltd. Sanming CN 100012371;100021536 CEP 2019-110 - Rev 03 2025/06/13 Valid Chemical 2025/06/13 Renewal|CEP granted|13/06/2025;
Notification|CEP granted|16/06/2022;
Minor revision|Accepted - CEP remains valid|01/04/2022;
Minor revision|CEP granted|08/04/2021
2280 Fexofenadine hydrochloride HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2012-278 - Rev 04 2025/06/13 Valid Chemical 2025/06/13 Notification|CEP granted|13/06/2025;
Minor revision|CEP granted|12/03/2024;
Major revision|CEP granted|12/12/2022;
Major revision|CEP granted|23/03/2021;
Renewal|CEP granted|29/07/2020
2591 Celecoxib HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2016-037 - Rev 02 2025/06/13 Valid Chemical 2025/06/13 Notification|CEP granted|13/06/2025;
Minor revision|Accepted - CEP remains valid|27/11/2023;
Minor revision|CEP granted|22/02/2023;
Renewal|CEP granted|17/08/2022;
Minor revision|Accepted - CEP remains valid|29/04/2021;
Minor revision|Accepted - CEP remains valid|17/08/2020
1002 Diclofenac sodium SHANGHAI JINDI JIUZHOU PHARMACEUTICAL (ANYANG) CO., LTD. Anyang CN 100033462;100052355 CEP 2023-204 - Rev 00 2025/06/13 Valid 13/06/2030 Chemical 2025/06/13 New application|CEP granted|13/06/2025
2465 Irbesartan, Form-A CPL PHARMACEUTICALS PRIVATE LIMITED Ahmedabad IN 100048075;100079517 CEP 2023-237 - Rev 01 2025/06/13 Valid 12/06/2029 Chemical 2025/06/13 Minor revision|CEP granted|13/06/2025;
New application|CEP granted|12/06/2024
395 Hydrogen peroxide solution (3 per cent) ARKEMA FRANCE Puteaux FR 100049819;100096345 CEP 2022-162 - Rev 02 2025/06/13 Valid 20/12/2028 Chemical 2025/06/13 Notification|CEP granted|13/06/2025;
Administrative procedure|CEP granted|27/02/2024;
New application|CEP granted|20/12/2023
3035 Tapentadol hydrochloride ARENE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN 100033956;100079880 CEP 2024-524 - Rev 00 2025/06/13 Valid 13/06/2030 Chemical 2025/06/13 New application|CEP granted|13/06/2025
1108 Indapamide, Micronised KRKA TOVARNA ZDRAVIL D.D. NOVO MESTO Novo mesto SI 100000627;100009540 CEP 2024-179 - Rev 00 2025/06/13 Valid 13/06/2030 Chemical 2025/06/13 New application|CEP granted|13/06/2025
1292 Amphotericin B, Intended For Use in the Manufacture of Parenteral Preparations Asence Pharma Private Limited Vadodara IN 100023319;100088414 CEP 2024-118 - Rev 00 2025/06/13 Valid 13/06/2030 Chemical 2025/06/13 New application|CEP granted|13/06/2025
1995 Sodium glycerophosphate, hydrated MACCO ORGANIQUES, S.R.O. Bruntál CZ 100017613;100026377 CEP 2024-320 - Rev 00 2025/06/12 Valid 12/06/2030 Chemical 2025/06/12 New application|CEP granted|12/06/2025
721 Ibuprofen, IPA route SMS PHARMACEUTICALS LIMITED Hyderabad IN 100011780;100061058 CEP 2020-414 - Rev 02 2025/06/12 Valid 21/07/2027 Chemical 2025/06/12 Minor revision|CEP granted|12/06/2025;
Minor revision|CEP granted|25/03/2024;
Minor revision|Accepted - CEP remains valid|05/04/2023;
New application|CEP granted|21/07/2022
2589 Abacavir sulfate, Form-II HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2016-090 - Rev 01 2025/06/12 Valid Chemical 2025/06/12 Minor revision|CEP granted|12/06/2025;
Renewal|CEP granted|27/01/2023;
Minor revision|Accepted - CEP remains valid|13/07/2021;
Minor revision|CEP granted|25/03/2021;
Notification|Accepted - CEP remains valid|17/06/2020
1386 Albendazole RAKSHIT DRUGS PRIVATE LIMITED Hyderabad IN 100011756;100060531 CEP 2023-268 - Rev 00 2025/06/12 Valid 12/06/2030 Chemical 2025/06/12 New application|CEP granted|12/06/2025

数据库说明:

当前数据更新日期:2025年06月16日。
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