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
2570 Desloratadine DR. REDDY'S LABORATORIES LIMITED Hyderabad IN 100003991;100000217 CEP 2014-321 - Rev 02 2024/01/25 Valid Chemical 2024/01/25 Minor revision|CEP granted|25/01/2024;
Minor revision|CEP granted|05/04/2023;
Renewal|CEP granted|11/02/2021;
Minor revision|CEP granted|25/06/2020
1121 Lorazepam R L FINE CHEM PVT. LTD. Gowribidanur IN 100016723;100053383 CEP 2010-217 - Rev 03 2024/01/25 Valid Chemical 2024/09/19 Minor revision|Accepted - CEP remains valid|19/09/2024;
Minor revision|CEP granted|25/01/2024;
Minor revision|CEP granted|01/06/2022
942 Omeprazole ZHEJIANG HUAYI PHARMACEUTICAL CO., LTD. Yiwu CN 100012165;100019516 CEP 2012-326 - Rev 01 2024/01/25 Valid Chemical 2024/01/25 Minor revision|CEP granted|25/01/2024;
Notification|Accepted - CEP remains valid|01/02/2022
2254 Moxifloxacin hydrochloride, Monohydrate MACLEODS PHARMACEUTICALS LIMITED Mumbai IN 100021441;100077265 CEP 2015-269 - Rev 02 2024/01/25 Valid Chemical 2024/01/25 Notification|CEP granted|25/01/2024;
Minor revision|Abandoned|22/01/2024;
Minor revision|CEP granted|20/06/2023;
Renewal|CEP granted|27/07/2022;
Minor revision|CEP granted|29/03/2021;
Minor revision|Accepted - CEP remains valid|23/06/2020
2888 Rupatadine fumarate CADILA PHARMACEUTICALS LIMITED Ankleshwar IN 100003616;100000498 CEP 2018-161 - Rev 02 2024/01/25 Valid 02/06/2025 Chemical 2024/01/25 Minor revision|CEP granted|25/01/2024;
Minor revision|Accepted - CEP remains valid|01/08/2022;
Minor revision|CEP granted|18/12/2020
245 Pyridoxine hydrochloride, Grenzach II DSM Nutritional Products Ltd. Kaiseraugst CH 100012007;100022521 CEP 2022-492 - Rev 01 2024/01/25 Valid 20/12/2028 Chemical 2024/01/25 Administrative procedure|CEP granted|25/01/2024;
New application|CEP granted|20/12/2023
2593 Docetaxel WUHAN CALMLAND PHARMACEUTICALS CO., LTD. Wuhan CN 100049301;100083738 CEP 2022-011 - Rev 00 2024/01/25 Valid 25/01/2029 Chemical 2024/01/25 New application|CEP granted|25/01/2024
1970 Atracurium besilate, Manufacturing code: 55 CF PHARMA LTD. Budapest HU 100022980;100031712 CEP 2020-436 - Rev 02 2024/01/25 Valid 08/01/2026 Chemical 2024/01/25 Minor revision|CEP granted|25/01/2024;
Minor revision|Accepted - CEP remains valid|01/02/2022;
Minor revision|Accepted - CEP remains valid|18/11/2021;
Administrative procedure|CEP granted|11/02/2021;
New application|CEP granted|08/01/2021
522 Pholcodine monohydrate ALKALOIDA CHEMICAL COMPANY ZRT. Tiszavasvari HU 100001084;100002269 CEP 2016-268 - Rev 01 2024/01/25 Valid Chemical 2024/01/25 Renewal|CEP granted|25/01/2024;
Minor revision|Accepted - CEP remains valid|26/05/2021
3059 Melatonin FLAMMA S.P.A. Chignolo d'Isola IT 100012051;100020885 CEP 2023-171 - Rev 00 2024/01/24 Valid 24/01/2029 Chemical 2024/01/24 New application|CEP granted|24/01/2024
2373 Meloxicam, Powder and milled grade ESTEVE QUIMICA S.A. Barcelona ES 100002266;100056508 CEP 2011-037 - Rev 02 2024/01/24 Valid Chemical 2024/01/24 Notification|CEP granted|24/01/2024;
Notification|CEP granted|28/10/2020
578 Ampicillin sodium, Sterile and bacterial endotoxins free ACS DOBFAR S.P.A. Tribiano IT 100011589;100019524 CEP 2004-303 - Rev 03 2024/01/24 Valid Chemical 2024/01/24 Minor revision|CEP granted|24/01/2024;
Major revision|CEP granted|04/12/2020
1898 Valerian dry hydroalcoholic extract, DER: 2.5-3.3:1 GREENTECH Saint-Beauzire FR 100020293;100029057 CEP 2011-229 - Rev 01 2024/01/24 Suspended by Holder 2024/07/25 Herbal 2024/01/24 Transfer of holdership|CEP granted|24/01/2024
330 Gelatin, Limed bone gelatin TESSENDERLO GROUP N.V. Vilvoorde BE 100038809;100060926 CEP 2000-045 - Rev 06 2024/01/24 Valid TSE 2024/01/24 Administrative procedure|CEP granted|24/01/2024;
Major revision|CEP granted|03/01/2024
2114 Lysine acetate EVONIK REXIM S.A.S. Ham FR 100012329;100020964 CEP 2010-155 - Rev 03 2024/01/24 Valid Chemical 2024/01/24 Monograph revision|CEP granted|24/01/2024;
Notification|CEP granted|14/03/2022
2594 Duloxetine hydrochloride ZHEJIANG HUAYI PHARMACEUTICAL CO., LTD. Yiwu CN 100012165;100019516 CEP 2015-155 - Rev 01 2024/01/24 Valid Chemical 2024/01/24 Minor revision|CEP granted|24/01/2024;
Renewal|CEP granted|24/02/2022
1280 Zolpidem tartrate, Site-II APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2020-320 - Rev 02 2024/01/24 Valid 13/01/2026 Chemical 2024/01/24 Notification|CEP granted|24/01/2024;
Minor revision|CEP granted|22/09/2022;
New application|CEP granted|13/01/2021
1882 Passionflower herb dry extract, DER: 2-5:1 GREENTECH Saint-Beauzire FR 100020293;100029057 CEP 2011-230 - Rev 01 2024/01/24 Suspended by Holder 2024/07/25 Herbal 2024/01/24 Transfer of holdership|CEP granted|24/01/2024
1245 Nimodipine LUSOCHIMICA S.P.A. Lomagna IT 100018957;100027729 CEP 2022-403 - Rev 00 2024/01/24 Valid 24/01/2029 Chemical 2024/01/24 New application|CEP granted|24/01/2024
394 Hydrochlorothiazide MACLEODS PHARMACEUTICALS LIMITED Mumbai IN 100021441;100077265 CEP 2021-088 - Rev 00 2024/01/23 Valid 23/01/2029 Chemical 2024/01/23 New application|CEP granted|23/01/2024

数据库说明:

当前数据更新日期:2024年12月22日。
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