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
20 Dextromethorphan hydrobromide monohydrate MALLADI DRUGS AND PHARMACEUTICALS LIMITED Renigunta IN 100017917;100061921 CEP 2018-133 - Rev 02 2025/03/17 Valid Chemical 2025/03/18 Renewal|CEP granted|18/03/2025;
Monograph revision|CEP granted|28/06/2024
678 Sodium valproate ASSURGEN PHARMA PVT LTD Lalamkoduru Village IN 100048048;100079469 CEP 2020-373 - Rev 01 2025/03/17 Valid 13/09/2026 Chemical 2025/03/18 Minor revision|CEP granted|18/03/2025;
Minor revision|Rejected|29/10/2024;
New application|CEP granted|13/09/2021
464 Amitriptyline hydrochloride DIPHARMA FRANCIS S.R.L. Baranzate IT 100014675;100030401 CEP 2013-281 - Rev 01 2025/03/17 Valid Chemical 2025/03/18 Minor revision|CEP granted|18/03/2025;
Renewal|CEP granted|23/03/2021
673 Medroxyprogesterone acetate, Micronised, Sterile FARMABIOS S.p.A Gropello Cairoli IT 100011643;100021232 CEP 2023-423 - Rev 00 2025/03/17 Valid 17/03/2030 Chemical 2025/03/18 New application|CEP granted|18/03/2025
1248 Norfloxacin, Product code 312025 KRKA TOVARNA ZDRAVIL D.D. NOVO MESTO Novo mesto SI 100000627;100009540 CEP 2021-141 - Rev 02 2025/03/17 Valid 20/12/2027 Chemical 2025/03/18 Minor revision|CEP granted|18/03/2025;
Minor revision|Accepted - CEP remains valid|13/08/2024;
Minor revision|CEP granted|06/02/2024;
New application|CEP granted|20/12/2022
426 Polysorbate 20 KOLB DISTRIBUTION LTD. Hedingen CH 100040656;100066825 CEP 2023-322 - Rev 00 2025/03/17 Valid 17/03/2030 Chemical 2025/03/18 New application|CEP granted|18/03/2025
2933 Deferasirox Ulkar Kimya Sanayii Ve Ticaret Anonim Sirketi Istanbul TR 100022492;100082995 CEP 2023-310 - Rev 00 2025/03/17 Valid 17/03/2030 Chemical 2025/03/18 New application|CEP granted|18/03/2025
179 Erythromycin, Process 2 SM BIOMED SDN BHD Sungai Petani MY 100018119;100026902 CEP 2020-007 - Rev 01 2025/03/14 Withdrawn by EDQM GMP non-compliance 2025/11/14 Chemical 2025/03/14
45 Methyldopa TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2010-326 - Rev 06 2025/03/14 Valid Chemical 2025/03/14 Notification|CEP granted|14/03/2025;
Notification|CEP granted|28/11/2023;
Notification|CEP granted|05/01/2022;
Minor revision|CEP granted|24/02/2021;
Minor revision|CEP granted|06/10/2020
2600 Olmesartan medoxomil TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2012-170 - Rev 02 2025/03/14 Valid Chemical 2025/03/14 Notification|CEP granted|14/03/2025;
Notification|CEP granted|25/05/2022;
Major revision|Rejected|08/09/2020
2232 Losartan potassium TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2011-105 - Rev 05 2025/03/14 Valid Chemical 2025/03/14 Notification|CEP granted|14/03/2025;
Notification|Accepted - CEP remains valid|11/04/2023;
Minor revision|Accepted - CEP remains valid|18/07/2022;
Minor revision|CEP granted|14/03/2022;
Minor revision|Accepted - CEP remains valid|23/03/2021;
Minor revision|CEP granted|03/09/2020
1789 Nadolol EUROAPI GERMANY GmbH Frankfurt am Main DE 100039255;100061797 CEP 2010-058 - Rev 03 2025/03/14 Valid Chemical 2025/03/14 Minor revision|CEP granted|14/03/2025;
Minor revision|Accepted - CEP remains valid|27/11/2024;
Transfer of holdership|CEP granted|10/12/2021
68 Atropine sulfate SCL LIFESCIENCES LIMITED Sahibzada Ajit Singh Nagar IN 100011774;100018647 CEP 2015-317 - Rev 02 2025/03/14 Valid Chemical 2025/03/14 Notification|CEP granted|14/03/2025;
Notification|Accepted - CEP remains valid|19/04/2024;
Minor revision|Accepted - CEP remains valid|14/12/2023;
Notification|Rejected|19/10/2023;
Minor revision|CEP granted|10/11/2022;
Notification|Rejected|01/08/2022;
Renewal|CEP granted|02/11/2021;
Administrative procedure|CEP granted|10/11/2020;
Minor revision|CEP granted|21/10/2020
2598 Levofloxacin hemihydrate SCL LIFESCIENCES LIMITED Sahibzada Ajit Singh Nagar IN 100011774;100018647 CEP 2019-315 - Rev 01 2025/03/14 Valid 18/05/2027 Chemical 2025/03/14 Notification|CEP granted|14/03/2025;
Minor revision|Accepted - CEP remains valid|28/05/2024;
Minor revision|Accepted - CEP remains valid|12/06/2023
2606 Tadalafil TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2013-152 - Rev 03 2025/03/14 Valid Chemical 2025/09/17 Notification|Accepted - CEP remains valid|17/09/2025;
Notification|CEP granted|14/03/2025;
Minor revision|Accepted - CEP remains valid|16/04/2024;
Minor revision|Accepted - CEP remains valid|07/03/2023;
Notification|CEP granted|07/03/2022;
Minor revision|CEP granted|24/03/2021
2988 Fingolimod hydrochloride TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2018-259 - Rev 05 2025/03/14 Valid Chemical 2025/03/14 Notification|CEP granted|14/03/2025;
Renewal|CEP granted|21/10/2024;
Monograph revision|CEP granted|05/06/2024;
Minor revision|Accepted - CEP remains valid|15/07/2022;
Notification|CEP granted|04/02/2022;
Minor revision|CEP granted|11/06/2021
2779 Solifenacin succinate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2020-248 - Rev 02 2025/03/14 Valid 24/11/2026 Chemical 2025/03/14 Notification|CEP granted|14/03/2025;
Notification|CEP granted|20/12/2021;
New application|CEP granted|24/11/2021
2777 Pregabalin, ID 3636/9111 TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2020-375 - Rev 03 2025/03/14 Valid 01/04/2026 Chemical 2025/03/14 Notification|CEP granted|14/03/2025;
Notification|CEP granted|08/02/2024;
Notification|CEP granted|20/12/2021;
New application|CEP granted|01/04/2021
2988 Fingolimod hydrochloride INTAS PHARMACEUTICALS LIMITED Ahmedabad IN 100011529;100023432 CEP 2020-090 - Rev 02 2025/03/14 Valid 02/07/2026 Chemical 2025/03/14 Notification|CEP granted|14/03/2025;
Monograph revision|Accepted - CEP remains valid|29/04/2024;
Minor revision|CEP granted|06/07/2023;
New application|CEP granted|02/07/2021
2531 Clopidogrel hydrogen sulfate SCL LIFESCIENCES LIMITED Sahibzada Ajit Singh Nagar IN 100011774;100018647 CEP 2022-148 - Rev 01 2025/03/14 Valid 31/10/2029 Chemical 2025/03/14 Notification|CEP granted|14/03/2025;
New application|CEP granted|31/10/2024

数据库说明:

当前数据更新日期:2026年02月03日。
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