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
1724 Formoterol fumarate dihydrate VAMSI LABS LIMITED Solapur IN 100014747;100096958 CEP 2006-227 - Rev 03 2025/06/24 Valid Chemical 2025/06/24 Notification|CEP granted|24/06/2025;
Notification|Accepted - CEP remains valid|22/09/2023;
Notification|CEP granted|28/07/2022;
Monograph revision|Accepted - CEP remains valid|06/05/2022
616 Haloperidol MANKIND PHARMA LIMITED New Delhi IN 100040218;100065486 CEP 2020-026 - Rev 03 2025/06/24 Valid 05/01/2027 Chemical 2025/06/24 Administrative procedure|CEP granted|24/06/2025;
Notification|CEP granted|06/06/2025;
Major revision|CEP granted|22/02/2024;
New application|CEP granted|05/01/2022
559 Mannitol, For use in the manufacture of parenteral preparations CARGILL S.R.L. Castelmassa IT 100049176;100083235 CEP 2005-019 - Rev 03 2025/06/24 Valid Chemical 2025/06/24 Notification|CEP granted|24/06/2025
2002 Proguanil hydrochloride HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2011-182 - Rev 01 2025/06/24 Valid Chemical 2025/06/24 Minor revision|CEP granted|24/06/2025;
Notification|Accepted - CEP remains valid|08/01/2024;
Minor revision|Accepted - CEP remains valid|19/04/2022;
Notification|Accepted - CEP remains valid|15/01/2021
1765 Salmeterol xinafoate, Non-micronised and micronised VAMSI LABS LIMITED Solapur IN 100014747;100096958 CEP 2006-226 - Rev 04 2025/06/24 Valid Chemical 2025/06/24 Notification|CEP granted|24/06/2025;
Minor revision|CEP granted|05/03/2024;
Notification|CEP granted|28/07/2022
1794 Paclitaxel, Produced by semi-synthetic process TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2009-236 - Rev 06 2025/06/24 Valid Chemical 2025/06/24 Minor revision|CEP granted|24/06/2025;
Major revision|CEP granted|25/11/2024;
Minor revision|CEP granted|27/02/2024;
Minor revision|CEP granted|19/11/2021
616 Haloperidol VAMSI LABS LIMITED Solapur IN 100014747;100096958 CEP 2020-149 - Rev 01 2025/06/24 Valid 04/04/2028 Chemical 2025/06/24 Notification|CEP granted|24/06/2025;
Minor revision|Accepted - CEP remains valid|20/08/2024;
Minor revision|Accepted - CEP remains valid|09/01/2024;
Notification|Rejected|26/09/2023;
New application|CEP granted|04/04/2023
1409 Clenbuterol Hydrochloride VAMSI LABS LIMITED Solapur IN 100014747;100096958 CEP 2020-172 - Rev 02 2025/06/24 Valid 30/03/2027 Chemical 2025/06/24 Notification|CEP granted|24/06/2025;
Notification|Accepted - CEP remains valid|21/09/2023;
Notification|CEP granted|28/07/2022;
New application|CEP granted|30/03/2022
1431 Haloperidol decanoate MANKIND PHARMA LIMITED New Delhi IN 100040218;100065486 CEP 2020-080 - Rev 03 2025/06/24 Valid 20/05/2027 Chemical 2025/06/24 Administrative procedure|CEP granted|24/06/2025;
Notification|CEP granted|06/06/2025;
Minor revision|Accepted - CEP remains valid|08/11/2024;
Major revision|CEP granted|30/08/2024;
New application|CEP granted|20/05/2022
901 Fenoterol hydrobromide VAMSI LABS LIMITED Solapur IN 100014747;100096958 CEP 2020-160 - Rev 03 2025/06/24 Valid 08/03/2027 Chemical 2025/06/24 Notification|CEP granted|24/06/2025;
Minor revision|CEP granted|14/11/2023;
Notification|Rejected|21/09/2023;
Notification|CEP granted|28/07/2022;
New application|CEP granted|08/03/2022
1750 Fluticasone propionate, Micronised VAMSI LABS LIMITED Solapur IN 100014747;100096958 CEP 2020-078 - Rev 03 2025/06/24 Valid 29/10/2026 Chemical 2025/06/24 Notification|CEP granted|24/06/2025;
Minor revision|CEP granted|11/12/2023;
Notification|CEP granted|28/07/2022;
New application|CEP granted|29/10/2021
2191 Atorvastatin calcium, Trihydrate MANKIND PHARMA LIMITED New Delhi IN 100040218;100065486 CEP 2022-262 - Rev 02 2025/06/24 Valid 16/02/2029 Chemical 2025/06/24 Administrative procedure|CEP granted|24/06/2025;
Notification|CEP granted|06/06/2025;
New application|CEP granted|16/02/2024
2931 Sorafenib tosilate, Form-I MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN 100011732;100023530 CEP 2023-185 - Rev 01 2025/06/24 Valid 29/10/2029 Chemical 2025/06/24 Monograph revision|CEP granted|24/06/2025;
New application|CEP granted|29/10/2024
919 Ipratropium bromide, Micronised VAMSI LABS LIMITED Solapur IN 100014747;100096958 CEP 2023-137 - Rev 01 2025/06/24 Valid 05/11/2029 Chemical 2025/06/24 Notification|CEP granted|24/06/2025;
New application|CEP granted|05/11/2024
1250 Omega-3-acid ethyl esters 90, Code K85EE - containing alpha tocopherol as antioxidant BASF AS Oslo NO 100003052;100032709 CEP 2008-132 - Rev 05 2025/06/23 Valid Chemical 2025/06/23 Minor revision|CEP granted|23/06/2025;
Notification|Accepted - CEP remains valid|25/07/2023;
Notification|CEP granted|21/01/2020
2541 Quetiapine Fumarate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2017-210 - Rev 05 2025/06/23 Valid Chemical 2025/06/23 Minor revision|CEP granted|23/06/2025;
Renewal|CEP granted|17/04/2024;
Minor revision|CEP granted|19/12/2023;
Minor revision|CEP granted|15/11/2022;
Minor revision|CEP granted|10/01/2022;
Minor revision|Accepted - CEP remains valid|06/11/2020
2779 Solifenacin succinate APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2016-059 - Rev 02 2025/06/23 Valid Chemical 2025/06/23 Minor revision|CEP granted|23/06/2025;
Notification|CEP granted|16/01/2024;
Renewal|CEP granted|27/09/2022
1524 Gliclazide, AP BAL PHARMA LIMITED Bengaluru IN 100016398;100041736 CEP 2013-039 - Rev 03 2025/06/23 Valid Chemical 2025/06/23 Notification|CEP granted|23/06/2025;
Administrative procedure|CEP granted|03/03/2025;
Minor revision|CEP granted|13/02/2025;
Renewal|CEP granted|27/08/2020
1250 Omega-3-acid ethyl esters 90, Code 03 K85EE - containing alpha tocopherol as antioxidant BASF AS Oslo NO 100003052;100032709 CEP 2008-330 - Rev 05 2025/06/23 Valid Chemical 2025/06/23 Minor revision|CEP granted|23/06/2025;
Notification|Accepted - CEP remains valid|25/07/2023;
Notification|CEP granted|21/01/2020
1563 Simvastatin, BHA, Process II SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN 100023303;100032437 CEP 2025-108 - Rev 00 2025/06/23 Valid 23/06/2030 Chemical 2025/06/23 New application|CEP granted|23/06/2025

数据库说明:

当前数据更新日期:2025年06月26日。
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