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
568 Propranolol hydrochloride MANKIND PHARMA LIMITED New Delhi IN 100040218;100065486 CEP 2021-104 - Rev 01 2025/06/20 Valid 30/08/2028 Chemical 2025/06/20 Notification|CEP granted|20/06/2025;
New application|CEP granted|30/08/2023
3087 Ticagrelor MANKIND PHARMA LIMITED New Delhi IN 100040218;100065486 CEP 2022-067 - Rev 01 2025/06/20 Valid 06/07/2028 Chemical 2025/06/20 Notification|CEP granted|20/06/2025;
New application|CEP granted|06/07/2023
101 Nitrofurantoin, Macrocrystals (Process-II) MANKIND PHARMA LIMITED New Delhi IN 100040218;100065486 CEP 2021-371 - Rev 01 2025/06/20 Valid 10/12/2026 Chemical 2025/06/20 Notification|CEP granted|20/06/2025;
New application|CEP granted|10/12/2021
889 Clomipramine Hydrochloride MANKIND PHARMA LIMITED New Delhi IN 100040218;100065486 CEP 2020-310 - Rev 01 2025/06/20 Valid 24/10/2027 Chemical 2025/06/20 Notification|CEP granted|20/06/2025;
New application|CEP granted|24/10/2022
687 Salbutamol sulfate, Process III, Non-micronised and Micronised CIPLA LIMITED Mumbai IN 100006004;100018147 CEP 2025-002 - Rev 00 2025/06/20 Valid 20/06/2030 Chemical 2025/06/20 New application|CEP granted|20/06/2025
560 Methotrexate RAVI BIOLIFE PRIVATE LTD. Mumbai IN 100048404;100086771 CEP 2024-257 - Rev 00 2025/06/20 Valid 20/06/2030 Chemical 2025/06/20 New application|CEP granted|20/06/2025
1466 Prazepam F.I.S. - FABBRICA ITALIANA SINTETICI S.P.A. Montecchio Maggiore IT 100011866;100022277 CEP 2023-291 - Rev 00 2025/06/20 Valid 20/06/2030 Chemical 2025/06/20 New application|CEP granted|20/06/2025
101 Nitrofurantoin, Macrocrystals ASOLUTION PHARMACEUTICALS PVT. LTD. Thane IN 100043528;100072005 CEP 2023-346 - Rev 00 2025/06/19 Valid 19/06/2030 Chemical 2025/06/19 New application|CEP granted|19/06/2025
1765 Salmeterol xinafoate, Micronised, non-micronised AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN 100045727;100075371 CEP 2008-239 - Rev 05 2025/06/19 Valid Chemical 2025/06/19 Minor revision|CEP granted|19/06/2025;
Notification|CEP granted|14/10/2022;
Notification|CEP granted|25/11/2021;
Minor revision|CEP granted|15/07/2021
2125 Doxazosin mesilate NOSCH LABS PRIVATE LIMITED Hyderabad IN 100020550;100029297 CEP 2023-154 - Rev 00 2025/06/19 Valid 19/06/2030 Chemical 2025/06/19 New application|CEP granted|19/06/2025
1188 Cefixime, Process 2 QILU ANTIBIOTICS PHARMACEUTICAL CO. LTD. Jinan CN 100033695;100052910 CEP 2021-361 - Rev 01 2025/06/19 Valid 09/12/2026 Chemical 2025/06/19 Minor revision|CEP granted|19/06/2025;
Major revision|Accepted - CEP remains valid|12/05/2022;
New application|CEP granted|09/12/2021
1248 Norfloxacin ZHEJIANG LEPU PHARMACEUTICAL CO., LTD Taizhou City CN 100033518;100052465 CEP 2006-037 - Rev 05 2025/06/19 Valid Chemical 2025/06/19 Minor revision|CEP granted|19/06/2025;
Minor revision|Accepted - CEP remains valid|12/11/2024;
Minor revision|CEP granted|20/02/2024;
Notification|CEP granted|16/08/2021;
Monograph revision|CEP granted|15/07/2021
1653 Potassium clavulanate, diluted, with silica, colloidal hydrated (0738) in ratio 1:1 SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD Datong CN 100033465;100082197 CEP 2014-329 - Rev 01 2025/06/18 Valid Chemical 2025/06/18 Minor revision|CEP granted|18/06/2025;
Renewal|CEP granted|03/03/2021
2858 Mometasone furoate monohydrate, Micronised CIPLA LIMITED Mumbai IN 100006004;100018147 CEP 2018-290 - Rev 02 2025/06/18 Valid Chemical 2025/06/18 Minor revision|CEP granted|18/06/2025;
Renewal|CEP granted|23/01/2025
1346 Metamizole sodium monohydrate HEBEI JIHENG PHARMACEUTICAL CO., LTD. Hengshui City CN 100016565;100052147 CEP 2005-143 - Rev 03 2025/06/18 Valid Chemical 2025/06/18 Minor revision|CEP granted|18/06/2025;
Minor revision|CEP granted|03/03/2021
2732 Dienogest STERLING S.p.A. Solomeo Di Corciano IT 100024377;100033551 CEP 2016-158 - Rev 01 2025/06/18 Valid Chemical 2025/06/18 Major revision|CEP granted|18/06/2025;
Renewal|CEP granted|02/08/2023
2762 Capecitabine SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN 100044578;100073706 CEP 2014-332 - Rev 03 2025/06/18 Valid Chemical 2025/06/18 Minor revision|CEP granted|18/06/2025;
Notification|Accepted - CEP remains valid|26/10/2023;
Minor revision|CEP granted|07/02/2023;
Notification|CEP granted|20/07/2022;
Renewal|CEP granted|30/09/2021;
Minor revision|Accepted - CEP remains valid|30/07/2020
464 Amitriptyline hydrochloride MANKIND PHARMA LIMITED New Delhi IN 100040218;100065486 CEP 2019-227 - Rev 01 2025/06/18 Withdrawn by Holder 2026/03/25 Chemical 2026/03/25
2856 Pirfenidone MICRO LABS LIMITED Bengaluru IN 100017819;100077269 CEP 2019-155 - Rev 02 2025/06/18 Valid Chemical 2025/06/18 Renewal|CEP granted|18/06/2025;
Minor revision|CEP granted|16/11/2022
2296 Pantoprazole sodium sesquihydrate MANKIND PHARMA LIMITED New Delhi IN 100040218;100065486 CEP 2021-073 - Rev 01 2025/06/18 Valid 14/11/2027 Chemical 2025/06/18 Notification|CEP granted|18/06/2025;
New application|CEP granted|14/11/2022

数据库说明:

当前数据更新日期:2026年04月06日。
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