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
412 Sodium citrate dihydrate QUALITY CHEMICALS S.L. Esparreguera ES 100025665;100034895 CEP 2025-088 - Rev 00 2026/03/09 Valid 09/03/2031 Chemical 2026/03/09 New application|CEP granted|09/03/2026
1491 Amlodipine besilate MATRIX PHARMACORP PRIVATE LIMITED Sangareddy IN 100051463;100098142 CEP 2006-119 - Rev 06 2026/03/09 Valid Chemical 2026/03/09 Administrative procedure|CEP granted|09/03/2026;
Monograph revision|CEP granted|26/02/2026;
Notification|CEP granted|12/07/2024
369 Azathioprine APICHEM LABORATORIES PRIVATE LIMITED Yadadri Bhuvanagiri IN 100049373;100087707 CEP 2024-521 - Rev 00 2026/03/09 Valid 09/03/2031 Chemical 2026/03/09 New application|CEP granted|09/03/2026
3035 Tapentadol hydrochloride AMI LIFESCIENCES PRIVATE LIMITED Vadodara IN 100021822;100030527 CEP 2021-290 - Rev 01 2026/03/09 Valid 24/11/2027 Chemical 2026/03/09 Major revision|CEP granted|09/03/2026;
Minor revision|Accepted - CEP remains valid|23/02/2023;
New application|CEP granted|24/11/2022
3139 Brivaracetam, Process-II MICRO LABS LIMITED Bengaluru IN 100017819;100077269 CEP 2025-533 - Rev 00 2026/03/09 Valid 09/03/2031 Chemical 2026/03/09 New application|CEP granted|09/03/2026
879 Bromazepam F.I.S. - FABBRICA ITALIANA SINTETICI S.P.A. Montecchio Maggiore IT 100011866;100022277 CEP 2004-034 - Rev 03 2026/03/09 Valid Chemical 2026/03/09 Minor revision|CEP granted|09/03/2026;
Minor revision|Accepted - CEP remains valid|27/10/2022;
Monograph revision|Accepted - CEP remains valid|30/06/2022;
Minor revision|Accepted - CEP remains valid|03/06/2021
2232 Losartan potassium, Form I HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2009-247 - Rev 10 2026/03/09 Valid Chemical 2026/03/09 Minor revision|CEP granted|09/03/2026;
Notification|CEP granted|02/12/2024;
Notification|CEP granted|04/07/2023;
Minor revision|CEP granted|05/01/2023;
Minor revision|CEP granted|30/11/2021;
Minor revision|CEP granted|01/07/2020
2535 Levetiracetam, Site 2 ZHEJIANG JIANGBEI NANHAI PHARMACEUTICAL CO., LTD Linhai City CN 100049395;100084081 CEP 2023-031 - Rev 01 2026/03/06 Valid 17/03/2028 Chemical 2026/03/06 Minor revision|CEP granted|06/03/2026;
New application|CEP granted|17/03/2023
1491 Amlodipine besilate SMRUTHI ORGANICS LIMITED Solapur IN 100021370;100092013 CEP 2023-393 - Rev 00 2026/03/06 Valid 06/03/2031 Chemical 2026/03/06 New application|CEP granted|06/03/2026
573 Verapamil hydrochloride PIRAMAL PHARMA LIMITED Digwal Village IN 100036948;100058375 CEP 2005-141 - Rev 07 2026/03/06 Valid Chemical 2026/03/06 Minor revision|CEP granted|06/03/2026;
Minor revision|CEP granted|02/05/2022;
Notification|CEP granted|20/11/2020
1104 Fluoxetine hydrochloride CADILA PHARMACEUTICALS LIMITED Ankleshwar IN 100003616;100000498 CEP 2004-207 - Rev 08 2026/03/06 Valid Chemical 2026/03/06 Minor revision|CEP granted|06/03/2026;
Minor revision|CEP granted|30/06/2025;
Minor revision|CEP granted|07/03/2022;
Monograph revision|CEP granted|01/04/2021
2933 Deferasirox BAL PHARMA LIMITED Bengaluru IN 100016398;100041736 CEP 2024-364 - Rev 00 2026/03/06 Valid 06/03/2031 Chemical 2026/03/06 New application|CEP granted|06/03/2026
2336 Capsicum oleoresin, refined and standardised, DER: 62-83:1 ESPECIALIDADES FARMACEUTICAS CENTRUM S.A. Alicante ES 100000287;100004304 CEP 2024-163 - Rev 00 2026/03/05 Valid 05/03/2031 Herbal 2026/03/05 New application|CEP granted|05/03/2026
2119 Venlafaxine hydrochloride, Process-C HIKAL LIMITED Bengaluru IN 100014769;100023445 CEP 2020-400 - Rev 03 2026/03/05 Valid Chemical 2026/03/05 Renewal|CEP granted|05/03/2026;
Minor revision|CEP granted|28/08/2024;
Notification|CEP granted|07/09/2022;
Minor revision|Accepted - CEP remains valid|29/03/2022;
New application|CEP granted|11/03/2021
1385 Acitretin, Polymorph form-III, process-II USV PRIVATE LIMITED Mumbai IN 100006251;100010851 CEP 2025-572 - Rev 00 2026/03/04 Valid 04/03/2031 Chemical 2026/03/04 New application|CEP granted|04/03/2026
2777 Pregabalin, Process II, Milled, Form-I INTAS PHARMACEUTICALS LIMITED Ahmedabad IN 100011529;100023432 CEP 2022-028 - Rev 03 2026/03/04 Valid 04/07/2028 Chemical 2026/03/04 Minor revision|CEP granted|04/03/2026;
Minor revision|CEP granted|18/09/2025;
Minor revision|CEP granted|23/09/2024;
New application|CEP granted|04/07/2023
1798 Trospium chloride ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2010-040 - Rev 05 2026/03/04 Valid Chemical 2026/03/04 Minor revision|CEP granted|04/03/2026;
Notification|CEP granted|11/04/2025;
Minor revision|Accepted - CEP remains valid|30/06/2023;
Notification|CEP granted|02/12/2022;
Minor revision|Accepted - CEP remains valid|25/03/2021;
Minor revision|Accepted - CEP remains valid|18/08/2020
967 Acetylcysteine WUHAN GRAND HOYO CO., LTD. Wuhan CN 100023371;100090500 CEP 2022-064 - Rev 02 2026/03/04 Valid 23/05/2027 Chemical 2026/03/04 Notification|CEP granted|04/03/2026;
Minor revision|CEP granted|11/06/2024;
Notification|Rejected|07/03/2024;
New application|CEP granted|23/05/2022
1673 Isoflurane SHANDONG NEW TIME PHARMACEUTICAL CO., LTD. Linyi CN 100025540;100034769 CEP 2010-078 - Rev 02 2026/03/04 Valid Chemical 2026/03/04 Minor revision|CEP granted|04/03/2026;
Minor revision|Accepted - CEP remains valid|24/03/2025;
Notification|CEP granted|11/03/2025;
Minor revision|Accepted - CEP remains valid|04/09/2020
1765 Salmeterol xinafoate, Micronised MELODY HEALTHCARE PRIVATE LIMITED Mumbai IN 100014822;100073679 CEP 2020-070 - Rev 03 2026/03/04 Valid Chemical 2026/03/04 Minor revision|CEP granted|04/03/2026;
Renewal|CEP granted|25/06/2025;
Minor revision|CEP granted|30/08/2021;
New application|CEP granted|14/08/2020

数据库说明:

当前数据更新日期:2026年04月03日。
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