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
2217 Lamivudine, Form II CIPLA LIMITED Mumbai IN 100006004;100018147 CEP 2007-103 - Rev 04 2025/09/26 Valid Chemical 2025/09/26 Minor revision|CEP granted|26/09/2025
2780 Temozolomide EXCELLA GMBH & CO. KG Feucht DE 100012030;100020739 CEP 2018-246 - Rev 04 2025/09/26 Valid Chemical 2025/09/26 Renewal|CEP granted|26/09/2025;
Minor revision|CEP granted|12/04/2024;
Administrative procedure|CEP granted|12/12/2023;
Minor revision|CEP granted|20/07/2021;
Notification|Accepted - CEP remains valid|01/10/2020
2993 Nilotinib hydrochloride monohydrate, Crystalline form-B, micronised and non-micronised MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN 100011732;100023530 CEP 2020-176 - Rev 01 2025/09/26 Valid 06/12/2027 Chemical 2025/09/26 Minor revision|CEP granted|26/09/2025;
New application|CEP granted|06/12/2022
2132 Torasemide IPCA LABORATORIES LIMITED Mumbai IN 100011685;100018680 CEP 2010-278 - Rev 02 2025/09/26 Valid Chemical 2025/09/26 Major revision|CEP granted|26/09/2025;
Minor revision|CEP granted|11/07/2023
2577 Oxcarbazepine BAJAJ HEALTHCARE LIMITED Thane IN 100021782;100061986 CEP 2021-340 - Rev 01 2025/09/26 Valid 17/02/2030 Chemical 2025/09/26 Minor revision|CEP granted|26/09/2025;
New application|CEP granted|17/02/2025
1300 Cefuroxime axetil APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2002-252 - Rev 08 2025/09/26 Valid Chemical 2025/09/26 Minor revision|CEP granted|26/09/2025;
Notification|CEP granted|13/12/2023;
Notification|Accepted - CEP remains valid|06/12/2022;
Notification|Rejected|03/11/2022;
Minor revision|Accepted - CEP remains valid|06/08/2021;
Minor revision|CEP granted|05/03/2021;
Minor revision|CEP granted|11/01/2021
2154 Telmisartan, Site II APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2020-290 - Rev 03 2025/09/26 Valid Chemical 2025/09/26 Renewal|CEP granted|26/09/2025;
Minor revision|CEP granted|30/10/2024;
Notification|CEP granted|05/01/2024;
New application|CEP granted|15/12/2020
2338 Mirtazapine, Hemihydrate MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2009-399 - Rev 06 2025/09/25 Valid Chemical 2025/09/25 Notification|CEP granted|25/09/2025;
Notification|CEP granted|30/07/2024;
Administrative procedure|CEP granted|18/11/2022;
Minor revision|CEP granted|28/10/2022
2416 Pramipexole dihydrochloride monohydrate MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2011-038 - Rev 06 2025/09/25 Valid Chemical 2025/09/25 Notification|CEP granted|25/09/2025;
Notification|CEP granted|30/07/2024;
Notification|CEP granted|28/09/2021
2002 Proguanil hydrochloride MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2009-199 - Rev 05 2025/09/25 Valid Chemical 2025/09/25 Notification|CEP granted|25/09/2025;
Notification|CEP granted|30/07/2024;
Notification|CEP granted|28/09/2021;
Minor revision|CEP granted|28/09/2020
2573 Candesartan cilexetil MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2011-259 - Rev 07 2025/09/25 Valid Chemical 2025/09/25 Notification|CEP granted|25/09/2025;
Notification|CEP granted|29/07/2024;
Notification|CEP granted|22/06/2022
2203 Citalopram hydrochloride MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2010-007 - Rev 05 2025/09/25 Valid Chemical 2025/09/25 Notification|CEP granted|25/09/2025;
Notification|CEP granted|29/07/2024
2733 Escitalopram oxalate MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2016-164 - Rev 02 2025/09/25 Valid Chemical 2025/09/25 Notification|CEP granted|25/09/2025;
Notification|CEP granted|29/07/2024;
Renewal|CEP granted|08/03/2022;
Minor revision|Accepted - CEP remains valid|29/05/2020
2778 Sitagliptin phosphate monohydrate, Product code: SPT-4 DR. REDDY'S LABORATORIES LIMITED Hyderabad IN 100003991;100000217 CEP 2025-020 - Rev 00 2025/09/25 Valid 25/09/2030 Chemical 2025/09/25 New application|CEP granted|25/09/2025
2630 Rivastigmine hydrogen tartrate MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2013-003 - Rev 04 2025/09/25 Valid Chemical 2025/09/25 Notification|CEP granted|25/09/2025;
Notification|CEP granted|30/07/2024;
Notification|CEP granted|28/09/2021;
Minor revision|CEP granted|24/06/2021
330 Gelatin, Caustic and lime hide gelatin GELITA AG Eberbach DE 100012955;100080863 CEP 2021-504 - Rev 01 2025/09/25 Valid 02/06/2027 TSE 2025/09/25 Transfer of holdership|CEP granted|25/09/2025;
New application|CEP granted|02/06/2022
2606 Tadalafil MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2012-021 - Rev 04 2025/09/25 Valid Chemical 2025/09/25 Notification|CEP granted|25/09/2025;
Notification|CEP granted|31/07/2024
930 Lysine Hydrochloride SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN 100025187;100034386 CEP 2012-007 - Rev 01 2025/09/25 Valid Chemical 2025/09/25 Minor revision|CEP granted|25/09/2025;
Notification|Accepted - CEP remains valid|07/05/2024;
Minor revision|Accepted - CEP remains valid|11/08/2023;
Notification|Accepted - CEP remains valid|11/02/2022;
Minor revision|Accepted - CEP remains valid|16/12/2021
312 Betamethasone, Micronised MSD EUROPE BELGIUM Watermael-Boitsfort BE 100049238;100083482 CEP 2012-214 - Rev 01 2025/09/25 Valid Chemical 2025/09/25 Minor revision|CEP granted|25/09/2025
1765 Salmeterol xinafoate MELODY HEALTHCARE PRIVATE LIMITED Mumbai IN 100014822;100073679 CEP 2010-097 - Rev 02 2025/09/25 Valid Chemical 2025/09/25 Minor revision|CEP granted|25/09/2025;
Minor revision|Accepted - CEP remains valid|27/11/2020;
Notification|Rejected|06/10/2020

数据库说明:

当前数据更新日期:2026年02月10日。
©2006-2026 DrugFuture->Certificates of Suitability to the monographs of European Pharmacopoeia, EDQM