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
626 Neostigmine metilsulfate MAC CHEM PRODUCTS (INDIA) PRIVATE LIMITED Mumbai IN 100023737;100061579 CEP 2019-024 - Rev 02 2025/09/29 Valid Chemical 2025/09/29 Renewal|CEP granted|29/09/2025;
Administrative procedure|CEP granted|30/04/2024
572 Timolol maleate MICRO LABS LIMITED Bengaluru IN 100017819;100077269 CEP 2022-322 - Rev 01 2025/09/29 Valid 28/06/2028 Chemical 2025/09/29 Minor revision|CEP granted|29/09/2025;
New application|CEP granted|28/06/2023
875 Tranexamic acid AMI LIFESCIENCES PRIVATE LIMITED Vadodara IN 100021822;100030527 CEP 2019-250 - Rev 04 2025/09/29 Valid 28/07/2026 Chemical 2025/09/29 Major revision|CEP granted|29/09/2025;
Minor revision|CEP granted|02/01/2025;
Administrative procedure|CEP granted|04/04/2022;
Notification|CEP granted|18/01/2022
285 Noradrenaline tartrate HAMELN RDS S.R.O. Modra SK 100000646;100003437 CEP 2023-090 - Rev 02 2025/09/29 Valid 25/07/2029 Chemical 2025/09/29 Minor revision|CEP granted|29/09/2025;
Administrative procedure|CEP granted|01/08/2024;
New application|CEP granted|26/07/2024
2887 Raltegravir potassium MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2020-216 - Rev 02 2025/09/29 Valid 25/07/2027 Chemical 2025/09/29 Notification|CEP granted|29/09/2025;
Notification|CEP granted|25/07/2024;
Monograph revision|Accepted - CEP remains valid|30/03/2023;
New application|CEP granted|25/07/2022
2779 Solifenacin succinate, Process-II MICRO LABS LIMITED Bengaluru IN 100017819;100077269 CEP 2021-510 - Rev 02 2025/09/26 Valid 20/06/2027 Chemical 2025/09/26 Minor revision|CEP granted|26/09/2025;
Major revision|CEP granted|19/12/2024;
Minor revision|Accepted - CEP remains valid|05/07/2024;
New application|CEP granted|20/06/2022
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

数据库说明:

当前数据更新日期:2025年12月20日。
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