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
603 Disulfiram SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN 100032307;100099917 CEP 2019-197 - Rev 03 2026/05/13 Valid Chemical 2026/05/13 Renewal|CEP granted|13/05/2026;
Minor revision|CEP granted|23/05/2025;
Major revision|CEP granted|15/07/2024;
Minor revision|Abandoned|18/03/2024
2600 Olmesartan medoxomil MACLEODS PHARMACEUTICALS LIMITED Mumbai IN 100021441;100077265 CEP 2014-196 - Rev 03 2026/05/13 Valid Chemical 2026/05/13 Minor revision|CEP granted|13/05/2026;
Major revision|CEP granted|04/02/2025;
Minor revision|CEP granted|13/03/2023;
Renewal|CEP granted|07/04/2022;
Minor revision|CEP granted|09/08/2021;
Minor revision|CEP granted|27/01/2021;
Minor revision|CEP granted|06/08/2020
2606 Tadalafil, D150 process ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100101905 CEP 2016-040 - Rev 02 2026/05/13 Valid Chemical 2026/05/13 Notification|CEP granted|13/05/2026;
Notification|CEP granted|09/04/2025;
Renewal|CEP granted|29/06/2022;
Minor revision|CEP granted|29/06/2020
2570 Desloratadine ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100101905 CEP 2014-047 - Rev 04 2026/05/13 Valid Chemical 2026/05/13 Notification|CEP granted|13/05/2026;
Notification|CEP granted|03/04/2025;
Minor revision|CEP granted|27/03/2023;
Notification|Rejected|23/02/2023;
Notification|CEP granted|02/12/2022;
Renewal|CEP granted|11/09/2020
2779 Solifenacin succinate ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100101905 CEP 2017-249 - Rev 04 2026/05/13 Valid Chemical 2026/05/13 Notification|CEP granted|13/05/2026;
Notification|CEP granted|09/04/2025;
Renewal|Accepted - CEP remains valid|17/09/2024;
Minor revision|CEP granted|04/04/2024;
Notification|CEP granted|02/12/2022;
Minor revision|Accepted - CEP remains valid|23/04/2021
2119 Venlafaxine hydrochloride ATUL BIOSCIENCE LIMITED Ambernath (East) IN 100044514;100086818 CEP 2022-447 - Rev 02 2026/05/13 Valid 24/04/2029 Chemical 2026/05/13 Minor revision|CEP granted|13/05/2026;
Minor revision|CEP granted|23/01/2025;
New application|CEP granted|24/04/2024
2631 Rosuvastatin calcium, D518 Process ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100101905 CEP 2021-265 - Rev 03 2026/05/13 Valid 05/01/2027 Chemical 2026/05/13 Notification|CEP granted|13/05/2026;
Notification|CEP granted|04/04/2025;
Notification|CEP granted|05/12/2022;
New application|CEP granted|05/01/2022
2631 Rosuvastatin calcium, Process IV ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100101905 CEP 2024-290 - Rev 02 2026/05/13 Valid 17/01/2030 Chemical 2026/05/13 Notification|CEP granted|13/05/2026;
Notification|CEP granted|10/04/2025;
New application|CEP granted|17/01/2025
2631 Rosuvastatin calcium, Process III ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100101905 CEP 2022-377 - Rev 02 2026/05/13 Valid 21/02/2028 Chemical 2026/05/13 Notification|CEP granted|13/05/2026;
Notification|CEP granted|10/04/2025;
New application|CEP granted|21/02/2023
3036 Teriflunomide ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100101905 CEP 2023-135 - Rev 02 2026/05/13 Valid 25/07/2029 Chemical 2026/05/13 Notification|CEP granted|13/05/2026;
Minor revision|CEP granted|11/03/2025;
New application|CEP granted|26/07/2024
2223 Glimepiride, Process-II ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100101905 CEP 2022-481 - Rev 02 2026/05/13 Valid 22/09/2028 Chemical 2026/05/13 Notification|CEP granted|13/05/2026;
Notification|CEP granted|04/04/2025;
New application|CEP granted|22/09/2023
2154 Telmisartan, Process II ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100101905 CEP 2022-047 - Rev 03 2026/05/13 Valid 13/05/2027 Chemical 2026/05/13 Notification|CEP granted|13/05/2026;
Notification|CEP granted|10/04/2025;
Minor revision|CEP granted|16/01/2023;
New application|CEP granted|13/05/2022
2191 Atorvastatin calcium, Form-I DR. REDDY'S LABORATORIES LIMITED Hyderabad IN 100003991;100000217 CEP 2011-222 - Rev 03 2026/05/12 Valid Chemical 2026/05/12 Minor revision|CEP granted|12/05/2026;
Minor revision|CEP granted|11/09/2023;
Monograph revision|CEP granted|09/12/2022
2598 Levofloxacin hemihydrate MATRIX PHARMACORP PRIVATE LIMITED Sangareddy IN 100051463;100098142 CEP 2019-161 - Rev 04 2026/05/12 Valid Chemical 2026/05/12 Renewal|CEP granted|12/05/2026;
Minor revision|Accepted - CEP remains valid|18/11/2024;
Notification|CEP granted|17/07/2024;
Minor revision|CEP granted|28/09/2023;
Minor revision|CEP granted|25/08/2022
668 Flucloxacillin sodium monohydrate, Sterile FRESENIUS KABI IPSUM S.R.L. Cassina de' Pecchi IT 100015105;100057989 CEP 1996-093 - Rev 08 2026/05/12 Valid Chemical 2026/05/12 Administrative procedure|CEP granted|12/05/2026;
Minor revision|CEP granted|30/04/2026;
Monograph revision|CEP granted|20/05/2022;
Major revision|CEP granted|16/06/2021;
Notification|CEP granted|02/02/2021
929 Loperamide hydrochloride FLEMING LABORATORIES LIMITED Nawabpet Village IN 100015641;100024384 CEP 2016-168 - Rev 04 2026/05/12 Valid Chemical 2026/05/12 Minor revision|CEP granted|12/05/2026;
Renewal|CEP granted|19/04/2024;
Administrative procedure|CEP granted|05/05/2022;
Major revision|CEP granted|11/02/2022;
Minor revision|Rejected|10/06/2021
2992 Lacosamide MACLEODS PHARMACEUTICALS LIMITED Mumbai IN 100021441;100077265 CEP 2018-151 - Rev 02 2026/05/12 Valid Chemical 2026/05/12 Minor revision|CEP granted|12/05/2026;
Renewal|CEP granted|29/10/2024
2422 Oseltamivir phosphate, Crystalline Form-A, Micronised and Non-micronised MSN PHARMACHEM PRIVATE LIMITED Sangareddy IN 100014794;100023345 CEP 2012-067 - Rev 03 2026/05/12 Valid Chemical 2026/05/12 Minor revision|CEP granted|12/05/2026;
Notification|CEP granted|25/10/2023;
Minor revision|CEP granted|28/10/2022
2033 Sodium (S)-lactate solution, 60% sodium lactate content MACCO ORGANIQUES, S.R.O. Bruntal CZ 100017613;100026377 CEP 2024-471 - Rev 01 2026/05/12 Valid 04/05/2031 Chemical 2026/05/12 Administrative procedure|CEP granted|12/05/2026;
New application|CEP granted|04/05/2026
2857 Trazodone hydrochloride AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A. Rome IT 100002269;100000484 CEP 2021-511 - Rev 02 2026/05/12 Valid 28/08/2028 Chemical 2026/05/12 Minor revision|CEP granted|12/05/2026;
Minor revision|Accepted - CEP remains valid|13/02/2026;
Notification|Accepted - CEP remains valid|09/01/2025;
Notification|CEP granted|28/03/2024;
New application|CEP granted|28/08/2023

数据库说明:

当前数据更新日期:2026年05月22日。
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