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
1710 Bisoprolol fumarate EGIS Pharmaceuticals PLC. Budapest X HU 100001091;100001662 CEP 2019-090 - Rev 01 2026/02/26 Valid Chemical 2026/02/26 Renewal|CEP granted|26/02/2026
2154 Telmisartan VERDANT LIFE SCIENCES PRIVATE LIMITED Anakapalli IN 100048776;100081115 CEP 2022-366 - Rev 01 2026/02/26 Valid 08/10/2029 Chemical 2026/02/26 Major revision|CEP granted|26/02/2026;
New application|CEP granted|09/10/2024
2191 Atorvastatin calcium, TBAH Sulphate Route APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2022-271 - Rev 03 2026/02/26 Valid 23/01/2028 Chemical 2026/02/26 Minor revision|CEP granted|26/02/2026;
Minor revision|CEP granted|25/07/2024;
Notification|CEP granted|13/12/2023;
New application|CEP granted|23/01/2023
2574 Entacapone COHANCE LIFESCIENCES LIMITED Mumbai IN 100011755;100090273 CEP 2011-006 - Rev 02 2026/02/26 Valid Chemical 2026/02/26 Notification|CEP granted|26/02/2026;
Notification|CEP granted|19/06/2020
2097 Mebeverine hydrochloride COHANCE LIFESCIENCES LIMITED Mumbai IN 100011755;100090273 CEP 2019-061 - Rev 03 2026/02/26 Valid Chemical 2026/02/26 Renewal|CEP granted|26/02/2026;
Notification|CEP granted|15/12/2022;
Monograph revision|Accepted - CEP remains valid|27/07/2022;
Notification|Accepted - CEP remains valid|09/07/2021;
Notification|CEP granted|14/12/2020
2577 Oxcarbazepine ZHEJIANG JIUZHOU PHARMACEUTICAL CO. LTD. Taizhou CN 100011841;100018560 CEP 2022-230 - Rev 03 2026/02/26 Valid 15/12/2028 Chemical 2026/02/26 Minor revision|CEP granted|26/02/2026;
Minor revision|CEP granted|12/12/2024;
Minor revision|Accepted - CEP remains valid|05/11/2024;
Minor revision|CEP granted|01/03/2024;
New application|CEP granted|15/12/2023
2637 Pemetrexed disodium heptahydrate SHANDONG BOYUAN PHARMACEUTICAL CO., LTD. Jinan CN 100037406;100076812 CEP 2015-217 - Rev 01 2026/02/26 Valid Chemical 2026/02/26 Minor revision|CEP granted|26/02/2026;
Monograph revision|Accepted - CEP remains valid|17/07/2023;
Renewal|CEP granted|23/02/2022
1491 Amlodipine besilate MATRIX PHARMACORP PRIVATE LIMITED Sangareddy IN 100051463;100098142 CEP 2006-119 - Rev 05 2026/02/26 Valid Chemical 2026/02/26 Monograph revision|CEP granted|26/02/2026;
Notification|CEP granted|12/07/2024
1456 Olive oil, refined, For parenteral use SOCIETE INDUSTRIELLE DES OLEAGINEUX SIO Saint Laurent Blangy FR 100018152;100094230 CEP 2015-167 - Rev 03 2026/02/26 Valid Chemical 2026/02/26 Minor revision|CEP granted|26/02/2026;
Notification|CEP granted|16/01/2025;
Minor revision|CEP granted|06/02/2024;
Minor revision|Accepted - CEP remains valid|16/03/2022;
Renewal|CEP granted|24/08/2020
2629 Rivastigmine Erregierre S.p.A. San Paolo D'Argon IT 100012035;100021179 CEP 2025-073 - Rev 00 2026/02/25 Valid 25/02/2031 Chemical 2026/02/25 New application|CEP granted|25/02/2026
1012 Famotidine HALEOS LABS LIMITED Hyderabad IN 100039495;100077080 CEP 2023-455 - Rev 01 2026/02/25 Valid 03/09/2030 Chemical 2026/02/25 Notification|CEP granted|25/02/2026;
New application|CEP granted|03/09/2025
803 Amiodarone hydrochloride EMCURE PHARMACEUTICALS LIMITED Pune IN 100011677;100099996 CEP 2024-451 - Rev 00 2026/02/25 Valid 25/02/2031 Chemical 2026/02/25 New application|CEP granted|25/02/2026
3078 Riociguat, Micronised MICRO LABS LIMITED Bengaluru IN 100017819;100077269 CEP 2025-423 - Rev 00 2026/02/25 Valid 25/02/2031 Chemical 2026/02/25 New application|CEP granted|25/02/2026
1611 Diosmin, Chenxiang site, micronised and non-micronised CHENGDU YAZHONG BIO-PHARMACEUTICAL CO., LTD. Pengzhou CN 100048965;100095919 CEP 2025-251 - Rev 01 2026/02/25 Valid 15/07/2030 Chemical 2026/02/25 Minor revision|CEP granted|25/02/2026;
New application|CEP granted|15/07/2025
823 Etoposide SHANDONG ANHONG PHARMACEUTICAL CO., LTD. Dezhou CN 100014777;100050265 CEP 2025-052 - Rev 00 2026/02/25 Valid 25/02/2031 Chemical 2026/02/25 New application|CEP granted|25/02/2026
3049 Etonogestrel, Micronised and non-micronised ASPEN OSS B.V. Oss NL 100011619;100050602 CEP 2024-341 - Rev 00 2026/02/25 Valid 25/02/2031 Chemical 2026/02/25 New application|CEP granted|25/02/2026
2777 Pregabalin HIKAL LIMITED Bengaluru IN 100014769;100023445 CEP 2016-181 - Rev 03 2026/02/25 Valid Chemical 2026/02/25 Minor revision|CEP granted|25/02/2026;
Minor revision|CEP granted|28/06/2023;
Notification|CEP granted|07/09/2022;
Renewal|CEP granted|15/06/2022;
Minor revision|Accepted - CEP remains valid|20/12/2021;
Minor revision|CEP granted|18/03/2021;
Major revision|CEP granted|24/11/2020;
Notification|Accepted - CEP remains valid|15/07/2020
2306 Gemcitabine hydrochloride, GA process HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2022-499 - Rev 01 2026/02/25 Valid 28/02/2028 Chemical 2026/02/25 Major revision|CEP granted|25/02/2026;
New application|CEP granted|28/02/2023
2191 Atorvastatin calcium, Crystalline BIOCON LIMITED Bengaluru IN 100011487;100018595 CEP 2011-009 - Rev 05 2026/02/25 Valid Chemical 2026/02/25 Minor revision|CEP granted|25/02/2026;
Notification|Accepted - CEP remains valid|11/09/2025;
Major revision|CEP granted|03/12/2024;
Monograph revision|CEP granted|08/12/2022;
Major revision|CEP granted|22/04/2021;
Minor revision|Rejected|26/10/2020;
Minor revision|CEP granted|18/06/2020
168 Ampicillin trihydrate, Enzymatic route APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2022-482 - Rev 03 2026/02/25 Valid 06/06/2028 Chemical 2026/02/25 Minor revision|CEP granted|25/02/2026;
Administrative procedure|CEP granted|28/11/2023;
Notification|CEP granted|21/11/2023;
New application|CEP granted|06/06/2023

数据库说明:

当前数据更新日期:2026年03月01日。
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