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
2423 Valsartan IPCA LABORATORIES LIMITED Mumbai IN 100011685;100018680 CEP 2010-100 - Rev 06 2025/09/22 Valid Chemical 2025/09/22 Minor revision|CEP granted|22/09/2025;
Minor revision|CEP granted|18/11/2022;
Minor revision|Accepted - CEP remains valid|15/06/2022;
Minor revision|CEP granted|01/12/2020;
Minor revision|Accepted - CEP remains valid|19/05/2020
1442 Leuprorelin CHEMI S.P.A. Patrica IT 100000347;100009242 CEP 2008-115 - Rev 05 2025/09/22 Valid Chemical 2025/09/22 Minor revision|CEP granted|22/09/2025;
Minor revision|CEP granted|10/03/2022;
Notification|Rejected|30/11/2021;
Minor revision|Accepted - CEP remains valid|28/05/2020
533 Triamcinolone acetonide AVIK PHARMACEUTICAL LIMITED Vapi IN 100023327;100041968 CEP 2018-231 - Rev 01 2025/09/22 Valid Chemical 2025/09/22 Renewal|CEP granted|22/09/2025;
Notification|Accepted - CEP remains valid|17/06/2022
687 Salbutamol sulfate, Micronised MELODY HEALTHCARE PRIVATE LIMITED Mumbai IN 100014822;100073679 CEP 2020-063 - Rev 03 2025/09/22 Valid Chemical 2025/09/22 Renewal|CEP granted|22/09/2025;
Monograph revision|CEP granted|25/03/2024;
Minor revision|CEP granted|23/03/2022;
New application|CEP granted|21/10/2020
2333 Fluvastatin sodium, Crystalline-2 BIOCON LIMITED Bengaluru IN 100011487;100018595 CEP 2022-130 - Rev 02 2025/09/22 Valid 15/06/2027 Chemical 2025/09/22 Minor revision|CEP granted|22/09/2025;
Administrative procedure|CEP granted|23/06/2022;
New application|CEP granted|15/06/2022
1300 Cefuroxime axetil, Amorphous TITAN PHARMACEUTICAL CO., LTD. (GUANGDONG) Heyuan City CN 100024682;100033865 CEP 2017-034 - Rev 01 2025/09/22 Valid Chemical 2025/09/22 Minor revision|CEP granted|22/09/2025;
Renewal|CEP granted|20/04/2023;
Minor revision|CEP granted|02/09/2021;
Minor revision|CEP granted|23/04/2021
2333 Fluvastatin sodium, Amorphous-2 BIOCON LIMITED Bengaluru IN 100011487;100018595 CEP 2022-139 - Rev 02 2025/09/22 Valid 22/07/2027 Chemical 2025/09/22 Minor revision|CEP granted|22/09/2025;
Administrative procedure|CEP granted|08/08/2022;
New application|CEP granted|22/07/2022
798 Fusidic acid, Process B FUJIAN COMHONY BIOTECHNOLOGY CO., LTD. Fuqing CN 100043888;100072481 CEP 2022-330 - Rev 02 2025/09/22 Valid 28/04/2028 Chemical 2025/09/22 Minor revision|CEP granted|22/09/2025;
Minor revision|CEP granted|15/10/2024;
New application|CEP granted|28/04/2023
848 Sodium fusidate, Process B FUJIAN COMHONY BIOTECHNOLOGY CO., LTD. Fuqing CN 100043888;100072481 CEP 2022-369 - Rev 02 2025/09/22 Valid 28/04/2028 Chemical 2025/09/22 Minor revision|CEP granted|22/09/2025;
Minor revision|CEP granted|04/11/2024;
New application|CEP granted|28/04/2023
1276 Vindesine sulfate MINAKEM Dunkerque FR 100032366;100056463 CEP 2025-393 - Rev 00 2025/09/22 Valid 22/09/2030 Chemical 2025/09/22 New application|CEP granted|22/09/2025
2191 Atorvastatin calcium, Process 4, polymorphic form-I TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2024-238 - Rev 02 2025/09/22 Valid 04/10/2029 Chemical 2025/09/22 Major revision|CEP granted|22/09/2025;
Notification|CEP granted|26/05/2025;
New application|CEP granted|07/10/2024
1472 Sodium hyaluronate, Intrinsic viscosity 1.55 m3/kg, by fermentation, for parenteral administration including intra-articular administration and for intra-ocular use AMHWA BIOPHARM CO., LTD. Binzhou CN 100054851;100097324 CEP 2018-285 - Rev 02 2025/09/19 Valid Chemical 2025/09/19 Renewal|CEP granted|19/09/2025;
Notification|CEP granted|21/06/2022
2737 Zolmitriptan MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2020-422 - Rev 03 2025/09/19 Valid 18/05/2027 Chemical 2025/09/19 Notification|CEP granted|19/09/2025;
Notification|CEP granted|15/07/2024;
Minor revision|CEP granted|13/10/2023;
Minor revision|Accepted - CEP remains valid|03/08/2023;
New application|CEP granted|18/05/2022
2465 Irbesartan, Process II MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2021-100 - Rev 04 2025/09/19 Valid 27/09/2026 Chemical 2025/09/19 Notification|CEP granted|19/09/2025;
Minor revision|Accepted - CEP remains valid|16/12/2024;
Notification|CEP granted|19/07/2024;
Minor revision|CEP granted|28/04/2023;
Minor revision|CEP granted|12/07/2022;
New application|CEP granted|27/09/2021
2585 Rizatriptan benzoate MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2011-299 - Rev 04 2025/09/19 Valid Chemical 2025/09/19 Notification|CEP granted|19/09/2025;
Notification|CEP granted|15/07/2024
2103 Propafenone hydrochloride MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2008-100 - Rev 05 2025/09/19 Valid Chemical 2025/09/19 Notification|CEP granted|19/09/2025;
Notification|CEP granted|11/07/2024;
Minor revision|Accepted - CEP remains valid|09/10/2020
1084 Cetirizine dihydrochloride MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2000-031 - Rev 13 2025/09/19 Valid Chemical 2025/09/19 Notification|CEP granted|19/09/2025;
Notification|CEP granted|19/07/2024;
Minor revision|Accepted - CEP remains valid|29/04/2024;
Minor revision|CEP granted|09/03/2022
2601 Pioglitazone hydrochloride MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2012-315 - Rev 02 2025/09/19 Valid Chemical 2025/09/19 Notification|CEP granted|19/09/2025;
Notification|CEP granted|11/07/2024;
Minor revision|Accepted - CEP remains valid|01/06/2021
2465 Irbesartan MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2010-124 - Rev 09 2025/09/19 Valid Chemical 2025/09/19 Notification|CEP granted|19/09/2025;
Minor revision|Accepted - CEP remains valid|19/12/2024;
Notification|CEP granted|19/07/2024;
Minor revision|CEP granted|26/04/2023;
Major revision|CEP granted|26/07/2022;
Major revision|CEP granted|10/06/2021
1756 Lamotrigine MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2009-157 - Rev 03 2025/09/19 Valid Chemical 2025/09/19 Notification|CEP granted|19/09/2025;
Notification|CEP granted|12/07/2024

数据库说明:

当前数据更新日期:2025年12月20日。
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