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
2782 Vardenafil hydrochloride trihydrate MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2015-329 - Rev 02 2025/09/24 Valid Chemical 2025/09/24 Notification|CEP granted|24/09/2025;
Notification|CEP granted|30/07/2024;
Renewal|CEP granted|10/12/2021
2617 Aripiprazole NIFTY LABS PRIVATE LIMITED Hyderabad IN 100014767;100042749 CEP 2017-198 - Rev 04 2025/09/24 Valid Chemical 2025/09/24 Notification|CEP granted|24/09/2025;
Renewal|CEP granted|16/07/2024;
Notification|CEP granted|16/08/2022;
Monograph revision|CEP granted|06/07/2021
2988 Fingolimod hydrochloride MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2019-076 - Rev 04 2025/09/24 Valid Chemical 2025/09/24 Notification|CEP granted|24/09/2025;
Renewal|CEP granted|30/07/2025;
Notification|CEP granted|30/07/2024;
Monograph revision|Accepted - CEP remains valid|12/03/2024;
Notification|CEP granted|28/09/2021
2331 Rabeprazole sodium hydrate NIFTY LABS PRIVATE LIMITED Hyderabad IN 100014767;100042749 CEP 2020-166 - Rev 03 2025/09/24 Valid 03/09/2026 Chemical 2025/09/24 Notification|CEP granted|24/09/2025;
Minor revision|CEP granted|28/03/2024;
Notification|CEP granted|16/08/2022;
New application|CEP granted|03/09/2021
254 Adrenaline tartrate MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2015-013 - Rev 03 2025/09/24 Valid Chemical 2025/09/24 Notification|CEP granted|24/09/2025;
Notification|CEP granted|29/07/2024;
Notification|CEP granted|28/09/2021;
Renewal|CEP granted|15/06/2021
2541 Quetiapine Fumarate, Process-I NIFTY LABS PRIVATE LIMITED Hyderabad IN 100014767;100042749 CEP 2021-187 - Rev 01 2025/09/24 Valid 28/02/2029 Chemical 2025/09/24 Notification|CEP granted|24/09/2025;
New application|CEP granted|28/02/2024
2229 Enrofloxacin for veterinary use, Process II MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2023-424 - Rev 02 2025/09/24 Valid 14/02/2029 Chemical 2025/09/24 Notification|CEP granted|24/09/2025;
Notification|CEP granted|29/07/2024;
New application|CEP granted|14/02/2024
1250 Omega-3-acid ethyl esters 90, With alpha-tocopherol 2 SHANDONG TENMORE TRADING CO., LTD. Linyi CN 100051725;100090854 CEP 2025-341 - Rev 00 2025/09/24 Valid 24/09/2030 Chemical 2025/09/24 New application|CEP granted|24/09/2025
2125 Doxazosin mesilate NIFTY LABS PRIVATE LIMITED Hyderabad IN 100014767;100042749 CEP 2022-257 - Rev 01 2025/09/24 Valid 15/04/2029 Chemical 2025/09/24 Notification|CEP granted|24/09/2025;
New application|CEP granted|15/04/2024
2932 Rivaroxaban NIFTY LABS PRIVATE LIMITED Hyderabad IN 100014767;100042749 CEP 2022-375 - Rev 01 2025/09/24 Valid 17/05/2029 Chemical 2025/09/24 Notification|CEP granted|24/09/2025;
New application|CEP granted|17/05/2024
2541 Quetiapine Fumarate, Process II NIFTY LABS PRIVATE LIMITED Hyderabad IN 100014767;100042749 CEP 2021-289 - Rev 04 2025/09/24 Valid 01/04/2027 Chemical 2025/09/24 Notification|CEP granted|24/09/2025;
Minor revision|CEP granted|14/05/2024;
Minor revision|CEP granted|15/06/2023;
Notification|CEP granted|16/08/2022;
New application|CEP granted|01/04/2022
253 Ascorbic acid Luwei Pharmaceutical Group Co., Ltd Zibo CN 100049996;100087293 CEP 2023-408 - Rev 00 2025/09/24 Valid 24/09/2030 Chemical and TSE 2025/09/24 New application|CEP granted|24/09/2025
2230 Latanoprost CAYMAN PHARMA S.R.O. Neratovice CZ 100013822;100019767 CEP 2023-147 - Rev 01 2025/09/23 Valid 10/06/2030 Chemical 2025/09/23 Administrative procedure|CEP granted|23/09/2025;
New application|CEP granted|10/06/2025
2787 Esomeprazole magnesium dihydrate, Micronised 1 and Micronised 2 CIPLA LIMITED Mumbai IN 100006004;100018147 CEP 2014-077 - Rev 02 2025/09/23 Valid Chemical 2025/09/23 Minor revision|CEP granted|23/09/2025;
Minor revision|CEP granted|21/11/2024;
Renewal|CEP granted|26/08/2021
2616 Topiramate ZYDUS LIFESCIENCES LIMITED Vadodara IN 100005979;100074301 CEP 2021-419 - Rev 02 2025/09/23 Valid 24/03/2028 Chemical 2025/09/23 Minor revision|CEP granted|23/09/2025;
Minor revision|CEP granted|10/10/2024;
New application|CEP granted|24/03/2023
2600 Olmesartan medoxomil MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN 100051463;100098142 CEP 2012-043 - Rev 05 2025/09/23 Valid Chemical 2025/09/23 Notification|CEP granted|23/09/2025;
Notification|CEP granted|22/07/2024;
Notification|CEP granted|01/09/2021;
Major revision|CEP granted|02/11/2020
2787 Esomeprazole magnesium dihydrate, Micronised, non-micronised MINAKEM Dunkerque FR 100032366;100056463 CEP 2015-086 - Rev 01 2025/09/22 Valid Chemical 2025/09/22 Major revision|CEP granted|22/09/2025;
Notification|Accepted - CEP remains valid|15/11/2024;
Minor revision|Accepted - CEP remains valid|20/12/2023;
Minor revision|Accepted - CEP remains valid|15/07/2022;
Minor revision|Accepted - CEP remains valid|26/05/2021;
Renewal|CEP granted|31/08/2020
1563 Simvastatin, Ethanol process TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2010-130 - Rev 06 2025/09/22 Valid Chemical 2025/09/22 Notification|CEP granted|22/09/2025;
Notification|CEP granted|20/12/2021
929 Loperamide hydrochloride, Micronised LAKE CHEMICALS PRIVATE LIMITED Bengaluru IN 100012055;100053935 CEP 2009-362 - Rev 03 2025/09/22 Valid Chemical 2025/09/22 Minor revision|CEP granted|22/09/2025;
Notification|CEP granted|14/02/2023
2675 Irinotecan hydrochloride trihydrate QILU PHARMACEUTICAL CO., LTD. Jinan CN 100014051;100061315 CEP 2016-276 - Rev 02 2025/09/22 Valid Chemical 2025/09/22 Major revision|CEP granted|22/09/2025;
Minor revision|Accepted - CEP remains valid|31/01/2025;
Minor revision|CEP granted|26/06/2024;
Minor revision|Accepted - CEP remains valid|26/02/2024;
Renewal|CEP granted|25/08/2022;
Notification|Accepted - CEP remains valid|28/01/2022;
Notification|Accepted - CEP remains valid|10/11/2021;
Notification|CEP granted|16/09/2021;
Minor revision|CEP granted|19/06/2020

数据库说明:

当前数据更新日期:2025年12月20日。
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