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
1787 Levomethadone hydrochloride HARMAN FINOCHEM LIMITED Mumbai IN 100011528;100020515 CEP 2015-380 - Rev 01 2025/04/16 Valid Chemical 2025/04/16 Notification|CEP granted|16/04/2025;
Renewal|CEP granted|11/02/2022
2778 Sitagliptin phosphate monohydrate HARMAN FINOCHEM LIMITED Mumbai IN 100011528;100020515 CEP 2021-117 - Rev 01 2025/04/16 Valid 22/06/2028 Chemical 2025/04/16 Notification|CEP granted|16/04/2025;
New application|CEP granted|22/06/2023
626 Neostigmine metilsulfate HARMAN FINOCHEM LIMITED Mumbai IN 100011528;100020515 CEP 2019-122 - Rev 02 2025/04/16 Valid Chemical 2025/11/12 Renewal|Accepted - CEP remains valid|12/11/2025;
Notification|CEP granted|16/04/2025;
Minor revision|Accepted - CEP remains valid|24/05/2024;
Administrative procedure|CEP granted|08/01/2021
1013 Felodipine IPCA LABORATORIES LIMITED Mumbai IN 100011685;100018680 CEP 2024-181 - Rev 00 2025/04/16 Valid 16/04/2030 Chemical 2025/04/16 New application|CEP granted|16/04/2025
285 Noradrenaline tartrate HARMAN FINOCHEM LIMITED Mumbai IN 100011528;100020515 CEP 2022-253 - Rev 01 2025/04/16 Valid 08/08/2028 Chemical 2025/04/16 Notification|CEP granted|16/04/2025;
Minor revision|Accepted - CEP remains valid|14/06/2024;
New application|CEP granted|08/08/2023
1449 Mometasone furoate AURISCO PHARMACEUTICAL CO., LTD. Tiantai CN 100011968;100018590 CEP 2008-094 - Rev 05 2025/04/15 Valid Chemical 2025/04/15 Minor revision|CEP granted|15/04/2025;
Minor revision|Accepted - CEP remains valid|10/03/2023;
Minor revision|CEP granted|10/11/2021
576 Allopurinol HARMAN FINOCHEM LIMITED Mumbai IN 100011528;100020515 CEP 2001-433 - Rev 06 2025/04/15 Valid Chemical 2025/04/15 Notification|CEP granted|15/04/2025;
Minor revision|CEP granted|11/03/2024;
Minor revision|Accepted - CEP remains valid|23/10/2020
1081 Carboplatin HERAEUS PRECIOUS METALS GMBH & CO. KG Hanau DE 100012310;100021629 CEP 2002-091 - Rev 09 2025/04/15 Valid Chemical 2025/04/15 Minor revision|CEP granted|15/04/2025;
Notification|CEP granted|02/10/2023;
Notification|CEP granted|02/08/2022
189 Methylphenobarbital HARMAN FINOCHEM LIMITED Mumbai IN 100011528;100020515 CEP 2005-202 - Rev 04 2025/04/15 Valid Chemical 2025/04/15 Notification|CEP granted|15/04/2025;
Minor revision|CEP granted|09/03/2023;
Minor revision|CEP granted|01/10/2020
2173 Gabapentin, Alternative process DIVI'S LABORATORIES LIMITED Hyderabad IN 100011666;100052116 CEP 2019-200 - Rev 01 2025/04/15 Valid Chemical 2025/10/06 Notification|Accepted - CEP remains valid|06/10/2025;
Renewal|CEP granted|15/04/2025;
Minor revision|Accepted - CEP remains valid|31/07/2023;
Notification|Rejected|12/06/2023;
Minor revision|Accepted - CEP remains valid|15/10/2021
1705 Sertraline hydrochloride VERDANT LIFE SCIENCES PRIVATE LIMITED Anakapalli IN 100048776;100081115 CEP 2022-191 - Rev 01 2025/04/15 Valid 31/08/2028 Chemical 2025/04/15 Major revision|CEP granted|15/04/2025;
New application|CEP granted|31/08/2023
1783 Glycopyrronium bromide HARMAN FINOCHEM LIMITED Mumbai IN 100011528;100020515 CEP 2012-017 - Rev 02 2025/04/15 Valid Chemical 2025/04/15 Notification|CEP granted|15/04/2025;
Minor revision|Accepted - CEP remains valid|25/11/2022;
Minor revision|CEP granted|01/12/2020
429 Progesterone, Micronised and non-micronised HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO., LTD. Ezhou City CN 100015482;100024200 CEP 2013-328 - Rev 01 2025/04/15 Valid Chemical 2025/04/15 Minor revision|CEP granted|15/04/2025
1280 Zolpidem tartrate ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2007-102 - Rev 05 2025/04/14 Valid Chemical 2025/04/14 Notification|CEP granted|14/04/2025;
Notification|CEP granted|05/12/2022;
Monograph revision|Accepted - CEP remains valid|14/10/2020
333 Heparin sodium, For parenteral preparations OPOCRIN SpA Formigine IT 100008856;100018068 CEP 2004-165 - Rev 06 2025/04/14 Valid Chemical 2026/01/21 Monograph revision|Accepted - CEP remains valid|21/01/2026;
Monograph revision|CEP granted|14/04/2025;
Notification|CEP granted|11/07/2024;
Notification|CEP granted|08/11/2021;
Major revision|CEP granted|19/08/2020
1482 Zinc acetate dihydrate QUALITY CHEMICALS S.L. Esparreguera ES 100025665;100034895 CEP 2018-117 - Rev 02 2025/04/14 Valid Chemical 2025/04/14 Renewal|CEP granted|14/04/2025;
Monograph revision|CEP granted|02/02/2023
937 Minoxidil VPL CHEMICALS PRIVATE LIMITED Bengaluru rural IN 100040785;100067088 CEP 2018-244 - Rev 02 2025/04/14 Valid Chemical 2025/04/14 Renewal|CEP granted|14/04/2025;
Notification|CEP granted|17/02/2023
2576 Voriconazole ALIVUS LIFE SCIENCES LIMITED Mumbai IN 100023468;100069944 CEP 2012-102 - Rev 03 2025/04/14 Valid Chemical 2025/04/14 Notification|CEP granted|14/04/2025;
Notification|CEP granted|05/12/2022
2465 Irbesartan, Form-A DIVI'S LABORATORIES LIMITED Hyderabad IN 100011666;100052116 CEP 2023-404 - Rev 00 2025/04/14 Valid 14/04/2030 Chemical 2025/04/14 New application|CEP granted|14/04/2025
2233 Marbofloxacin for veterinary use ZHEJIANG EXCEL PHARMACEUTICAL CO., LTD. Taizhou CN 100012381;100021159 CEP 2018-301 - Rev 03 2025/04/14 Valid Chemical 2025/04/14 Renewal|CEP granted|14/04/2025;
Monograph revision|CEP granted|03/04/2023;
Minor revision|CEP granted|30/07/2021

数据库说明:

当前数据更新日期:2026年02月10日。
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