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
685 Povidone, K12 BOAI NKY MEDICAL HOLDINGS LTD. Jiaozuo CN 100051122;100089488 CEP 2024-232 - Rev 00 2025/07/07 Valid 07/07/2030 Chemical 2025/07/07 New application|CEP granted|07/07/2025
627 Nifedipine TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 1999-150 - Rev 06 2025/07/04 Valid Chemical 2025/07/04 Notification|CEP granted|04/07/2025;
Notification|CEP granted|05/01/2022;
Minor revision|CEP granted|17/06/2021
851 Pentoxifylline SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN 100032307;100078783 CEP 2000-127 - Rev 07 2025/07/04 Valid Chemical 2025/07/04 Major revision|CEP granted|04/07/2025;
Monograph revision|CEP granted|04/06/2020
2173 Gabapentin, Butanol process TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2013-327 - Rev 03 2025/07/04 Valid Chemical 2025/07/04 Notification|CEP granted|04/07/2025;
Notification|CEP granted|28/02/2022;
Minor revision|CEP granted|28/04/2021
2154 Telmisartan SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2009-229 - Rev 02 2025/07/04 Valid Chemical 2025/07/04 Minor revision|CEP granted|04/07/2025
653 Baclofen MEDILUX LABORATORIES PRIVATE LIMITED Pithampur IN 100023732;100032901 CEP 2017-133 - Rev 02 2025/07/04 Valid Chemical 2025/07/04 Monograph revision|CEP granted|04/07/2025;
Renewal|CEP granted|19/02/2024
687 Salbutamol sulfate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2020-100 - Rev 03 2025/07/04 Valid 14/09/2026 Chemical 2026/02/24 Minor revision|Rejected|24/02/2026;
Notification|CEP granted|04/07/2025;
Notification|CEP granted|24/10/2024;
Monograph revision|Accepted - CEP remains valid|01/02/2024;
Notification|CEP granted|20/12/2021;
New application|CEP granted|14/09/2021
2766 Exemestane CORAL DRUGS PRIVATE LIMITED New Delhi IN 100019182;100042823 CEP 2023-032 - Rev 00 2025/07/04 Valid 04/07/2030 Chemical 2025/07/04 New application|CEP granted|04/07/2025
1648 Thioctic acid, Type II OLON S.P.A. Rodano IT 100012085;100019537 CEP 2025-138 - Rev 00 2025/07/04 Valid 04/07/2030 Chemical 2025/07/04 New application|CEP granted|04/07/2025
3095 Dabigatran etexilate mesilate, Micronised and non-micronised ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN 100011833;100018698 CEP 2023-458 - Rev 00 2025/07/04 Valid 04/07/2030 Chemical 2026/01/26 Notification|Accepted - CEP remains valid|26/01/2026;
New application|CEP granted|04/07/2025
1275 Ursodeoxycholic acid CHANGDE YUNGANG BIOTECHNOLOGY CO. LTD. Changde CN 100048318;100079973 CEP 2023-296 - Rev 00 2025/07/04 Valid 04/07/2030 Chemical 2025/07/04 New application|CEP granted|04/07/2025
3036 Teriflunomide MAPRIMED S.A. Buenos Aires AR 100012039;100018552 CEP 2022-005 - Rev 01 2025/07/04 Valid 05/05/2028 Chemical 2025/07/04 Minor revision|CEP granted|04/07/2025;
Minor revision|Accepted - CEP remains valid|17/11/2023;
New application|CEP granted|05/05/2023
2306 Gemcitabine hydrochloride SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN 100044578;100073706 CEP 2006-222 - Rev 02 2025/07/03 Valid Chemical 2025/07/03 Minor revision|CEP granted|03/07/2025;
Minor revision|CEP granted|23/02/2023
2585 Rizatriptan benzoate APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2011-201 - Rev 04 2025/07/03 Valid Chemical 2025/07/03 Minor revision|CEP granted|03/07/2025;
Minor revision|CEP granted|07/05/2024;
Notification|CEP granted|05/01/2024;
Minor revision|Accepted - CEP remains valid|17/06/2022;
Monograph revision|CEP granted|23/02/2021
2531 Clopidogrel hydrogen sulfate, Form I ZYDUS LIFESCIENCES LIMITED Vadodara IN 100005979;100074301 CEP 2011-152 - Rev 05 2025/07/03 Valid Chemical 2025/07/03 Minor revision|CEP granted|03/07/2025;
Minor revision|CEP granted|20/12/2024;
Major revision|CEP granted|28/04/2023;
Notification|CEP granted|07/07/2022;
Minor revision|Accepted - CEP remains valid|29/06/2020
1611 Diosmin SICHUAN XIELI PHARMACEUTICAL CO., LTD. Pengzhou CN 100017947;100052361 CEP 2013-229 - Rev 02 2025/07/03 Valid Chemical 2025/07/03 Minor revision|CEP granted|03/07/2025;
Minor revision|CEP granted|03/06/2025;
Minor revision|Accepted - CEP remains valid|14/02/2023;
Minor revision|Accepted - CEP remains valid|19/01/2021;
Notification|Rejected|20/10/2020;
Minor revision|Accepted - CEP remains valid|24/08/2020
654 Beclometasone dipropionate, Micronised, non micronised TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2003-254 - Rev 07 2025/07/03 Valid Chemical 2025/07/03 Notification|CEP granted|03/07/2025;
Notification|CEP granted|17/08/2023;
Notification|CEP granted|04/01/2022;
Minor revision|CEP granted|22/01/2021
2780 Temozolomide SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN 100044578;100073706 CEP 2016-277 - Rev 01 2025/07/03 Valid Chemical 2025/07/03 Minor revision|CEP granted|03/07/2025;
Renewal|CEP granted|12/07/2022;
Monograph revision|Accepted - CEP remains valid|24/09/2020
1524 Gliclazide SOHAN HEALTHCARE PVT. LTD. Pune IN 100024454;100033626 CEP 2020-237 - Rev 01 2025/07/03 Valid 02/05/2028 Chemical 2025/07/03 Major revision|CEP granted|03/07/2025;
New application|CEP granted|02/05/2023
2631 Rosuvastatin calcium HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2016-097 - Rev 02 2025/07/03 Valid Chemical 2026/02/27 Major revision|Rejected|27/02/2026;
Notification|CEP granted|03/07/2025;
Notification|CEP granted|08/02/2023;
Renewal|CEP granted|02/09/2022;
Major revision|CEP granted|28/01/2021;
Minor revision|Rejected|05/10/2020;
Monograph revision|CEP granted|25/06/2020

数据库说明:

当前数据更新日期:2026年04月06日。
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