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
1756 Lamotrigine IPCA LABORATORIES LIMITED Mumbai IN 100011685;100018680 CEP 2018-293 - Rev 01 2025/12/17 Valid Chemical 2025/12/18 Renewal|CEP granted|18/12/2025;
Notification|Accepted - CEP remains valid|26/06/2023
334 Hydrocortisone acetate CURIA SPAIN S.A.U. Boecillo ES 100011649;100019586 CEP 2019-270 - Rev 02 2025/12/17 Valid Chemical 2025/12/18 Renewal|CEP granted|18/12/2025;
Notification|CEP granted|25/08/2021
2992 Lacosamide CHIERON ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN 100053345;100094249 CEP 2019-048 - Rev 02 2025/12/17 Valid Chemical 2025/12/18 Renewal|CEP granted|18/12/2025;
Notification|CEP granted|17/06/2025
1074 Biperiden hydrochloride, Bipe HCl 38 CF PHARMA LTD. Budapest HU 100022980;100031712 CEP 2020-317 - Rev 01 2025/12/17 Valid 17/03/2026 Chemical 2025/12/18 Minor revision|CEP granted|18/12/2025;
Minor revision|Accepted - CEP remains valid|02/01/2024;
New application|CEP granted|17/03/2021
2778 Sitagliptin phosphate monohydrate, Route STP Process micronised and non-micronised MSN LIFE SCIENCES PRIVATE LIMITED Bhiknoor Village IN 100018316;100070723 CEP 2020-200 - Rev 02 2025/12/17 Valid Chemical 2025/12/18 Renewal|CEP granted|18/12/2025;
Minor revision|CEP granted|21/01/2025;
New application|CEP granted|16/12/2020
1368 Ramipril, RMP EGIS Pharmaceuticals PLC Budapest HU 100001091;100001662 CEP 2020-284 - Rev 02 2025/12/17 Valid Chemical 2025/12/18 Renewal|CEP granted|18/12/2025;
Notification|CEP granted|28/02/2023;
New application|CEP granted|19/03/2021
. Bovine Albumin PROLIANT BIOLOGICALS, LLC Ankeny US 100049503;100084834 CEP 2001-120 - Rev 02 2025/12/16 Valid TSE 2025/12/16 Major revision|CEP granted|16/12/2025;
Notification|CEP granted|07/02/2024;
Notification|Abandoned|29/08/2023
2791 Clopidogrel hydrochloride, 313814 KRKA TOVARNA ZDRAVIL D.D. NOVO MESTO Novo mesto SI 100000627;100009540 CEP 2020-254 - Rev 02 2025/12/16 Valid Chemical 2025/12/16 Renewal|CEP granted|16/12/2025;
Notification|CEP granted|20/12/2022;
New application|CEP granted|18/03/2021
3052 Lercanidipine hydrochloride, Crystalline Form I MAITHRI DRUGS PRIVATE LIMITED Bonthapally Village IN 100020971;100029680 CEP 2024-503 - Rev 00 2025/12/16 Valid 16/12/2030 Chemical 2025/12/16 New application|CEP granted|16/12/2025
578 Ampicillin sodium, Sterile, Enzymatic route SANDOZ GMBH Kundl AT 100000546;100000450 CEP 2024-480 - Rev 01 2025/12/16 Valid 20/01/2030 Chemical 2025/12/16 Minor revision|CEP granted|16/12/2025;
New application|CEP granted|20/01/2025
517 Nystatin VUAB PHARMA A.S. Roztoky CZ 100000440;100007827 CEP 2003-118 - Rev 08 2025/12/16 Valid Chemical 2025/12/16 Minor revision|CEP granted|16/12/2025;
Notification|CEP granted|11/04/2023;
Notification|CEP granted|30/11/2020;
Notification|CEP granted|15/05/2020
1792 Nicotine resinate, Nicotine Content 18% with Glycerol 9.0-11.0% NICOBRAND LIMITED Coleraine GB 100002321;100006571 CEP 2022-477 - Rev 01 2025/12/16 Valid 21/08/2028 Chemical 2025/12/16 Notification|CEP granted|16/12/2025;
New application|CEP granted|21/08/2023
988 Cefazolin sodium, Sterile ACS DOBFAR S.P.A. Tribiano IT 100011589;100019524 CEP 1996-083 - Rev 07 2025/12/16 Valid Chemical 2025/12/16 Major revision|CEP granted|16/12/2025
578 Ampicillin sodium, Sterile SANDOZ GMBH Kundl AT 100000546;100000450 CEP 1993-005 - Rev 10 2025/12/16 Valid Chemical 2025/12/16 Minor revision|CEP granted|16/12/2025;
Minor revision|CEP granted|30/07/2025;
Minor revision|Rejected|26/08/2024;
Monograph revision|CEP granted|21/02/2024;
Minor revision|Accepted - CEP remains valid|30/06/2022;
Notification|Accepted - CEP remains valid|01/07/2021
411 Sodium acetate trihydrate Merck KGaA Darmstadt DE 100000742;100006955 CEP 2011-384 - Rev 02 2025/12/15 Valid Chemical 2025/12/15 Notification|CEP granted|15/12/2025;
Minor revision|Accepted - CEP remains valid|12/04/2024;
Major revision|CEP granted|03/12/2021
572 Timolol maleate PCAS Ecully FR 100011754;100054740 CEP 1996-049 - Rev 08 2025/12/15 Valid Chemical 2025/12/15 Minor revision|CEP granted|15/12/2025;
Minor revision|CEP granted|16/10/2023
2219 Lansoprazole NIFTY LABS PRIVATE LIMITED Hyderabad IN 100014767;100042749 CEP 2010-297 - Rev 05 2025/12/15 Valid Chemical 2025/12/15 Minor revision|CEP granted|15/12/2025;
Notification|CEP granted|24/09/2025;
Minor revision|CEP granted|26/03/2024;
Notification|CEP granted|16/08/2022;
Major revision|CEP granted|11/04/2022
2531 Clopidogrel hydrogen sulfate, Form-I PRAVEEN LABORATORIES PRIVATE LIMITED Surat IN 100033525;100087439 CEP 2014-176 - Rev 02 2025/12/15 Valid Chemical 2025/12/15 Minor revision|CEP granted|15/12/2025;
Minor revision|CEP granted|21/02/2024;
Renewal|CEP granted|05/11/2020
2154 Telmisartan, 315519 KRKA TOVARNA ZDRAVIL D.D. NOVO MESTO Novo mesto SI 100000627;100009540 CEP 2021-254 - Rev 02 2025/12/15 Valid 08/12/2026 Chemical 2025/12/15 Notification|CEP granted|15/12/2025;
Minor revision|CEP granted|01/09/2025;
New application|CEP granted|08/12/2021
2420 Tiotropium bromide monohydrate DEVA HOLDING A.Ş. Istanbul TR 100004235;100060052 CEP 2023-452 - Rev 00 2025/12/15 Valid 15/12/2030 Chemical 2025/12/15 New application|CEP granted|15/12/2025

数据库说明:

当前数据更新日期:2025年12月30日。
©2006-2025 DrugFuture->Certificates of Suitability to the monographs of European Pharmacopoeia, EDQM