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
2535 Levetiracetam CHIERON ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN 100053345;100094249 CEP 2023-046 - Rev 02 2025/12/18 Valid 15/05/2029 Chemical 2025/12/18 Minor revision|CEP granted|18/12/2025;
Notification|CEP granted|17/06/2025;
New application|CEP granted|15/05/2024
1556 Piretanide, Micronised ZENTIVA K.S. Prague CZ 100004108;100097772 CEP 2024-234 - Rev 01 2025/12/18 Valid 14/11/2030 Chemical 2025/12/18 Administrative procedure|CEP granted|18/12/2025;
New application|CEP granted|14/11/2025
. N-(Methylpolyoxyethylene oxycarbonyl)-1,2-dipalmitoyl-sn-glycero-3-phosphoethanolamine, sodium salt NOF CORP. Shibuya JP 100013118;100097453 CEP 2025-351 - Rev 00 2025/12/18 Valid 18/12/2030 TSE 2025/12/18 New application|CEP granted|18/12/2025
1281 Aceclofenac HENAN DONGTAI PHARM CO., LTD. Anyang CN 100023192;100052097 CEP 2023-072 - Rev 01 2025/12/18 Valid 25/07/2029 Chemical 2025/12/18 Minor revision|CEP granted|18/12/2025;
New application|CEP granted|26/07/2024
2258 Olanzapine, Form-I, Micronised CADILA PHARMACEUTICALS LIMITED Ankleshwar IN 100003616;100000498 CEP 2024-469 - Rev 00 2025/12/18 Valid 18/12/2030 Chemical 2025/12/18 New application|CEP granted|18/12/2025
926 Levonorgestrel, Process 2 INDUSTRIALE CHIMICA S.R.L. Saronno IT 100011692;100020331 CEP 2025-476 - Rev 00 2025/12/18 Valid 18/12/2030 Chemical 2025/12/18 New application|CEP granted|18/12/2025
2191 Atorvastatin calcium, Micronised ZHEJIANG HAISEN PHARMACEUTICAL CO., LTD. Xiangtan Village CN 100024637;100033815 CEP 2025-395 - Rev 00 2025/12/18 Valid 18/12/2030 Chemical 2025/12/18 New application|CEP granted|18/12/2025
2217 Lamivudine, Form-II, Process-II APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2015-092 - Rev 02 2025/12/17 Valid Chemical 2025/12/18 Minor revision|CEP granted|18/12/2025;
Notification|CEP granted|11/01/2024;
Renewal|CEP granted|29/06/2020
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

数据库说明:

当前数据更新日期:2025年12月20日。
©2006-2025 DrugFuture->Certificates of Suitability to the monographs of European Pharmacopoeia, EDQM