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
2702 Chlormadinone acetate, Micronised (grade 21), non-micronised FARMABIOS S.p.A Gropello Cairoli IT 100011643;100021232 CEP 2018-122 - Rev 05 2026/03/27 Valid Chemical 2026/03/27 Minor revision|CEP granted|27/03/2026;
Renewal|CEP granted|17/01/2025;
Minor revision|CEP granted|07/09/2023;
Minor revision|CEP granted|18/12/2020;
Minor revision|CEP granted|13/05/2020
2305 Vigabatrin MSN LIFE SCIENCES PRIVATE LIMITED Medak IN 100018316;100027671 CEP 2024-573 - Rev 00 2026/03/27 Valid 27/03/2031 Chemical 2026/03/27 New application|CEP granted|27/03/2026
601 Dimenhydrinate SHANGHAI WONDER PHARMACEUTICAL CO., LTD Shanghai CN 100020697;100029440 CEP 2020-110 - Rev 03 2026/03/27 Valid 03/03/2027 Chemical 2026/03/27 Notification|CEP granted|27/03/2026;
Minor revision|CEP granted|11/12/2025;
Notification|Accepted - CEP remains valid|07/07/2025;
Minor revision|CEP granted|15/02/2024;
New application|CEP granted|03/03/2022
1089 Ciprofloxacin NEULAND LABORATORIES LIMITED Hyderabad IN 100011545;100062134 CEP 2011-389 - Rev 05 2026/03/27 Valid Chemical 2026/03/27 Minor revision|CEP granted|27/03/2026;
Minor revision|CEP granted|13/01/2025;
Minor revision|CEP granted|28/11/2023;
Minor revision|CEP granted|12/07/2023;
Minor revision|Accepted - CEP remains valid|24/01/2022;
Notification|CEP granted|07/09/2021
2777 Pregabalin DONGBANG FUTURE TECH & LIFE CO., LTD. Hwaseong-Si KR 100024414;100042624 CEP 2018-148 - Rev 02 2026/03/25 Valid Chemical 2026/03/25 Notification|CEP granted|25/03/2026;
Renewal|CEP granted|11/03/2025
2600 Olmesartan medoxomil DONGBANG FUTURE TECH & LIFE CO., LTD. Hwaseong-Si KR 100024414;100042624 CEP 2015-237 - Rev 02 2026/03/25 Valid Chemical 2026/03/25 Notification|CEP granted|25/03/2026;
Minor revision|CEP granted|03/10/2024;
Renewal|CEP granted|16/11/2022;
Minor revision|CEP granted|25/01/2022;
Major revision|CEP granted|03/02/2021;
Minor revision|Abandoned|28/08/2020
922 Ketoprofen, Process N DONGBANG FUTURE TECH & LIFE CO., LTD. Hwaseong-Si KR 100024414;100042624 CEP 2017-194 - Rev 05 2026/03/25 Valid Chemical 2026/03/25 Notification|CEP granted|25/03/2026;
Monograph revision|CEP granted|21/11/2024;
Minor revision|CEP granted|17/04/2024;
Renewal|CEP granted|01/02/2024;
Minor revision|CEP granted|25/04/2023
1240 Mefenamic acid DONGBANG FUTURE TECH & LIFE CO., LTD. Hwaseong-Si KR 100024414;100042624 CEP 2004-296 - Rev 07 2026/03/25 Valid Chemical 2026/03/25 Notification|CEP granted|25/03/2026;
Minor revision|CEP granted|15/12/2021;
Minor revision|CEP granted|10/03/2020
2815 Entecavir monohydrate DONGBANG FUTURE TECH & LIFE CO., LTD. Hwaseong-Si KR 100024414;100042624 CEP 2018-093 - Rev 02 2026/03/25 Valid Chemical 2026/03/25 Notification|CEP granted|25/03/2026;
Renewal|CEP granted|15/01/2025
2591 Celecoxib DONGBANG FUTURE TECH & LIFE CO., LTD. Hwaseong-Si KR 100024414;100042624 CEP 2015-185 - Rev 01 2026/03/25 Valid Chemical 2026/03/25 Notification|CEP granted|25/03/2026;
Renewal|CEP granted|14/02/2022
335 Hydrocortisone ZHEJIANG ACINOVA PHARMACEUTICAL CO., LTD. Taizhou CN 100054484;100096546 CEP 2017-208 - Rev 04 2026/03/25 Valid Chemical 2026/03/25 Monograph revision|CEP granted|25/03/2026;
Major revision|CEP granted|03/02/2026;
Notification|CEP granted|27/05/2025;
Renewal|CEP granted|19/07/2024
2779 Solifenacin succinate DONGBANG FUTURE TECH & LIFE CO., LTD. Hwaseong-Si KR 100024414;100042624 CEP 2021-418 - Rev 01 2026/03/25 Valid 21/03/2028 Chemical 2026/03/25 Notification|CEP granted|25/03/2026;
New application|CEP granted|21/03/2023
2773 Memantine hydrochloride MEGAFINE PHARMA PRIVATE LIMITED Mumbai IN 100011550;100021133 CEP 2025-233 - Rev 00 2026/03/25 Valid 25/03/2031 Chemical 2026/03/25 New application|CEP granted|25/03/2026
2598 Levofloxacin hemihydrate SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN 100023303;100032437 CEP 2020-041 - Rev 03 2026/03/25 Valid Chemical 2026/03/25 Renewal|CEP granted|25/03/2026;
Minor revision|Accepted - CEP remains valid|24/04/2024;
Notification|CEP granted|26/01/2024;
Minor revision|CEP granted|04/10/2023;
New application|CEP granted|16/06/2021
2932 Rivaroxaban DONGBANG FUTURE TECH & LIFE CO., LTD. Hwaseong-Si KR 100024414;100042624 CEP 2021-211 - Rev 01 2026/03/25 Valid 21/08/2028 Chemical 2026/03/25 Notification|CEP granted|25/03/2026;
New application|CEP granted|21/08/2023
2131 Tamsulosin hydrochloride DONGBANG FUTURE TECH & LIFE CO., LTD. Hwaseong-Si KR 100024414;100042624 CEP 2022-178 - Rev 01 2026/03/25 Valid 16/04/2029 Chemical 2026/03/25 Notification|CEP granted|25/03/2026;
New application|CEP granted|16/04/2024
2778 Sitagliptin phosphate monohydrate DONGBANG FUTURE TECH & LIFE CO., LTD. Hwaseong-Si KR 100024414;100042624 CEP 2020-028 - Rev 03 2026/03/25 Valid 09/02/2027 Chemical 2026/03/25 Notification|CEP granted|25/03/2026;
Notification|CEP granted|28/06/2024;
Minor revision|CEP granted|08/04/2022;
New application|CEP granted|09/02/2022
658 Chlorhexidine digluconate solution AVA, INC. Willowbrook US 100046940;100077486 CEP 2022-038 - Rev 01 2026/03/25 Valid 05/06/2029 Chemical 2026/03/25 Monograph revision|CEP granted|25/03/2026;
New application|CEP granted|05/06/2024
673 Medroxyprogesterone acetate XIANJU SYNSEA BIOPHA CO. LTD. Taizhou CN 100056398;100101023 CEP 2019-336 - Rev 01 2026/03/24 Valid 26/11/2026 Chemical 2026/03/24 Transfer of holdership|CEP granted|24/03/2026
. Bovine pericardial tissue MEDTRONIC, INC. Santa Ana US 100056460;100101181 CEP 2012-075 - Rev 03 2026/03/24 Valid TSE 2026/03/24 Major revision|CEP granted|24/03/2026;
Major revision|CEP granted|17/07/2023;
Notification|CEP granted|05/08/2020

数据库说明:

当前数据更新日期:2026年04月02日。
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