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
429 Progesterone, Micronised, non-micronised ZHEJIANG SHENZHOU PHARMACEUTICAL CO., LTD. Taizhou CN 100011902;100052470 CEP 2012-412 - Rev 01 2026/04/29 Valid Chemical 2026/04/29 Minor revision|CEP granted|29/04/2026
875 Tranexamic acid JIANGSU TIANHE PHARMACEUTICAL CO., LTD. Yangzhou CN 100041985;100069208 CEP 2023-449 - Rev 00 2026/04/29 Valid 29/04/2031 Chemical 2026/04/29 New application|CEP granted|29/04/2026
2773 Memantine hydrochloride KRKA TOVARNA ZDRAVIL D.D. NOVO MESTO Novo mesto SI 100000627;100009540 CEP 2025-376 - Rev 00 2026/04/29 Valid 29/04/2031 Chemical 2026/04/29 New application|CEP granted|29/04/2026
923 Labetalol Hydrochloride OLON S.P.A. Rodano IT 100012085;100019537 CEP 2004-289 - Rev 06 2026/04/29 Valid Chemical 2026/04/29 Minor revision|CEP granted|29/04/2026;
Minor revision|CEP granted|11/03/2022;
Notification|Accepted - CEP remains valid|24/08/2020;
Major revision|CEP granted|02/07/2020
2176 Febantel for veterinary use MATRIX PHARMACORP PRIVATE LIMITED Sangareddy IN 100051463;100098142 CEP 2006-260 - Rev 07 2026/04/29 Valid Chemical 2026/04/29 Notification|CEP granted|29/04/2026;
Notification|CEP granted|17/09/2025;
Notification|CEP granted|22/07/2024;
Notification|CEP granted|01/09/2021
735 Prednisolone sodium phosphate HENAN LIHUA PHARMACEUTICAL CO., LTD. Anyang CN 100016183;100024971 CEP 2016-329 - Rev 01 2026/04/29 Valid Chemical 2026/04/29 Notification|CEP granted|29/04/2026;
Minor revision|Accepted - CEP remains valid|30/07/2024;
Renewal|CEP granted|13/07/2023
968 Aciclovir HUBEI YITAI PHARMACEUTICAL CO., LTD. Tianmen CN 100039319;100061892 CEP 2019-238 - Rev 02 2026/04/29 Valid Chemical 2026/04/29 Renewal|CEP granted|29/04/2026;
Minor revision|CEP granted|31/05/2022
780 Oxytocin ASPEN OSS B.V. Oss NL 100011619;100050602 CEP 2000-150 - Rev 05 2026/04/29 Valid Chemical 2026/04/29 Administrative procedure|CEP granted|29/04/2026;
Monograph revision|CEP granted|07/08/2023
1696 Flunixin meglumine for veterinary use ALIVIRA ANIMAL HEALTH LIMITED Visakhapatnam IN 100033528;100052489 CEP 2013-017 - Rev 05 2026/04/28 Valid Chemical 2026/04/28 Notification|CEP granted|28/04/2026;
Minor revision|Accepted - CEP remains valid|21/01/2025;
Minor revision|Accepted - CEP remains valid|03/05/2024;
Notification|CEP granted|30/03/2023;
Minor revision|CEP granted|16/09/2022;
Minor revision|Accepted - CEP remains valid|02/06/2021;
Minor revision|CEP granted|09/10/2020
1058 Vancomycin hydrochloride XELLIA PHARMACEUTICALS APS Copenhagen S DK 100004144;100002734 CEP 2007-195 - Rev 04 2026/04/28 Valid Chemical 2026/04/28 Minor revision|CEP granted|28/04/2026;
Minor revision|CEP granted|03/04/2025;
Minor revision|Accepted - CEP remains valid|14/03/2024;
Notification|Accepted - CEP remains valid|09/02/2023;
Minor revision|Accepted - CEP remains valid|16/02/2022;
Notification|Accepted - CEP remains valid|15/12/2020
2856 Pirfenidone SMS PHARMACEUTICALS LIMITED Hyderabad IN 100011780;100061058 CEP 2024-559 - Rev 00 2026/04/28 Valid 28/04/2031 Chemical 2026/04/28 New application|CEP granted|28/04/2026
1409 Clenbuterol Hydrochloride EDMOND PHARMA S.R.L. Paderno Dugnano IT 100000246;100002746 CEP 2012-073 - Rev 02 2026/04/28 Valid Chemical 2026/04/28 Monograph revision|CEP granted|28/04/2026
889 Clomipramine Hydrochloride SIGMA-ALDRICH IRELAND LTD Arklow IE 100019213;100027978 CEP 2008-269 - Rev 02 2026/04/28 Valid Chemical 2026/04/28 Minor revision|CEP granted|28/04/2026;
Minor revision|Accepted - CEP remains valid|19/07/2023
2574 Entacapone, Form-A, process-II NEULAND LABORATORIES LIMITED Hyderabad IN 100011545;100062134 CEP 2026-076 - Rev 00 2026/04/28 Valid 28/04/2031 Chemical 2026/04/28 New application|CEP granted|28/04/2026
632 Phenylephrine hydrochloride WUHAN WUYAO PHARMACEUTICAL CO., LTD. Huangshi CN 100022200;100030902 CEP 2024-587 - Rev 00 2026/04/28 Valid 28/04/2031 Chemical 2026/04/28 New application|CEP granted|28/04/2026
2905 Methane intermix (2 per cent) in nitrogen SOL S.P.A. Monza IT 100002061;100001723 CEP 2025-504 - Rev 00 2026/04/28 Valid 28/04/2031 Chemical 2026/04/28 New application|CEP granted|28/04/2026
2903 Acetylene intermix (1 per cent) in nitrogen SOL S.P.A. Monza IT 100002061;100001723 CEP 2025-626 - Rev 00 2026/04/28 Valid 28/04/2031 Chemical 2026/04/28 New application|CEP granted|28/04/2026
2675 Irinotecan hydrochloride trihydrate, Process-2 LAURUS LABS LIMITED Hyderabad IN 100011702;100101872 CEP 2025-394 - Rev 01 2026/04/28 Valid 14/10/2030 Chemical 2026/04/28 Minor revision|CEP granted|28/04/2026;
New application|CEP granted|14/10/2025
228 Lithium carbonate EMNAR PHARMA PRIVATE LIMITED Hyderabad IN 100033980;100065255 CEP 2026-037 - Rev 00 2026/04/28 Valid 28/04/2031 Chemical 2026/04/28 New application|CEP granted|28/04/2026
2644 Remifentanil hydrochloride HAMELN RDS S.R.O. Modra SK 100000646;100003437 CEP 2018-125 - Rev 05 2026/04/24 Valid Chemical 2026/04/24 Monograph revision|CEP granted|24/04/2026;
Renewal|CEP granted|20/03/2024;
Notification|Accepted - CEP remains valid|09/11/2021;
Notification|Accepted - CEP remains valid|16/09/2021;
Minor revision|CEP granted|02/06/2021;
Notification|CEP granted|27/11/2020;
Minor revision|CEP granted|24/03/2020

数据库说明:

当前数据更新日期:2026年05月22日。
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