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
2443 Fulvestrant CHONGQING HUAPONT SHENGCHEM PHARMACEUTICAL CO., LTD. Chongqing CN 100024073;100062002 CEP 2025-060 - Rev 00 2026/05/04 Valid 04/05/2031 Chemical 2026/05/04 New application|CEP granted|04/05/2026
1048 Testosterone enantate SYMBIOTEC PHARMALAB LIMITED Indore IN 100018972;100095999 CEP 2025-080 - Rev 00 2026/05/04 Valid 04/05/2031 Chemical 2026/05/04 New application|CEP granted|04/05/2026
3132 Mirabegron SYNTHIMED LABS PRIVATE LIMITED Derabassi IN 100052287;100092080 CEP 2025-017 - Rev 00 2026/05/04 Valid 04/05/2031 Chemical 2026/05/04 New application|CEP granted|04/05/2026
1472 Sodium hyaluronate, Intrinsic viscosity 3.0 m3/kg, by fermentation, for parenteral administration including intra-articular administration and for intra-ocular use SHANDONG FOCUSFREDA BIOTECH CO., LTD. Qufu CN 100053560;100094671 CEP 2025-464 - Rev 00 2026/05/04 Valid 04/05/2031 Chemical 2026/05/04 New application|CEP granted|04/05/2026
2570 Desloratadine HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2016-065 - Rev 02 2026/04/30 Valid Chemical 2026/04/30 Minor revision|CEP granted|30/04/2026;
Minor revision|CEP granted|20/03/2024;
Renewal|CEP granted|20/06/2022
2416 Pramipexole dihydrochloride monohydrate ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 CEP 2011-190 - Rev 01 2026/04/30 Valid Chemical 2026/04/30 Minor revision|CEP granted|30/04/2026;
Minor revision|Accepted - CEP remains valid|27/09/2024;
Minor revision|Accepted - CEP remains valid|26/01/2024;
Minor revision|Accepted - CEP remains valid|03/01/2023;
Minor revision|Accepted - CEP remains valid|12/07/2022
2815 Entecavir monohydrate HETERO DRUGS LIMITED Hyderabad IN 100008415;100014434 CEP 2017-271 - Rev 06 2026/04/30 Valid Chemical 2026/04/30 Minor revision|CEP granted|30/04/2026;
Notification|CEP granted|19/05/2025;
Renewal|CEP granted|10/06/2024;
Minor revision|CEP granted|28/07/2023;
Minor revision|CEP granted|22/09/2020
2600 Olmesartan medoxomil CHIERON ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN 100053345;100094249 CEP 2018-232 - Rev 03 2026/04/30 Valid Chemical 2026/04/30 Major revision|CEP granted|30/04/2026;
Renewal|CEP granted|11/07/2025;
Minor revision|Accepted - CEP remains valid|20/09/2022;
Major revision|CEP granted|08/07/2021;
Minor revision|Rejected|22/02/2021
1773 Cabergoline LIFECARE LABORATORIES PRIVATE LIMITED Hyderabad IN 100049798;100086853 CEP 2023-093 - Rev 01 2026/04/30 Valid 12/03/2031 Chemical 2026/04/30 Minor revision|CEP granted|30/04/2026;
New application|CEP granted|12/03/2026
943 Oxymetazoline hydrochloride COHANCE LIFESCIENCES LIMITED Mumbai IN 100011755;100090273 CEP 2025-091 - Rev 00 2026/04/30 Valid 30/04/2031 Chemical 2026/04/30 New application|CEP granted|30/04/2026
1974 Clobazam, Micronised LAKE CHEMICALS PRIVATE LIMITED Bengaluru IN 100012055;100053935 CEP 2024-173 - Rev 00 2026/04/30 Valid 30/04/2031 Chemical 2026/04/30 New application|CEP granted|30/04/2026
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

数据库说明:

当前数据更新日期:2026年05月27日。
©2006-2026 DrugFuture->Certificates of Suitability to the monographs of European Pharmacopoeia, EDQM