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
1783 Glycopyrronium bromide FDC Limited Mumbai IN 100011646;100021030 CEP 2024-110 - Rev 00 2025/03/28 Valid 28/03/2030 Chemical 2025/03/28 New application|CEP granted|28/03/2025
2535 Levetiracetam ZHEJIANG CHANGMING PHARMACEUTICAL CO., LTD. Taizhou CN 100022703;100031392 CEP 2012-072 - Rev 01 2025/03/27 Withdrawn by Holder 2025/06/04 Chemical 2025/03/27
1724 Formoterol fumarate dihydrate, Micronised, non-micronised Inke, S.A. Castellbisbal ES 100020253;100029013 CEP 2006-024 - Rev 03 2025/03/27 Valid Chemical 2025/03/27 Minor revision|CEP granted|27/03/2025;
Monograph revision|Accepted - CEP remains valid|06/05/2022;
Minor revision|CEP granted|15/10/2020
1368 Ramipril ZHEJIANG CHANGMING PHARMACEUTICAL CO., LTD. Taizhou CN 100022703;100031392 CEP 2010-176 - Rev 01 2025/03/27 Valid Chemical 2025/03/27 Notification|CEP granted|27/03/2025
311 Aluminium oxide, hydrated, 0200 SPI PHARMA, INC. Wilmington US 100018352;100042876 CEP 2008-264 - Rev 01 2025/03/26 Valid Chemical 2025/03/26 Monograph revision|CEP granted|26/03/2025
1081 Carboplatin SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2003-155 - Rev 04 2025/03/26 Valid Chemical 2025/03/26 Major revision|CEP granted|26/03/2025;
Minor revision|CEP granted|14/12/2023
734 Prednisolone acetate EUROAPI FRANCE Vertolaye FR 100039327;100061906 CEP 2000-025 - Rev 07 2025/03/26 Valid Chemical 2025/03/26 Minor revision|CEP granted|26/03/2025;
Transfer of holdership|CEP granted|16/12/2021;
Minor revision|CEP granted|04/06/2020
293 Spiramycin EUROAPI ITALY S.R.L. Brindisi IT 100039217;100061735 CEP 2010-032 - Rev 04 2025/03/26 Valid Chemical and TSE 2025/12/03 Notification|Accepted - CEP remains valid|03/12/2025;
Minor revision|CEP granted|26/03/2025;
Notification|Accepted - CEP remains valid|04/07/2024;
Transfer of holdership|CEP granted|17/12/2021;
Notification|CEP granted|09/11/2020;
Notification|CEP granted|24/03/2020
1188 Cefixime QILU ANTIBIOTICS PHARMACEUTICAL CO. LTD. Jinan CN 100033695;100052910 CEP 2014-213 - Rev 01 2025/03/26 Valid Chemical 2025/03/26 Minor revision|CEP granted|26/03/2025;
Minor revision|Accepted - CEP remains valid|10/05/2022;
Renewal|CEP granted|19/02/2021
1368 Ramipril, Process-II HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2021-281 - Rev 01 2025/03/26 Valid 20/05/2027 Chemical 2025/08/21 Minor revision|Accepted - CEP remains valid|21/08/2025;
Minor revision|CEP granted|26/03/2025;
Minor revision|Accepted - CEP remains valid|13/02/2023;
New application|CEP granted|20/05/2022
1472 Sodium hyaluronate, Intrinsic viscosity 1.28 m3/kg; 1.63 m3/kg, by fermentation, for parenteral administration including intra-articular administration and for intra-ocular use KEWPIE CORP. Tokyo JP 100039277;100093553 CEP 2018-037 - Rev 03 2025/03/26 Valid Chemical and TSE 2025/03/26 Notification|CEP granted|26/03/2025;
Renewal|CEP granted|21/02/2025;
Minor revision|Accepted - CEP remains valid|11/08/2022;
Minor revision|CEP granted|24/03/2021
1589 Doxylamine hydrogen succinate, Grade II R L FINE CHEM PVT. LTD. Gowribidanur IN 100016723;100053383 CEP 2021-283 - Rev 02 2025/03/26 Valid 25/10/2026 Chemical 2025/03/26 Minor revision|CEP granted|26/03/2025;
Minor revision|CEP granted|08/02/2024;
New application|CEP granted|25/10/2021
1444 Macrogols, Type 3350 and 4000 LIAONING OXIRANPHARM INC. Liaoyang CN 100051050;100089345 CEP 2024-418 - Rev 00 2025/03/26 Valid 26/03/2030 Chemical 2025/03/26 New application|CEP granted|26/03/2025
1407 Ciclopirox SHANGHAI PHARMA GROUP CHANGZHOU KONY PHARMACEUTICAL CO., LTD. Luoyang Town CN 100020594;100034407 CEP 2019-102 - Rev 02 2025/03/25 Valid Chemical 2025/03/25 Renewal|CEP granted|25/03/2025;
Minor revision|Accepted - CEP remains valid|06/09/2024;
Notification|CEP granted|22/07/2020
294 Sulfadiazine CHONGQING KANGLE PHARMACEUTICAL CO., LTD. Chongqing City CN 100024105;100033269 CEP 2019-042 - Rev 02 2025/03/25 Valid Chemical 2025/03/25 Renewal|CEP granted|25/03/2025;
Minor revision|CEP granted|09/01/2023
2858 Mometasone furoate monohydrate, Micronised AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN 100045727;100075371 CEP 2018-303 - Rev 03 2025/03/25 Valid Chemical 2025/03/25 Renewal|CEP granted|25/03/2025;
Notification|Accepted - CEP remains valid|23/06/2023;
Notification|CEP granted|20/10/2022;
Minor revision|CEP granted|15/09/2021
311 Aluminium oxide, hydrated, 0325 SPI PHARMA, INC. Wilmington US 100018352;100042876 CEP 2008-270 - Rev 01 2025/03/25 Valid Chemical 2025/03/25 Monograph revision|CEP granted|25/03/2025
2414 Octreotide SINOPEP-ALLSINO BIOPHARMACEUTICAL CO., LTD. Lianyungang CN 100034355;100054452 CEP 2022-302 - Rev 01 2025/03/25 Valid 21/06/2029 Chemical 2025/03/25 Minor revision|CEP granted|25/03/2025;
New application|CEP granted|21/06/2024
1012 Famotidine Union Quimico Farmaceutica, S.A. (Uquifa S.A.) Barcelona ES 100000721;100001301 CEP 2021-182 - Rev 01 2025/03/25 Valid 08/06/2028 Chemical 2025/03/25 Minor revision|CEP granted|25/03/2025;
New application|CEP granted|08/06/2023
582 Clindamycin hydrochloride, Process C CHONGQING CARELIFE PHARMACEUTICAL CO., LTD. Chongqing CN 100011995;100018631 CEP 2024-484 - Rev 00 2025/03/25 Valid 25/03/2030 Chemical 2025/03/25 New application|CEP granted|25/03/2025

数据库说明:

当前数据更新日期:2025年12月10日。
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