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
2059 Pravastatin sodium TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2003-073 - Rev 04 2025/02/28 Valid Chemical 2025/02/28 Notification|CEP granted|28/02/2025;
Minor revision|Accepted - CEP remains valid|25/10/2024;
Minor revision|CEP granted|25/02/2022;
Minor revision|Accepted - CEP remains valid|29/09/2020
1241 Mefloquine hydrochloride OLON S.P.A. Rodano IT 100012085;100019537 CEP 2011-099 - Rev 05 2025/02/28 Valid Chemical 2025/02/28 Minor revision|CEP granted|28/02/2025;
Monograph revision|CEP granted|11/07/2024;
Minor revision|Accepted - CEP remains valid|18/12/2023;
Monograph revision|CEP granted|12/04/2023;
Minor revision|Accepted - CEP remains valid|15/07/2022;
Minor revision|CEP granted|30/03/2021
551 Dihydroergotamine mesilate TAPI CZECH INDUSTRIES S.R.O. Opava CZ 100051642;100090678 CEP 2005-107 - Rev 03 2025/02/28 Valid Chemical 2025/02/28 Minor revision|CEP granted|28/02/2025;
Minor revision|CEP granted|07/11/2022;
Minor revision|Accepted - CEP remains valid|25/11/2021;
Minor revision|Accepted - CEP remains valid|15/12/2020
2232 Losartan potassium ZYDUS LIFESCIENCES LIMITED Vadodara IN 100005979;100074301 CEP 2009-133 - Rev 09 2025/02/28 Valid Chemical 2025/06/19 Minor revision|Accepted - CEP remains valid|19/06/2025;
Minor revision|CEP granted|28/02/2025;
Minor revision|CEP granted|23/03/2023;
Minor revision|Accepted - CEP remains valid|04/01/2023;
Minor revision|Accepted - CEP remains valid|30/08/2022;
Notification|CEP granted|07/07/2022;
Major revision|CEP granted|03/01/2022;
Minor revision|CEP granted|15/01/2021;
Minor revision|CEP granted|11/06/2020
2541 Quetiapine Fumarate, Standard and milled Moehs Iberica S.L. Rubi ES 100029092;100068825 CEP 2018-277 - Rev 03 2025/02/28 Valid Chemical 2025/03/03 Renewal|CEP granted|03/03/2025;
Major revision|CEP granted|21/11/2024;
Minor revision|CEP granted|03/05/2021
2191 Atorvastatin calcium ARCH PHARMALABS LIMITED Mumbai IN 100011823;100095249 CEP 2019-129 - Rev 03 2025/02/28 Valid 02/12/2026 Chemical 2025/03/03 Notification|CEP granted|03/03/2025;
Minor revision|CEP granted|09/02/2024;
Notification|CEP granted|04/12/2023;
Minor revision|Accepted - CEP remains valid|03/11/2022;
Monograph revision|Accepted - CEP remains valid|22/08/2022
140 Ethinylestradiol, Micronised, non-micronised QINHUANGDAO ZIZHU PHARMACEUTICAL CO., LTD. Qinhuangdao City CN 100016470;100025257 CEP 2011-220 - Rev 02 2025/02/28 Valid Chemical 2025/08/25 Notification|Accepted - CEP remains valid|25/08/2025;
Notification|CEP granted|03/03/2025;
Minor revision|CEP granted|25/08/2020
1146 Roxithromycin HEC PHARM CO., LTD. Yidu City CN 100017619;100026390 CEP 2018-207 - Rev 01 2025/02/28 Valid Chemical 2025/03/03 Renewal|CEP granted|03/03/2025
2591 Celecoxib AARTI DRUGS LIMITED Mumbai IN 100014953;100023652 CEP 2014-199 - Rev 01 2025/02/28 Valid Chemical 2025/03/03 Minor revision|CEP granted|03/03/2025;
Renewal|CEP granted|23/08/2021
1745 Carvedilol, Process-II, micronised APITORIA PHARMA PRIVATE LIMITED Hyderabad IN 100049668;100086364 CEP 2024-534 - Rev 00 2025/02/28 Valid 28/02/2030 Chemical 2025/03/03 New application|CEP granted|03/03/2025
1275 Ursodeoxycholic acid SUZHOU TIANLU BIO-PHARMACEUTICAL CO. LTD. Suzhou CN 100018634;100027427 CEP 2023-317 - Rev 01 2025/02/28 Valid 07/02/2030 Chemical 2025/03/03 Administrative procedure|CEP granted|03/03/2025;
New application|CEP granted|07/02/2025
2743 Zoledronic acid monohydrate TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2020-018 - Rev 02 2025/02/28 Valid 11/06/2026 Chemical 2025/03/03 Minor revision|CEP granted|03/03/2025;
Notification|Rejected|27/01/2025;
Notification|CEP granted|14/01/2022;
New application|CEP granted|11/06/2021
3035 Tapentadol hydrochloride YICHANG HUMANWELL PHARMACEUTICAL CO., LTD. Yichang CN 100023502;100032643 CEP 2024-119 - Rev 00 2025/02/28 Valid 28/02/2030 Chemical 2025/03/03 New application|CEP granted|03/03/2025
353 Prednisolone, Micronised SYMBIOTEC PHARMALAB PRIVATE LIMITED Indore IN 100018972;100027743 CEP 2020-194 - Rev 01 2025/02/28 Valid 23/06/2027 Chemical 2025/03/03 Minor revision|CEP granted|03/03/2025;
New application|CEP granted|23/06/2022
38 Levodopa, Enzymatic process TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2013-293 - Rev 02 2025/02/27 Valid Chemical 2025/02/27 Notification|CEP granted|27/02/2025;
Notification|CEP granted|22/11/2021;
Renewal|CEP granted|26/05/2020
1450 Mupirocin, Isobutyl acetate process TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2017-011 - Rev 01 2025/02/27 Valid Chemical 2025/02/27 Notification|CEP granted|27/02/2025;
Minor revision|Accepted - CEP remains valid|28/08/2023;
Renewal|CEP granted|02/06/2022;
Notification|CEP granted|23/11/2021;
Minor revision|Accepted - CEP remains valid|13/08/2021;
Minor revision|Accepted - CEP remains valid|09/10/2020
645 Tobramycin TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 1997-046 - Rev 07 2025/02/27 Valid Chemical 2025/02/27 Notification|CEP granted|27/02/2025;
Minor revision|Accepted - CEP remains valid|17/11/2023;
Minor revision|CEP granted|08/12/2021;
Minor revision|Accepted - CEP remains valid|07/12/2020
485 Dihydrostreptomycin sulfate for veterinary use North China Pharmaceutical Huasheng Co., Ltd. Shijiazhuang CN 100021261;100029965 CEP 2001-393 - Rev 08 2025/02/27 Valid Chemical 2025/02/27 Administrative procedure|CEP granted|27/02/2025;
Minor revision|CEP granted|13/02/2025;
Minor revision|CEP granted|28/06/2023;
Minor revision|Accepted - CEP remains valid|13/01/2021
394 Hydrochlorothiazide TAPI NL B.V. Amsterdam NL 100003852;100094134 CEP 2004-149 - Rev 08 2025/02/26 Valid Chemical 2025/02/26 Minor revision|CEP granted|26/02/2025;
Minor revision|CEP granted|03/10/2022;
Notification|CEP granted|22/11/2021;
Minor revision|Accepted - CEP remains valid|26/07/2021;
Notification|Accepted - CEP remains valid|05/01/2021
2284 Calcipotriol monohydrate CERBIOS-PHARMA SA Barbengo CH 100015546;100024284 CEP 2016-206 - Rev 02 2025/02/26 Valid Chemical 2025/02/26 Minor revision|CEP granted|26/02/2025;
Minor revision|CEP granted|30/11/2022;
Renewal|CEP granted|23/09/2022;
Administrative procedure|CEP granted|24/11/2021;
Minor revision|CEP granted|08/11/2021

数据库说明:

当前数据更新日期:2025年12月08日。
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