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
29 Imipramine hydrochloride TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL 100000702;100060842 CEP 2002-051 - Rev 04 2024/01/30 Valid Chemical 2024/01/30 Minor revision|CEP granted|30/01/2024;
Minor revision|CEP granted|24/02/2022;
Notification|Accepted - CEP remains valid|14/12/2020
2232 Losartan potassium SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN 100008538;100018201 CEP 2010-255 - Rev 04 2024/01/30 Valid Chemical 2024/01/30 Minor revision|CEP granted|30/01/2024;
Monograph revision|CEP granted|22/06/2023
2531 Clopidogrel hydrogen sulfate ZENJI PHARMACEUTICALS SUZHOU LTD. Xuguan, Suzhou CN 100039179;100061666 CEP 2021-230 - Rev 00 2024/01/30 Valid 30/01/2029 Chemical 2024/01/30 New application|CEP granted|30/01/2024
2815 Entecavir monohydrate SCINOPHARM TAIWAN, LTD. Shan-Hua TW 100012108;100019515 CEP 2017-001 - Rev 01 2024/01/30 Valid Chemical 2024/01/30 Renewal|CEP granted|30/01/2024
1756 Lamotrigine ZYDUS LIFESCIENCES LIMITED Vadodara IN 100005979;100074301 CEP 2018-295 - Rev 03 2024/01/30 Valid 17/03/2026 Chemical 2024/01/30 Minor revision|CEP granted|30/01/2024;
Minor revision|Accepted - CEP remains valid|24/04/2023;
Minor revision|CEP granted|02/12/2022;
Notification|CEP granted|08/07/2022
2230 Latanoprost KYOWA PHARMA CHEMICAL CO., LTD. Takaoka JP 100012459;100023014 CEP 2022-107 - Rev 01 2024/01/29 Valid 23/11/2028 Chemical 2024/11/26 Minor revision|Accepted - CEP remains valid|26/11/2024;
Administrative procedure|CEP granted|29/01/2024;
New application|CEP granted|23/11/2023
2119 Venlafaxine hydrochloride ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN 100006039;100002980 CEP 2006-225 - Rev 05 2024/01/29 Valid Chemical 2024/08/22 Minor revision|Accepted - CEP remains valid|22/08/2024;
Minor revision|CEP granted|29/01/2024;
Minor revision|Accepted - CEP remains valid|19/06/2020
57 Tetracaine hydrochloride SIEGFRIED EVIONNAZ SA Evionnaz CH 100011796;100019013 CEP 2017-205 - Rev 01 2024/01/29 Valid Chemical 2024/01/29 Renewal|CEP granted|29/01/2024;
Monograph revision|Accepted - CEP remains valid|21/03/2022
2535 Levetiracetam, Process II SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN 100023303;100032437 CEP 2021-267 - Rev 01 2024/01/29 Valid 29/10/2026 Chemical 2024/10/10 Minor revision|Accepted - CEP remains valid|10/10/2024;
Notification|CEP granted|29/01/2024;
Minor revision|Accepted - CEP remains valid|08/06/2022;
New application|CEP granted|29/10/2021
2585 Rizatriptan benzoate EMCURE PHARMACEUTICALS LIMITED Pune IN 100011677;100022645 CEP 2019-095 - Rev 01 2024/01/29 Valid 18/02/2026 Chemical 2024/01/29 Minor revision|CEP granted|29/01/2024
750 Glutamic Acid EVONIK REXIM S.A.S. Ham FR 100012329;100020964 CEP 2009-311 - Rev 01 2024/01/29 Valid Chemical 2024/01/29 Minor revision|CEP granted|29/01/2024
1563 Simvastatin SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN 100023303;100032437 CEP 2005-300 - Rev 06 2024/01/26 Valid Chemical and TSE 2024/04/23 Minor revision|Rejected|23/04/2024;
Notification|CEP granted|26/01/2024;
Minor revision|Accepted - CEP remains valid|28/10/2022;
Minor revision|CEP granted|18/06/2021
2535 Levetiracetam SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN 100023303;100032437 CEP 2014-139 - Rev 01 2024/01/26 Valid Chemical 2024/01/26 Notification|CEP granted|26/01/2024;
Minor revision|Accepted - CEP remains valid|04/04/2022;
Renewal|CEP granted|27/01/2021
1563 Simvastatin BIOCON LIMITED Bengaluru IN 100011487;100018595 CEP 2012-337 - Rev 03 2024/01/26 Valid Chemical 2024/01/26 Notification|CEP granted|26/01/2024;
Minor revision|Accepted - CEP remains valid|16/03/2023;
Minor revision|CEP granted|04/06/2020
2631 Rosuvastatin calcium SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN 100023303;100032437 CEP 2019-309 - Rev 02 2024/01/26 Valid 15/01/2026 Chemical 2024/03/14 Minor revision|Accepted - CEP remains valid|14/03/2024;
Notification|CEP granted|26/01/2024;
Minor revision|CEP granted|26/10/2023;
Minor revision|Accepted - CEP remains valid|03/10/2022
2598 Levofloxacin hemihydrate SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN 100023303;100032437 CEP 2020-041 - Rev 02 2024/01/26 Valid 16/06/2026 Chemical 2024/04/24 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
3087 Ticagrelor SHAOXING JINGXIN PHARMACEUTICAL CO., LTD. Shangyu CN 100023303;100032437 CEP 2022-187 - Rev 01 2024/01/26 Valid 09/06/2028 Chemical 2024/07/29 Minor revision|Accepted - CEP remains valid|29/07/2024;
Notification|CEP granted|26/01/2024;
New application|CEP granted|09/06/2023
673 Medroxyprogesterone acetate CURIA SPAIN S.A.U. Boecillo ES 100011649;100019586 CEP 2022-311 - Rev 00 2024/01/26 Valid 26/01/2029 Chemical 2024/01/26 New application|CEP granted|26/01/2024
1002 Diclofenac sodium AARTI DRUGS LIMITED Mumbai IN 100014953;100023652 CEP 2021-246 - Rev 00 2024/01/26 Valid 26/01/2029 Chemical 2024/01/26 New application|CEP granted|26/01/2024
141 Ethionamide Pen Tsao Chemical Industry Ltd Hong Kong SAR CN 100024181;100088240 CEP 2021-172 - Rev 00 2024/01/26 Valid 26/01/2029 Chemical 2024/01/26 New application|CEP granted|26/01/2024

数据库说明:

当前数据更新日期:2024年12月22日。
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