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
1680 Pyrantel embonate IPCA LABORATORIES LIMITED Mumbai IN 100011685;100018680 CEP 2005-294 - Rev 03 2025/02/25 Valid Chemical 2025/02/25 Minor revision|CEP granted|25/02/2025;
Notification|Accepted - CEP remains valid|23/06/2023;
Minor revision|CEP granted|15/12/2020;
Monograph revision|Accepted - CEP remains valid|28/04/2020
2780 Temozolomide, Form-III HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2017-270 - Rev 02 2025/02/25 Valid Chemical 2025/02/25 Minor revision|CEP granted|25/02/2025;
Renewal|CEP granted|16/01/2024
2373 Meloxicam ARCH PHARMALABS LIMITED Mumbai IN 100011823;100095249 CEP 2019-283 - Rev 03 2025/02/25 Valid 02/09/2027 Chemical 2025/02/25 Notification|CEP granted|25/02/2025;
Minor revision|CEP granted|05/01/2024;
Notification|CEP granted|04/12/2023;
Minor revision|Accepted - CEP remains valid|24/10/2022
1794 Paclitaxel, Produced by a semi-synthetic process – Process II INDENA S.P.A. Milan IT 100006081;100011479 CEP 2019-346 - Rev 06 2025/02/25 Valid Chemical 2025/02/25 Renewal|CEP granted|25/02/2025;
Minor revision|CEP granted|11/07/2023;
Notification|CEP granted|05/10/2022;
Minor revision|CEP granted|05/09/2022;
Notification|Accepted - CEP remains valid|29/09/2021;
Minor revision|CEP granted|23/02/2021;
Notification|CEP granted|25/08/2020
2020 Rilmenidine dihydrogen phosphate ORIL INDUSTRIE Bolbec FR 100012082;100022735 CEP 2015-244 - Rev 01 2025/02/24 Valid Chemical 2025/02/24 Minor revision|CEP granted|24/02/2025;
Minor revision|Accepted - CEP remains valid|23/04/2024;
Renewal|CEP granted|29/10/2021
1722 Flunarizine dihydrochloride OLON S.P.A. Rodano IT 100012085;100019537 CEP 2004-264 - Rev 06 2025/02/24 Valid Chemical 2025/02/24 Minor revision|CEP granted|24/02/2025;
Monograph revision|CEP granted|04/08/2023;
Minor revision|Accepted - CEP remains valid|01/08/2022;
Minor revision|CEP granted|07/01/2021
693 Tretinoin OLON S.P.A. Rodano IT 100012085;100019537 CEP 1998-082 - Rev 08 2025/02/24 Valid Chemical 2025/02/24 Minor revision|CEP granted|24/02/2025;
Notification|Accepted - CEP remains valid|09/08/2022;
Minor revision|CEP granted|18/06/2021
1718 Diclazuril for veterinary use ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD. Shaoxing CN 100022562;100031241 CEP 2018-234 - Rev 04 2025/02/24 Valid Chemical 2025/02/24 Renewal|CEP granted|24/02/2025;
Notification|Accepted - CEP remains valid|05/06/2024;
Major revision|CEP granted|27/04/2023;
Monograph revision|CEP granted|10/01/2023;
Minor revision|CEP granted|07/04/2021
. Foetal Bovine Serum LIFE TECHNOLOGIES CORPORATION Carlsbad US 100050231;100093064 CEP 2000-089 - Rev 04 2025/02/24 Valid TSE 2025/02/24 Major revision|CEP granted|24/02/2025
2896 Thiocolchicoside crystallised from ethanol SARV BIO LABS PRIVATE LIMITED Sirmaur IN 100039294;100061855 CEP 2022-239 - Rev 00 2025/02/24 Valid 24/02/2030 Chemical 2025/02/24 New application|CEP granted|24/02/2025
2887 Raltegravir potassium LAURUS LABS LIMITED Hyderabad IN 100011702;100032608 CEP 2023-211 - Rev 00 2025/02/24 Valid 24/02/2030 Chemical 2025/02/24 New application|CEP granted|24/02/2025
1335 Itraconazole VASUDHA PHARMA CHEM LIMITED Hyderabad IN 100011811;100018603 CEP 2020-265 - Rev 03 2025/02/24 Valid 21/03/2027 Chemical 2025/02/24 Minor revision|CEP granted|24/02/2025;
Minor revision|Accepted - CEP remains valid|29/11/2023;
Notification|Rejected|28/09/2023;
Notification|CEP granted|03/02/2023;
Minor revision|CEP granted|01/07/2022;
New application|CEP granted|21/03/2022
50 Procaine Hydrochloride FLARER S.A. Balerna CH 100047920;100079248 CEP 2021-223 - Rev 02 2025/02/24 Valid 14/11/2027 Chemical 2025/12/03 Minor revision|Accepted - CEP remains valid|03/12/2025;
Minor revision|CEP granted|24/02/2025;
Minor revision|CEP granted|02/02/2024;
New application|CEP granted|14/11/2022
2593 Docetaxel, Process-2 LAURUS LABS LIMITED Hyderabad IN 100011702;100032608 CEP 2012-287 - Rev 02 2025/02/21 Valid Chemical 2025/02/21 Minor revision|CEP granted|21/02/2025;
Minor revision|CEP granted|20/01/2023
1286 Alfacalcidol CARBOGEN AMCIS B.V. Veenendaal NL 100002010;100009870 CEP 1998-097 - Rev 12 2025/02/21 Valid Chemical and TSE 2025/02/21 Administrative procedure|CEP granted|21/02/2025;
Administrative procedure|CEP granted|04/02/2025;
Minor revision|CEP granted|23/01/2025;
Notification|CEP granted|15/03/2023;
Notification|CEP granted|09/03/2022
2296 Pantoprazole sodium sesquihydrate MSN LIFE SCIENCES PRIVATE LIMITED Bhiknoor Village IN 100018316;100070723 CEP 2019-274 - Rev 01 2025/02/21 Valid Chemical 2025/02/21 Renewal|CEP granted|21/02/2025
2019 Perindopril tert-butylamine ZHEJIANG CHANGMING PHARMACEUTICAL CO., LTD. Taizhou CN 100022703;100031392 CEP 2023-355 - Rev 01 2025/02/21 Valid 21/01/2030 Chemical 2025/02/21 Notification|CEP granted|21/02/2025;
New application|CEP granted|21/01/2025
1472 Sodium hyaluronate, Intrinsic viscosity 2.3 m3/kg, by fermentation, for parenteral administration other than intra-articular administration and intra-ocular use SHANDONG FOCUSFREDA BIOTECH CO., LTD. Qufu CN 100053560;100094671 CEP 2021-388 - Rev 01 2025/02/20 Valid 07/06/2028 Chemical 2025/02/20 Minor revision|CEP granted|20/02/2025;
New application|CEP granted|07/06/2023
2064 Chondroitin sulfate sodium, Terrestrial origin ZPD A/S Esbjerg DK 100023030;100031772 CEP 2022-508 - Rev 01 2025/02/20 Valid 23/05/2029 Chemical and TSE 2025/02/20 Major revision|CEP granted|20/02/2025;
New application|CEP granted|23/05/2024
1035 Phenylephrine MALLADI DRUGS AND PHARMACEUTICALS LIMITED Ranipet IN 100017917;100027111 CEP 2018-142 - Rev 03 2025/02/20 Valid Chemical 2025/02/20 Renewal|CEP granted|20/02/2025;
Notification|CEP granted|13/09/2021;
Minor revision|CEP granted|09/04/2020

数据库说明:

当前数据更新日期:2025年12月08日。
©2006-2025 DrugFuture->Certificates of Suitability to the monographs of European Pharmacopoeia, EDQM