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
2931 Sorafenib tosilate BDR LIFESCIENCES PRIVATE LIMITED Luna Village IN 100034093;100053921 CEP 2022-478 - Rev 01 2025/06/23 Valid 06/11/2029 Chemical 2025/06/23 Monograph revision|CEP granted|23/06/2025;
New application|CEP granted|06/11/2024
1647 Lactobionic acid GLOBAL CALCIUM PRIVATE LIMITED Hosur IN 100020125;100028859 CEP 2018-164 - Rev 01 2025/06/20 Valid Chemical 2025/06/20 Renewal|CEP granted|20/06/2025
1092 Cyclizine Hydrochloride MICRO LABS LIMITED Bengaluru IN 100017819;100077269 CEP 2010-355 - Rev 04 2025/06/20 Valid Chemical 2025/06/20 Minor revision|CEP granted|20/06/2025;
Minor revision|Accepted - CEP remains valid|07/12/2020
884 Carbimazole CURIA FRANCE S.A.S. Bon-Encontre FR 100040782;100067084 CEP 2019-078 - Rev 02 2025/06/20 Valid Chemical 2025/06/20 Renewal|CEP granted|20/06/2025;
Minor revision|Accepted - CEP remains valid|25/04/2024;
Minor revision|Accepted - CEP remains valid|28/04/2023;
Minor revision|CEP granted|26/08/2021
2244 Tacrolimus monohydrate BIOCON LIMITED Bengaluru IN 100011487;100018595 CEP 2017-257 - Rev 02 2025/06/20 Valid Chemical 2025/06/20 Minor revision|CEP granted|20/06/2025;
Notification|Accepted - CEP remains valid|04/03/2024;
Minor revision|CEP granted|29/11/2023;
Renewal|CEP granted|15/03/2023;
Major revision|CEP granted|12/12/2022;
Major revision|Rejected|20/10/2022;
Minor revision|Accepted - CEP remains valid|10/03/2022;
Minor revision|Accepted - CEP remains valid|09/06/2021;
Minor revision|CEP granted|23/09/2020
1352 Omega-3-acid triglycerides, Containing alpha tocopherol as antioxidant BASF AS Oslo NO 100003052;100032709 CEP 2017-298 - Rev 05 2025/06/20 Valid Chemical 2025/06/20 Minor revision|CEP granted|20/06/2025;
Renewal|CEP granted|21/08/2024;
Notification|Accepted - CEP remains valid|25/07/2023;
Monograph revision|Accepted - CEP remains valid|06/01/2021;
Minor revision|CEP granted|18/05/2020;
Notification|CEP granted|28/01/2020
330 Gelatin, Alkaline hide gelatin SHANDONG HENGXIN BIOTECH CO., LTD. Binzhou City CN 100054241;100096001 CEP 2020-191 - Rev 01 2025/06/20 Valid TSE 2025/06/20 Renewal|CEP granted|20/06/2025;
New application|CEP granted|30/11/2020
568 Propranolol hydrochloride MANKIND PHARMA LIMITED New Delhi IN 100040218;100065486 CEP 2021-104 - Rev 01 2025/06/20 Valid 30/08/2028 Chemical 2025/06/20 Notification|CEP granted|20/06/2025;
New application|CEP granted|30/08/2023
3087 Ticagrelor MANKIND PHARMA LIMITED New Delhi IN 100040218;100065486 CEP 2022-067 - Rev 01 2025/06/20 Valid 06/07/2028 Chemical 2025/06/20 Notification|CEP granted|20/06/2025;
New application|CEP granted|06/07/2023
101 Nitrofurantoin, Macrocrystals (Process-II) MANKIND PHARMA LIMITED New Delhi IN 100040218;100065486 CEP 2021-371 - Rev 01 2025/06/20 Valid 10/12/2026 Chemical 2025/06/20 Notification|CEP granted|20/06/2025;
New application|CEP granted|10/12/2021
889 Clomipramine Hydrochloride MANKIND PHARMA LIMITED New Delhi IN 100040218;100065486 CEP 2020-310 - Rev 01 2025/06/20 Valid 24/10/2027 Chemical 2025/06/20 Notification|CEP granted|20/06/2025;
New application|CEP granted|24/10/2022
687 Salbutamol sulfate, Process III, Non-micronised and Micronised CIPLA LIMITED Mumbai IN 100006004;100018147 CEP 2025-002 - Rev 00 2025/06/20 Valid 20/06/2030 Chemical 2025/06/20 New application|CEP granted|20/06/2025
560 Methotrexate RAVI BIOLIFE PRIVATE LTD. Mumbai IN 100048404;100086771 CEP 2024-257 - Rev 00 2025/06/20 Valid 20/06/2030 Chemical 2025/06/20 New application|CEP granted|20/06/2025
1466 Prazepam F.I.S. - FABBRICA ITALIANA SINTETICI S.P.A. Montecchio Maggiore IT 100011866;100022277 CEP 2023-291 - Rev 00 2025/06/20 Valid 20/06/2030 Chemical 2025/06/20 New application|CEP granted|20/06/2025
101 Nitrofurantoin, Macrocrystals ASOLUTION PHARMACEUTICALS PVT. LTD. Thane IN 100043528;100072005 CEP 2023-346 - Rev 00 2025/06/19 Valid 19/06/2030 Chemical 2025/06/19 New application|CEP granted|19/06/2025
1765 Salmeterol xinafoate, Micronised, non-micronised AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN 100045727;100075371 CEP 2008-239 - Rev 05 2025/06/19 Valid Chemical 2025/06/19 Minor revision|CEP granted|19/06/2025;
Notification|CEP granted|14/10/2022;
Notification|CEP granted|25/11/2021;
Minor revision|CEP granted|15/07/2021
2125 Doxazosin mesilate NOSCH LABS PRIVATE LIMITED Hyderabad IN 100020550;100029297 CEP 2023-154 - Rev 00 2025/06/19 Valid 19/06/2030 Chemical 2025/06/19 New application|CEP granted|19/06/2025
1188 Cefixime, Process 2 QILU ANTIBIOTICS PHARMACEUTICAL CO. LTD. Jinan CN 100033695;100052910 CEP 2021-361 - Rev 01 2025/06/19 Valid 09/12/2026 Chemical 2025/06/19 Minor revision|CEP granted|19/06/2025;
Major revision|Accepted - CEP remains valid|12/05/2022;
New application|CEP granted|09/12/2021
1248 Norfloxacin ZHEJIANG LEPU PHARMACEUTICAL CO., LTD Taizhou City CN 100033518;100052465 CEP 2006-037 - Rev 05 2025/06/19 Valid Chemical 2025/06/19 Minor revision|CEP granted|19/06/2025;
Minor revision|Accepted - CEP remains valid|12/11/2024;
Minor revision|CEP granted|20/02/2024;
Notification|CEP granted|16/08/2021;
Monograph revision|CEP granted|15/07/2021
1653 Potassium clavulanate, diluted, with silica, colloidal hydrated (0738) in ratio 1:1 SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD Datong CN 100033465;100082197 CEP 2014-329 - Rev 01 2025/06/18 Valid Chemical 2025/06/18 Minor revision|CEP granted|18/06/2025;
Renewal|CEP granted|03/03/2021

数据库说明:

当前数据更新日期:2026年02月12日。
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