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
871 Acebutolol hydrochloride NURAY CHEMICALS PRIVATE LIMITED Thiruvallur IN 100048890;100081754 CEP 2024-109 - Rev 00 2025/11/26 Valid 26/11/2030 Chemical 2025/11/26 New application|CEP granted|26/11/2025
2888 Rupatadine fumarate HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2024-294 - Rev 01 2025/11/26 Valid 10/09/2030 Chemical 2025/11/26 Minor revision|CEP granted|26/11/2025;
New application|CEP granted|10/09/2025
2992 Lacosamide VASUDHA PHARMA CHEM LIMITED Hyderabad IN 100011811;100018603 CEP 2024-405 - Rev 00 2025/11/26 Valid 26/11/2030 Chemical 2025/11/26 New application|CEP granted|26/11/2025
2768 Fluticasone furoate, Micronised VAMSI LABS LIMITED Solapur IN 100014747;100096958 CEP 2024-298 - Rev 00 2025/11/26 Valid 26/11/2030 Chemical 2025/11/26 New application|CEP granted|26/11/2025
2097 Mebeverine hydrochloride VASUDHA PHARMA CHEM LIMITED Hyderabad IN 100011811;100018603 CEP 2024-278 - Rev 00 2025/11/26 Valid 26/11/2030 Chemical 2025/11/26 New application|CEP granted|26/11/2025
2790 Clopidogrel besilate SYNTHIMED LABS PRIVATE LIMITED Derabassi IN 100052287;100092080 CEP 2024-347 - Rev 00 2025/11/26 Valid 26/11/2030 Chemical 2025/11/26 New application|CEP granted|26/11/2025
2306 Gemcitabine hydrochloride, Process-3 LAURUS LABS LIMITED Hyderabad IN 100011702;100032608 CEP 2025-445 - Rev 00 2025/11/26 Valid 26/11/2030 Chemical 2025/11/26 New application|CEP granted|26/11/2025
2765 Eplerenone, Form-L Site-II HETERO LABS LIMITED Hyderabad IN 100011681;100018664 CEP 2025-487 - Rev 00 2025/11/26 Valid 26/11/2030 Chemical 2025/11/26 New application|CEP granted|26/11/2025
1394 Bezafibrate DEVI PHARMATECH PRIVATE LIMITED Visakhapatnam IN 100053267;100094028 CEP 2024-541 - Rev 00 2025/11/26 Valid 26/11/2030 Chemical 2025/11/26 New application|CEP granted|26/11/2025
1804 Hydroxypropylbetadex, Molar substitution (MS) 0.7 ZIBO QIANHUI BIOLOGICAL TECHNOLOGY CO., LTD. Zibo City CN 100046161;100076158 CEP 2024-542 - Rev 00 2025/11/26 Valid 26/11/2030 Chemical 2025/11/26 New application|CEP granted|26/11/2025
1486 Adenosine PHARMA WALDHOF GMBH Duesseldorf DE 100035710;100056564 CEP 2025-070 - Rev 00 2025/11/26 Valid 26/11/2030 Chemical 2025/11/26 New application|CEP granted|26/11/2025
1386 Albendazole SEQUENT SCIENTIFIC LIMITED Hyderabad IN 100017805;100096208 CEP 2005-010 - Rev 07 2025/11/24 Valid Chemical 2025/11/24 Minor revision|CEP granted|24/11/2025;
Minor revision|CEP granted|20/03/2025;
Minor revision|CEP granted|20/12/2024;
Notification|Rejected|25/11/2024;
Minor revision|CEP granted|24/07/2024;
Minor revision|Accepted - CEP remains valid|29/09/2021;
Minor revision|CEP granted|21/12/2020
889 Clomipramine Hydrochloride BIOPHORE INDIA PHARMACEUTICALS PRIVATE LIMITED Hyderabad IN 100028906;100063062 CEP 2017-288 - Rev 02 2025/11/24 Valid Chemical 2025/11/24 Renewal|CEP granted|24/11/2025;
Notification|CEP granted|15/05/2023
1681 Tramadol hydrochloride VIRUPAKSHA ORGANICS LIMITED Hyderabad IN 100021606;100076961 CEP 2015-203 - Rev 03 2025/11/24 Valid Chemical 2025/11/24 Minor revision|CEP granted|24/11/2025;
Minor revision|CEP granted|25/07/2023;
Minor revision|CEP granted|27/03/2023;
Renewal|CEP granted|23/09/2021
2531 Clopidogrel hydrogen sulfate AARTI DRUGS LIMITED Mumbai IN 100014953;100023652 CEP 2019-104 - Rev 02 2025/11/24 Valid Chemical 2025/11/24 Renewal|CEP granted|24/11/2025;
Minor revision|CEP granted|26/01/2023
2762 Capecitabine, Process II INTAS PHARMACEUTICALS LIMITED Ahmedabad IN 100011529;100023432 CEP 2019-143 - Rev 02 2025/11/24 Valid Chemical 2025/11/24 Renewal|CEP granted|24/11/2025;
Transfer of holdership|CEP granted|27/06/2022
942 Omeprazole NOSCH LABS PRIVATE LIMITED Hyderabad IN 100020550;100029297 CEP 2019-339 - Rev 01 2025/11/24 Valid Chemical 2025/11/24 Renewal|CEP granted|24/11/2025
780 Oxytocin PIRAMAL PHARMA LIMITED Navi Mumbai IN 100036948;100075608 CEP 2008-029 - Rev 05 2025/11/24 Valid Chemical 2025/11/24 Major revision|CEP granted|24/11/2025;
Minor revision|Accepted - CEP remains valid|16/06/2025;
Minor revision|Accepted - CEP remains valid|07/03/2024;
Notification|Rejected|02/01/2024;
Monograph revision|CEP granted|03/11/2023;
Notification|CEP granted|04/10/2022;
Notification|CEP granted|26/07/2022;
Minor revision|CEP granted|13/09/2021
1589 Doxylamine hydrogen succinate HY-GRO CHEMICALS PHARMTEK PRIVATE LIMITED Secunderabad IN 100024077;100041595 CEP 2024-195 - Rev 00 2025/11/24 Valid 24/11/2030 Chemical 2025/11/24 New application|CEP granted|24/11/2025
2773 Memantine hydrochloride, Crystalline Form-I, Micronised and Non-micronised MSN PHARMACHEM PRIVATE LIMITED Sangareddy District IN 100014794;100023345 CEP 2025-237 - Rev 00 2025/11/24 Valid 24/11/2030 Chemical 2025/11/24 New application|CEP granted|24/11/2025

数据库说明:

当前数据更新日期:2026年04月05日。
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