Clinical approval of clopidogrel bisulfate tablets

Source: Yaodu headlines on November 5, 2016, Zhejiang Kangenbei Pharmaceutical Co., Ltd officially announced that Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd., the holding subsidiary of the company, has received the approval for clinical trial of clopidogrel bisulfate tablets approved and issued by the State Food and drug administration Clopidogrel bisulfate is a platelet inhibitor, which can inhibit platelet activation and aggregation through irreversible binding of its active metabolite with P2Y12 receptor of adenosine diphosphate (ADP) on platelets It is mainly used to prevent atherothrombosis and acute coronary syndrome Appendix: main contents of clinical trial approval document 1 Drug name: clopidogrel bisulfate tablet 2 Approval number: 2016l09139 3 Dosage form: tablet 4 Specification: 75mg (calculated by clopidogrel) 5 Application items: domestic drug registration 6 Registration classification: original chemical category 6 7 Applicant: Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd 8 Approval conclusion: after examination, the product meets the requirements of drug registration, and it is agreed to conduct human bioequivalence (be) test Clopidogrel bisulfate tablet is a product jointly developed by Jinhua Kangenbei and Zhejiang Kangenbei pharmaceutical research and Development Co., Ltd It submitted the application for registration of the product in March 2015 and obtained the approval for clinical trial of drugs approved and issued by the State Food and Drug Administration in October 2016 Up to now, Jinhua Kangenbei has invested about 1 million yuan in research and development of the product As of November 1, 2016, a total of 3 enterprises (Sanofi (Hangzhou) pharmaceutical, Shenzhen xinlitai pharmaceutical, Lepu pharmaceutical) have obtained production approval, and 2 enterprises (Sanofi CLIR SNC, Actavis group PTC EHF) have obtained import approval There are 51 Enterprises (including Jinhua Kangenbei) applying for copying and obtaining clinical trial (be) approval documents, and 9 enterprises applying for import clinical trial approval documents In addition, 24 enterprises are applying for the imitation or import of clopidogrel bisulfate tablets.