A randomized, open label, balanced, two-treatment, two-period, two-sequence, crossover, bioequivalence study of Single dose (0.6 mg) of Liraglutide 6 mg/ml solution for injection in pre-filled pen of Biocon Pharma Limited, India with Single dose (0.6 mg) of Victoza® (Liraglutide) 6 mg/ml solution for injection in pre-filled pen of Novo Nordisk A/S, Denmark, administered subcutaneously in healthy adult human subjects, under fasting condition - LIRA VICTOZA BE
A randomized open label two treatment two period two sequence crossover comparative bioavailability study of Single dose (0.6 mg) of Liraglutide 6 mg/ml solution for injection in pre-filled pen of Biocon Pharma Limited India with Single dose (0.6 mg) of Victoza�® (liraglutide) 6 mg/ml solution for injection in pre-filled pen of Novo Nordisk A/S Denmark administered subcutaneously in healthy adult human subjects under fasting condition - LIRAPK
A randomized, open label, balanced, two-treatment, two-period, two-sequence, crossover,bioequivalence study of Single dose (0.6 mg) of Liraglutide 6 mg/ml solution for injectionin pre-filled pen of Biocon Pharma Limited, India with Single dose (0.6 mg) of Saxenda®(Liraglutide) 6 mg/ml solution for injection in pre-filled pen of Novo Nordisk A/S,Denmark, administered subcutaneously in healthy adult human subjects, under fastingcondition
100 项与 Biocon Pharma Ltd. 相关的临床结果
0 项与 Biocon Pharma Ltd. 相关的专利(医药)
▲3月1-2日 MAH&DDS制剂合作大会 · 点击立即报名1月23日,人福医药集团股份公司发布公告,旗下子公司宜昌人福药业的麦考酚钠肠溶片获批上市,视同通过一致性评价,宜昌人福药业为该产品上市许可持有人。麦考酚钠是次黄嘌呤单磷酸脱氢酶(IMPDH)抑制剂,适用于与环孢素和皮质类固醇合用,用于对接受同种异体肾移植成年患者急性排斥反应的预防。麦考酚钠肠溶片由 Novartis 公司开发,最早于 2002 年10 月在瑞士批准上市,目前已在美国、中国、欧盟等多个国家和地区上市销售。麦考酚钠肠溶制剂开发,其处方工艺、BE、稳定性研究及溶出均有一定难度,国产药企中仅有成都盛迪医药与宜昌人福药业获批。欢迎加入群聊仅供交流2021年3月,恒瑞医药子公司成都盛迪医药的麦考酚钠肠溶片获批上市,视同通过一致性评价,为该品种国内首仿。据恒瑞医药公告披露,麦考酚钠肠溶片项目累计投入研发费用约为 2,796 万元。宜昌人福于2022年6月向国家药品监督管理局提交了麦考酚钠肠溶片的上市许可申请,于今年1月获批,截至目前累计研发投入约为1,700万元人民币。人福医药公告披露,2022年麦考酚钠肠溶片在我国城市、县级及乡镇三大终端公立医 院的销售额约为11.5亿元人民币。据药融云数据库显示,目前国内麦考酚钠肠溶片有在使用批文10个,涉及4家企业:原研企业诺华(Novartis)、印度药企Biocon Pharma Limited、成都盛迪医药以及宜昌人福药业。此外,山东新时代药业、重庆圣华曦药业、四川科伦药业等多家药企的麦考酚钠肠溶片也已报上市,目前正在审评审批中。
100 项与 Biocon Pharma Ltd. 相关的药物交易
100 项与 Biocon Pharma Ltd. 相关的转化医学