XLS《Sheet3》

"附件1" "双信封招标经济技术标评审结果勘误列表" "招标单元序号","原竞价分组","产品编号","药品通用名","细化剂型","规格/用法用量","生产企业名称","原审定结果","现审定结果","修改原因" "1833","第二竞价组","GX0002_13_3","铝碳酸镁片","片剂","0.

5g","广西南宁百会药业集团有限公司","药品质量认定为"首仿(创)药品"","药品质量修改为"其他GMP药品、其他进口药品",竞价分组修改为"第三竞价组"","复查原申诉资料,企业未在规定时间递交省级食药部门关于首仿(创)药品证明材料,申诉为首仿(创)药品的事项不予认可,同时清理核查该品种下所有产品的首仿(创)药品资料,重新予以判定" "1833","第三竞价组","CQ0019_3_3","铝碳酸镁片","片剂","0.5g","重庆华森制药股份有限公司","药品质量认定为"其他GMP药品、其他进口药品"","药品质量修改为"首仿(首创)",竞价分组修改为"第二竞价组"","广西南宁百会药业集团有限公司投标的铝碳酸镁片的首仿(创)药品不予认可,重新认定铝碳酸镁的首仿(创)药品,该产品递交的证明材料符合方案认定要求" "1685","第三竞价组","JX0039_2_1","活血止痛片","薄膜衣片","每片重0.6g","江西山香药业有限公司","行业排名认定为"0"","行业排名修改为"第10名"","复查原企业申诉资料,企业确已在规定时间内递交行业排名资料,其行业排名为中成药类第10名" "1719","第三竞价组","JL0149_1_1","苦碟子注射液","注射液","每支装10ml","通化华夏药业有限责任公司","产品产量排名认定为"第2名"","产品产量排名修改为"第1名"","复查原申诉资料,企业确已在规定时间内递交产品产量排名资料,产品产量排名为第1名" "1793","第三竞价组","CQ0016_52_1","注射用头孢哌酮钠他唑巴坦钠","溶媒结晶粉针","2.0g","福安药业集团庆余堂制药有限公司","药品质量认定为"其他GMP药品、其他进口药品"","药品质量修改为"其他专利药品",竞价分组修改为"第二竞价组"","复查原审核资料,该产品符合药物组合物专利认定原则" "1798","第三竞价组","CQ0016_51_1","注射用头孢哌酮钠他唑巴坦钠","溶媒结晶粉针","1.0g","福安药业集团庆余堂制药有限公司","药品质量认定为"其他GMP药品、其他进口药品"","将药品质量修改为"其他专利药品",竞价分组修改为"第二竞价组"","复查原审核资料,该产品符合药物组合物专利认定原则" "95","第三竞价组","JL0143_2_1","30/70混合重组人胰岛素注射液","注射液","10ml:400IU","通化东宝药业股份有限公司","产品产量认定为"7名及以后"","产品产量排名修改为"第1名"","复查原申诉资料,企业确已在规定时间内递交产品产量排名资料,其产品产量排名为第1名" "117","第三竞价组","JL0143_4_1","精蛋白重组人胰岛素注射液","注射液","3ml:300单位(10.4mg)","通化东宝药业股份有限公司","市场占有率排名认定为"6名及以后"","市场占有率排名修改为"第1名"","重新核复查2014年产品覆盖率,应为第1名" "1381","第三竞价组","SC0004_202_1","注射用头孢唑林钠","普通粉针","0.5g(按C14H14N8O4S3计)","成都倍特药业有限公司","细化剂型认定为"普通粉针"","细化剂型修改为"溶媒粉针",同时将招标单元改为1379","复查原申诉资料,企业确已在规定时间内递交剂型为溶媒粉针的相关证明,应相应修改并重新划分招标单元" "1759","第三竞价组","SH0002_23_1","注射用泮托拉唑钠","冻干粉针","40mg","上海上药新亚药业有限公司","批准文号过期","批准文号截止有效期修改为"2021-05-15"","复查原审核资料中已递交了最新药品再注册批件,批准文号有效期至2021-05-15" "166","第二竞价组","HBE0076_1_1","注射用氢化可的松琥珀酸钠","冻干粉针","50mg(按氢化可的松计算)","福安药业集团湖北人民制药有限公司","药品质量认定为"首仿(首创)"","药品质量修改为"其他GMP药品、其他进口药品",竞价分组修改为"第三竞价组"","复查原审核资料中未递交任何首仿(首创)证明" "934","第三竞价组","JS0010_8_1","克拉霉素缓释片","缓释片","0.5g","江苏恒瑞医药股份有限公司","药品质量认定为"其他GMP药品、其他进口药品"","药品质量修改为"首仿(首创)",竞价分组修改为"第二竞价组"","复查审核时误将该产品纳入克林霉素组进行比较而未予认可,其产品原证明材料符合首访认定原则" "1112","第二竞价组","HBJ0005_65_1","注射用头孢呋辛钠","普通粉针","按C16H16N4O8S计:1.5g","石药集团中诺药业(石家庄)有限公司","药品质量认定为"获得省政府质量奖的药品"","药品质量修改为"其他GMP药品、其他进口药品",竞价分组修改为"第三竞价组"","复查原投诉资料,投诉方提交的专利查询显示该专利(CN201010290808)专利权终止,不符合方案要求" "1404","第二竞价组","SC0025_24_1","炎琥宁氯化钠注射液","注射液","100ml:炎琥宁80mg与氯化钠0.9g","四川奇力制药有限公司","药品质量认定为"首仿(首创)"","药品质量修改为"其他GMP药品、其他进口药品",竞价分组修改为"第三竞价组"","查该产品被投诉非首仿(创)药品,四川奇力应诉递交了放弃首仿(创)药品的材料,故不予认定为首仿(创)药品;