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某公司兽药GMP车间建设项目

4239
21
2019-03-23
简介
本项目建设年产100吨伊维菌素原料药及其衍生产品。

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2013年省级工业企业技术改造专项资金申请报告项目名称:兽药GMP车间建设项目申报单位:XXXXX所属县市:XXXXX联系人:XXXXX电话:XXXXX申报时间:XXXXX产品结构优化专项生物制药I目录第一章项目概况·······································································11.1项目名称··········································································11.2项目建设地点····································································11.3项目承建单位基本情况·······················································11.4项目内容概要····································································11.5环境保护··········································································51.6总投资及资金来源·····························································61.7项目效益情况····································································61.8项目审批及进展情况··························································61.9项目主要技术经济指标一览表··············································7第二章项目建设背景及必要性····················································122.1国家政策········································································122.2项目产品的国内外市场情况················································132.3企业发展的内在需求·························································16第三章申请专项资金的理由和政策依据········································183.1申请专项资金的理由·························································183.2政策支持········································································18第四章项目建设规模及工艺技术方案···········································214.1建设规模及产品方案·························································214.2工艺技术方案··································································22II4.3主要设备方案··································································314.4原料及辅助原材料····························································39第五章工程技术方案································································415.1自然条件········································································415.2总图运输········································································435.3土建工程········································································455.4公用工程········································································45第六章节能分析······································································516.1节能依据········································································516.2项目节能背景分析····························································536.3项目能源耗能种类及数量···················································546.4节能措施········································································556.5能源管理········································································606.6项目能耗指标及分析·························································61第七章环境保护······································································627.1环境执行标准··································································627.2环境影响分析··································································627.3环境保护措施··································································647.4环境影响评价结论····························································67第八章项目实施进度································································688.1编制依据和原则·······························································68III8.2项目实施进度计划安排······················································68第九章项目招标方案································································709.1招标依据········································································709.2招标范围········································································709.3招标组织形式··································································709.4招标方式········································································70第十章投资估算与资金筹措·······················································7210.1概述·············································································7210.2投资估算·······································································7210.3资金来源与筹措·····························································74第十一章财务评价···································································7511.1基础数据·······································································7511.2财务评价·······································································7611.3风险分析·······································································7711.4效益评价·······································································7911.5结论·············································································81附表1、总投资估算表2、营业收入、营业税金及附加和增值税估算表3、固定资产投资估算表4、流动资金估算表5、总成本费用估算表6、项目投资现金流量表7、项目资本金现金流量表8、财务计划现金流量表9、资产负债表10、利润及利润分配表11、借款还本付息计划表12、经济评价指标汇总表附图1、项目所在园区中地理位置图2、项目总平面布置图附件1、企业营业执照、组织机构代码证、税务登记证银行信用等级证、产品生产许可证2、项目备案的批准文件3、土地协议和规划许可文件4、环境影响评价审批意见5、项目开工证明6、节能审查意见7、贷款合同、借款借据和企业贷款卡8、自有资金证明文件9、项目建设进度相关资料10、企业未拖欠各项保险费证明11、企业未拖欠各项税费证明12、企业不拖欠职工工资证明13、财务审计报告14、申报材料真实合法的保证书兽药GMP车间建设项目资金申请报告1第一章项目概况1.1项目名称兽药GMP车间建设项目。1.2项目建设地点本项目建厂址位于1.3项目承建单位基本情况1.4项目内容概要1.4.1建设规模与产品方案1、建设规模本项目占地3.33公顷,建筑面积25432平方米,建设年产100吨伊维菌素原料药及其衍生产品。建设GMP车间和制剂车间,公司与中国农业科学院兰州畜牧与兽药研究所共同研发生产技术并获得技术专利,购置国内领先的合成反应设备,全部国内生产。新增建筑包括:伊维菌素原料药车间、液体制剂车间(包括最终灭菌大容量非静脉注射液/非最终灭菌大容量非静脉注射液生产线和口服液生产线)、固体制剂车间(包括粉剂生产线、预混剂生产线、片剂/颗粒剂生产线)、添加剂预混合饲料车间、消毒剂(液体)/杀虫剂(液体)车间、仓库、质检楼以及各生产车间配套工程。2、产品方案产品方案详见下表:兽药GMP车间建设项目资金申请报告2表1.4-1产品方案序号产品名称产量/年备注1伊维菌素原料药100吨2注射剂600万瓶50mL/瓶3口服液200万瓶100mL/瓶4可溶性粉剂180万袋100g/袋5预混剂100吨6消毒剂/杀虫剂10万升7片剂2000万片4g/片8颗粒剂20吨9添加剂预混合饲料500吨在产品质量方面,企业生产的产品符合中华人民共和农业部《兽药质量标准》(CPV2003/USP31)中关于兽药各项指标的要求。1.4.2厂址情况该项目占地3.33公顷,项目所在厂区外围生态环境好,与居民集居地间隔一段距离,烟尘、噪音等污染几近于零。项目所在厂区周边环境优美无任何污染,地势平坦,水源充沛,厂区内水、电、汽等公用设施齐全。项目总投资13098.8万元,投资强度为261.98万元/亩。1.4.3生产工艺与主要设备1、工艺技术及产品特点本项目的技术为公司与中国农业科学院兰州畜牧与兽药研究所共同研发生产技术并获得技术专利,公司长期与中国农业科学院兰州畜牧与兽药研究所农业部创新兽药重点开放实验室进行技术合作,进行新产品、新工艺的开发,技术达到国内领先水平。为农业部创新兽药重点开放实验室的兽药GMP车间建设项目资金申请报告3研究生实习基地。同时美荷药业与兰州市职业技术学院建立了学生订单班培育,为企业提供高质量技术工人。采用本项目生产技术后,缩短伊维菌素原料药生产时间,加氢催化时间由国内企业普遍生产所需的8个小时,缩短到2.5个小时,大大减低了生产所需时间,提高了生产效率,降低了能源消耗。同时,采用该技术,降低了反应所需的催化剂用量,生产100kg伊维菌素所需催化剂量由国内企业普遍生产所需的150g,降低到70~80g的水平,由于反应中催化剂的成本较高,从而降低了公司的生产成本。企业还将加氢催化反应釜压力由国内企业普遍生产所需的3.5MPa降低到2.0MPa,使产品结晶收率由全国同类生产厂家的88%提高到94%左右,提高了产品收率,降低了能源消耗,提高安全生产系数。2、设备概况本项目设备选择原则为:设备先进、成熟适用;生产稳定、安全可靠。为了确保产品质量,同时考虑到节省基建投资,本项目选择国内先进的伊维菌素生产氢化反应设备、提纯、干燥设备,建设万级洁净区;注射液生产设备;口服液生产设备;片剂/颗粒生产设备;添加剂预混合饲料生产设备;粉剂/预混剂生产设备;外用杀虫剂/消毒剂生产设备。公司已经建成了现代化的伊维菌素生产线,取得了国家的伊维菌素生产经营许可证,于2012年2月通过了国家兽药GMP认证,有完善的生产设施设备和检验设备。本项目所选设备处于国内先进水平,均无国家明令淘汰的设备。1.4.4原材料供应本项目所需主要原料由XXXXX供应,地理位置优势明显,运输交通兽药GMP车间建设项目资金申请报告4便利,供给货源有可靠、保障。其生产辅助材料、包装,主要由XXXXX等供应或者当地市场采购,因此,原料和辅助材料供应能满足本项目需求。1.4.5工程技术方案1、总平面布置简述总图布置力求工艺流程合理,运输畅通。建筑物要经济实用、简洁美观,既满足工艺的功能要求,又要充分体现出现代化工厂的风格。本项目总图布置分办公生活区和生产区两大区域。生活区有南向北,依次布置研发试验楼和办公楼;生产区有西向东依次布置成品库、原料库、生产车间、配电室、烘干包装车间等。环厂区有宽12米的厂内路,使工厂的运输路线短捷,在物料以及能源的输送过程中减少损失,降低消耗,有利于提高生产效率和降低运输成本。2、建构筑物概况本项目总建筑面积为25432平方米,建(构)筑物详见表1.4.2。表1.4.2主要建(构)筑物表序号工程名称数量建筑面积(m2)结构形式备注1原药生产车间13600框架结构2原药生产车间13000框架结构3液体制剂车间12700框架结构4固体制剂车间13600框架结构5混料车间1972框架结构6杀虫剂、消毒剂车间11440框架结构7原辅包材库11200轻钢单层排架结构8成品库11200轻钢单层排架结构9生产车间154框架结构兽药GMP车间建设项目资金申请报告5序号工程名称数量建筑面积(m2)结构形式备注1原药生产车间13600框架结构2原药生产车间13000框架结构3液体制剂车间12700框架结构10液体制剂车间1576框架结构11棚库11010框架结构12仓库11100轻钢单层排架结构13棚库1102轻钢单层排架结构14综合楼14590框架结构15研发楼1288框架结构16配电室12700砌体结构总计254323、能源需用量及供应情况本项目所需能源种类分别为蒸汽和电力,耗能工质为水和压缩空气。年需电力194.04×104kWh,供电电源采用双电源供电,一路引自XXXXX热电厂,一路由35kv变电站供应;年需用蒸汽量为7920t,工业园区集中提供热源;年需新水4.95×104m3,利用厂区现有两眼自备水井,井深200m,每眼出水量35~40t/h;年需压缩空气量为190.08×104m3,由厂区空压站提供。4、辅助设施情况项目配套购置空压机组、污水处理、制水系统等辅助设施,并新建空调、制冷工程等设施。项目辅助设施可保障正常生产。1.5环境保护本项目运营过程中产生的主要污染物包括:生产废水、生活污水,固体废弃物、废气、厂界噪声等污染。本项目生产废水排入厂区下水管网,与经化粪池处理后的生活污水一兽药GMP车间建设项目资金申请报告6同集中排入XXXXX污水处理站。项目可溶性粉剂、预混剂车间产生的无毒粉尘经除尘机组,进行除尘处理后排入大气;阿维菌素生产车间废气,由活性炭吸附。项目产生的塑料、纸盒等包装废料,作为再生材料回收,并于翔宇环保公司签订废弃物处理协议。设备选用低噪声设备,针对所有较大的噪声源采取隔声、消声、减振等降噪措施。项目污染物经采取措施后,均能达标排放,对周围环境影响较小,项目具有良好的环境效益和社会效益。1.6总投资及资金来源本项目总投资为13098.8万元,其中固定资产投资为9895万元,铺底流动资金为3204万元。总投资13098.8万元已向银行申请贷款2100万元,其余10998.8万元由企业自筹资金解决。1.7项目效益情况本项目达产后年均销售收入为32000万元,年利润总额为5337.4万元,税后财务内部收益率24.83%,税后投资回收期6.59年,盈亏平衡点为30.86%。盈余公积金按税后利润的10%提取。息税前利润为5356.3万元,净利润为4003.05万元。总投资收益率为26.03%,资本金净利润率为51.35%。1.8项目审批及进展情况1、备案情况XXXXX2、土地情况兽药GMP车间建设项目资金申请报告7XXXXX3、环评情况XXXXX4、城市规划情况XXXXX5、节能评估情况XXXXX6、资金投入情况:土建费用1500万元,设备费用3300万元,共计4800万元,项目形象进度为36%。1.9项目主要技术经济指标一览表表1.4-3主要技术指标一览表序号项目名称单位数量备注1生产规模及产品方案1.1伊维菌素原料药t/a1001.2注射剂万瓶/a60050ml/瓶1.3口服液万瓶/a200100ml/瓶1.4可溶性粉剂万袋/a180100g/袋1.5预混剂t/a1001.6消毒剂/杀虫剂万升/a101.7片剂万片/a20004g/片1.8颗粒剂t/a201.9添加剂预混合饲料t/a5002年操作日天3303日工作时间小时244主要原辅材料用量兽药GMP车间建设项目资金申请报告84.1阿维菌素t/a1204.2乙醇t/a3004.3甲苯t/a2104.4土霉素t/a304.5硫酸新霉素t/a104.6伊维菌素t/a104.7丙二酮t/a5004.8无水葡萄糖t/a2004.9包装箱万只/a504.10西林瓶万支/a9004.11玻璃瓶万个/a3004.12铝塑复合袋m2/a3000005公用动力消耗量5.1水t/a4.95×1045.2电kWh/a194.04×1045.3蒸汽t/a79206全厂定员人1206.1其中:生产工人人806.2技术人员人256.3管理人员人157总占地面积m233333.33(3.33公顷)8全厂建筑面积m2254329全厂综合能耗总量tce/a951.2810单位产值能耗tce/万元0.029711单位工业增加值能耗tce/万元0.2912项目总投资万元13098.812.1建设投资万元970612.2建设期利息万元18912.3铺底流动资金万元3204兽药GMP车间建设项目资金申请报告913营业收入万元3200014增值税万元1406.1115营业税金及附加万元140.616总成本费用万元26224.7717年均利润总额万元5337.418年均所得税万元1334.3519年均税后利润万元4003.0520项目投资所得税前指标20.1投资回收期年5.7320.3项目投资税前财务内部收益率%32.8120.3项目投资税前财务净现值(Ic=12%)万元8567.7821项目投资所得税后指标21.1投资回收期年6.5921.2项目投资税后财务内部收益率%24.8321.3项目投资税后财务净现值(Ic=12%)万元2506.1522资本金财务内部收益率%24.6823资本金净利润率%51.3524总投资收益率%26.0325盈亏平衡点%30.86第8年兽药GMP车间建设项目资金申请报告12第二章项目建设背景及必要性2.1国家政策我国高度重视兽药及兽用保健品行业的健康发展,2007年4月,国务院办公厅出台了《生物产业发展“十一五”规划》,在其主要任务和发展重点中,提出“开发并推广应用生物农药、生物肥料、植物生长调节剂、生物饲料添加剂等重要农用生物制品15个左右,开发并推广应用畜禽新型疫苗等动物用生物制品和制剂40~50种。”2007年6月,农业部制定了《农业科技发展规划(2006~2020)》,《规划》提出“研究开发新型疫苗、新型化学合成药、中兽药和诊断试剂,建立兽药安全评价体系”国家鼓励在兽药行业的瓶颈性与紧迫性的科技领域超前部署,开展自主创新,形成自主知识产权成果。”2008年12月31日,农业部公布的一、二、三类动物疫病名录共有147中,其中一类病17个,需要施行强制免疫措施,目前有高致病性禽流感、口蹄疫、高致病性猪蓝耳病、猪瘟等少数疫病实行了强制免疫措施。2012年12月29日,国务院关于印发《生物产业发展“十二五”规划》的通知(国发〔2012〕65号),“专栏六”农用生物制品发展行动计划的主要内容包括:支撑体系建设,构建生物兽药、生物农药、生物饲料、生物肥料等重要农用生物制品资源信息库、产品研发共享平台和产品孵化基地,完善国家农用生物制品产业支撑体系。《兽药管理条例》和《兽药注册办法》突出了鼓励创新、加强新药保护、保证兽药安全、有效和质量可控的立法精神,国家实行兽用处方药和非处方药分类管理制度;国家实行兽药储备制度;国家鼓励研制新兽药,兽药GMP车间建设项目资金申请报告13依法保护研制者的合法权益;新兽药的保护期限延长到6年。在新药保护期内只允许取得新药证书的企业生产销售新药,其它企业不得仿制,以保护新药研制生产企业不致遭受激烈的价格竞争,以使新兽药生产企业获得更好的利润。农业部的442号公告发布了中兽药、天然药物分类及注册资料要求、化学药品注册分类及注册资料要求、兽用消毒剂分类及注册资料要求、兽药变更注册事项及申报资料要求,明确了新兽药研究和申报的具体技术要求,在与国际接轨的同时更能指导我国的新兽药的研究与开发。2.2项目产品的国内外市场情况2.2.1国外市场情况全球兽药市场中生物制品的销售比重较高,随着集约化养殖的发展,以及动物疫病不断变化的情况,生物制品的增长迅速,将是今后兽药市场中发展前景最好的类别。这主要归功于以下几点:继续倾向于预防而非治疗的政策趋势;欧洲、拉丁美洲致力于口蹄疫和蓝舌病疫苗免疫的策略;不断变化的疾病压力推动新抗原和多价苗的研发;新的生物技术产品的出现。预期主要的增长潜力将来自于大型食用动物生物制品和水产用疫苗方面的持续增长。图2.2-1按产品种类分兽药全球销售状况兽药GMP车间建设项目资金申请报告14图2.2-2全球产品结构比较(按产品类别)目前国际兽药产业己经进入垄断发展时期,跨国企业兼并重组,强强联合,注重产品研发和品牌,国际巨头的垄断地位己经形成。国际市场中药品的概念包括人药、兽药和农药,很多制药企业都有兽药子公司或兽药部门,因此在全球制药企业刮起兼并收购的浪潮中,兽药产业,也不例外地加入了其中。如辉瑞公司、先灵葆雅、梅利亚都是经历多次收购和兼并才稳居全球兽药行业前列。目前,全球兽药销售集中度进一步提高,前五大制药企业的销售额占全球兽药总销售额的2/3左右。2.2.2国内市场情况目前,我国已成为继美国之后的第二大动物保健品消费国。预计未来几年随着我国畜牧业的发展,兽药行业仍将保持平稳增长态势,较欧美等发达国家市场而言,国内兽药行业起步较晚,在整体行业技术水平和市场规模上仍与国外有较大差距。但随着国家对动物疫情防控和食品安全的逐步重视,国内兽药行业发展迅速,近几年一直保持高速增长态势。2005~2010年,国内兽用药品行业市场规模由138亿元增长到304亿元,复合增长率达17.11%。目前我国已形成比较完整和成熟的产品结构。国内的兽药市场以兽用兽药GMP车间建设项目资金申请报告15药物制剂为主,根据中国兽药协会的统计,2011年国内兽药总消费额334.72亿元中,兽用药物制剂的总消费额为261.39亿元,占兽药市场容量的78.09%;兽用生物制品的总消费额为73.33亿元,占兽药市场容量的…
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