依索肝素钠流程优化研究

上海交通大学硕士学位论文依索肝素钠流程优化研究姓名：李西梁申请学位级别：硕士专业：工商管理指导教师：任建标20050610MBA-I-(EnoxaparinSodium)(Aventis)Sanofi-Synthelab200419.04-30%,MBA-II-STUDYONENOXAPARINPROCESSOPTIMIZINGABSTRACTEnoxaparinisoneoftheAventisPharmastrategicbrands.AfterSanofi-SynthelabgroupbroughtoverAventis,Enoxaparinbecomemoreimportant.In2004,netsalesofLovenox(Enoxaparin)wereup22.4%at1,904millioneuros.Theproductisbenefitingfromtheongoingconversionfromnon-fractionedheparinstolowmolecularweightheparins.Sanofi-Aventisheadquarterannouncedtoincrease30%oftheoutputoftheEnoxaparin,Duetothestronglyincreasingdemandsfromthecustomers.AventisPharmaPteLtdstronglyrequireshavingtherevolutionandbeginningthebusinessprocessoptimizing.ThisarticleanalysesthebusinessprocessoptimizingofAventisPharma(Singapore)especiallyontheproductionprocess,qualityprocessandsupplychainmanagement.Lowerbusinesscostsandincreasetheefficiencybecomesthecoremissionofmostcorporations.Becauseofshortageofrawmaterial,heparin,AventisPharmanowfocusonChinaheparinsources.ThisisaverygoodopportunityforChinabio-pharmaceuticalscompanies.Meanwhile,thisarticlealsoanalysestheneedsforChinabio-pharmaceuticalscompaniestogrowup.KEYWORDS:enoxaparin,patent,competitiveadvantage,businessprocessoptimizing,supplychainmanagement12005510220055102005523MBA-1-.-Sanofi-AventisSanofi-Synthelab2004820--200412696.15%499.9($602.43)68.1119.180.833SS1.161(54.05)64.27/Sanofi-Aventis---250AventisPharma199912(Hoechst)(Rhone-Poulenc)—(Strasbourg)91505Petroleum13.5%AventisPharmaFrandfurtAventisPharmaAGAventisPasteurAventisBehringDadeBehringAVEStoxx50MSCIFTS&PCAC42.2%40.1%AllegraLovenoxTaxotereDelixLantusActonelMBA-2-20032003178.152002206.2220022002200319.01200220.91EnoxaparinSodium,Lovenox/Clexane200321.3%,20.7%Lovenox200315%-199812SanofiSynthelabo214Total24%33.74%Opeal19.5%26.87%2004290004/152003200380.520.81426%56.5%Plavixavapra/aprovelStilnox/ambien——2004129“—()”20051——4———“”12001.7—“”MBA-3-I~IIIEnoxaparin,Clexan/Lovenox••••Q•••••••/•5220mg/0.2ml,40mg.0.4ml,60mg/0.6ml,80mg/0.8ml,100mg/1.0ml,AventisPharmaMBA-4--530kDa,15kDa,30,(1995),1mg150(Mucosa),(Mucosa)200020003800/×1001×/20021020%6(39%)20%7%200110%15%-MBA-5--Enoxaparin1987,1993()96,1.08Lovenox()Clexane()(Rhone-Poulenc)19997520001042200419.04,200322.4%20041220042003224%-200371%2-12-12004-2004()2003()2003()2003Lovenox19.0415.5616.47+22.4%Plavix16.9413.1413.25+28.9%Allegra15.0216.1417.40-6.9%Taxotere14.3612.9013.59+11.3%Stilnox/Ambient14.2312.3413.45+15.3%LovenoxEnoxaparinAllegraTaxotere61%48.422-1MBA-6-Lovenox24%Plavix21%Allegra19%Taxotere18%Stilnox/Ambient18%2-11998-2002380%2-22-220036AmphastarTevaFDALovenox/clexane(EnoxaparinSodium)46924354(200412)LovenoxTeva2004127200419.04200316.47200212.64200110.5120008.4419996.1719984.29MBA-7-AmphastarANDA45389618(2012214)200485,389,61820052003theFederalTradeCommission1984Hatch-Waxman30200310304202005972005111530TevaAmphastarLovenox1Sanofi-SynthelaboFraxiparine/ArixtraOrganonXa200112FDA20022320029101231145MBA-8-1232002327fondaparinux(Arietta)12.5mgArixtraEnoxaparin54%ArixtraXa-2PfizerFragmin(DalteparnSodium)19952001602.261996FDAQ3AstraZenecaExanta(ximelagatran)200415514100WHO60WarfarinWarfarinCoumadin50(FDA)MBA-9-EXPRESS,(VTE)——FDA50Fragmin(ICT)Exanta(ximelagatran/mel-agatran)()()()1.Q19931200113002345aspirinQ2006warfarin72-2MBA-10-219933.19871AventisEnoxaparinsodium,Lovenox/Clexane8545389618(2012214)5200492325-VillaVigoni(Loveno,LakeComo)-6200402004006008001,0001,2001,4001,6001,8002,000200520062007200820092010201120122013SurgeryMedicalDVT/PECardioOthers2-22005-2013MBA-11-Dehecq201610%200460%200520061.2.3.12244.2080905.MBA-12-2000120820037002546.7,,,MBA-13-123MBA-14-1992MRPSAP/R33-13-1MBA-15-3-2©3-2MBA-16-19997582530%334-14-1SCG-MBA-17-4-24-24-3BenzethoniumchlorideDPWaterR211001700lSSDPWaterR212003000lSSBenzethoniumheparinateHeparinsodiumBigbagDelumperDPWaterCF214002.26sqmSSD21600D21700D218003∗18sqmSSMBA-18-4-34-44-44-5BenzylchlorideDCMR222001500lGLMethanolR223001900lSSCF224002.26sqmSSHeparinbenzylestercrudeSodiumacetateBigbagDelumperD22600D227002∗14sqmGLDPWaterBenzethoniumheparinateMethanolHeparinbenzylestercrudeR23100900lSSMethanolR232001400lSSCF234001.16sqmSSHeparinbenzylesterpureDPwaterD23600D237002∗12sqmSSSodiumchlorideDPWaterMethanolMBA-19-4-54-64-6R241001700lSSCF244001.16sqmSSSodiumhydroxideSodiumchlorideMethanolMethanolHydrochloricacidDPwaterEnoxaparincrudeD24600D247002∗14sqmSSR25100500lSSF25180EnoxaparincrudeSodiumhydroxideHydrogenperoxideSodiumchlorideHydrochloricacidDPwaterDPwaterR25300500lSSF253800.2µmMethanolR25400R254502∗800lSSF255000.69sqmV25630SSDPwaterC256000.6∗2.0mSSCartridgeFilter0.2µmEnoxaparinpureMixingDPwaterV25730SSMBA-20-838244-14-11.03.07221622266611111133333321216363212121216363181818185454181818185454545414.514.514.514.543.543.543.543.5282884842727`818120037004259199920054-7MBA-21-5588825250.2135456.2505101520253019992000200120022003200420054-7200513.4-24-213446/19/260448/25/2525/19/8/34480.851.22X62X1825/8/3448MBA-22-2.4-34-32005123455c5d5h2005-25/540003211181362005-25/54121221111014488200533.S5P-GUEDUS5C-S5D-S