~CеƼϺ˾ܛܶƌI(y)ԭh(hun)ɳm(x)ϾGɫˎ P(gun)עa(chn)Ʒȫ҂]h(hun)ܛܿɻLO(sh)ӋpُUa(chn)a(chn)^ѭh(hun)˜xõĿoܛpٸQlnjYԴĹ(ji)sI(y)̼E`оGɫɳm(x)ˎ؟(z)ԭˎY(ji)ĸҺݔ** Y(ji)ĸҺߝ܄}ּAPIgԏҾoL(fng)U**ʳƷoܛ܄Û״ҴIPA}Y(ji)g(do)oO(sh)Ӌ_늌(do)ĸҺȫݔ͉O(sh)Ӌm(yng)xęCжωϽY(ji)형ЧTOC⻬(ni)ڣKzEPDMʳƷoܛϺW(xu)܄oz~F(xin)؛
Ϻ~a(chn)UPEW(xu)mbO(sh)ʩڻW(xu)I(y)mųs95%лW(xu)|(zh)ߝA܄ȺVԼ紼ЙCͪͷ̼仯rҺʯͨûW(xu)ܛܼg(sh)(sh)ܛܽY(ji)(gu)ܛܣUPEɫ⻬FDAܛwSŤ䓽zܛӣEPDMɫψDͳӰ裺R109ضȷ-40C100Cע@ǿܵ坍ܛܮ(dng)pߜضȞ130Cs30ÿLȣ40ϺozNԭˎI(y)CMO/CDMOˎ˾I(y)O(sh)ُa(chn)аl(f)Tؓ؟(z)
ڇܿصˎ﹤̝h(hun)~CеƼϺ˾Č(do)oPTFEzܰҪw̎ɫ䑪(yng)؞ԭˎϳgwD(zhun)ƵKƄҺbȫݔȵᣨᣩA簱ˮЙC܄Ҵ܄DMSOԼ_}ҺB(yng)wPTFEĿɿW(xu)Դ_|(zh)ܹ·ܳȾMUSP Class VIFDA 21 CFR 177.1550Ҫ(do)oڴʹЙC܄a(chn)^(q)ȡϳ܇gȞҪֹo늸ɔ_܃xl(f)(zi)⻬oǵă(ni)O(sh)ӋҲھϴCIPھSIPGMPoa(chn)Ҏ(gu)
~CеƼϺ˾l(wi)goķܛ܌GMPҎ(gu)ԟo Ϻ~ܛܿԝMԭˎa(chn)cҎ(gu)Ҫijɶ҂Ϻ~ܛܲ100%ʳƷ䷽oܻwƣDEHPoouMUSP Class VIFDAEC1935/2004EU 10/2011ȇJC⻬op(ni)ڶŽ^cϴoܳ־÷(wn)_a(chn)ȫ̷GMPҎ(gu)ṩ|(zh)cJCļpͨ^ӋṩATEXָ2014/34/EUJC(do)oܛܣ<10we<10
Ϻ~ṩUPEzһNʹó߷ϩUPEƳɵĹܵUPEһNԹгɫĥ͛_ͻW(xu)gԺ͵ĦԵcˣUPEzڶI(lng)жЏVđ(yng)UPEzܵһЩҪc͑(yng)I(lng)ĥԣUPEzܵă(ni)ڹ⻬UPEϱЃ(yu)ĥԣʹzݔϕr^͵ĥpLʹÉͻW(xu)gԣUPEό(sh)W(xu)ƷгɫgԣA}@ʹUPEzm̎NgԽ|(zh)͛_ԣUPEzܾ^ߵĿ_ȣ܉ֿⲿ_Cܵϵy(tng)ķ(wn)\СĦԣUPEϵĦϵ(sh)^ʹUPEzݔϕr^͵ܺĺĦpʧcUPEzI(lng)еõV(yng)ãVɽú̿ИI(y)ݔú{{ԼĥܵrұИI(y)ݔͻVȹwUԼĥܵݔ͎W(xu)I(y)ݔNgԽ|(zh)ᡢA}ȡʳƷI(y)ݔʳƷԭϵȡ(wn)ɿĹ(yng)a(chn)Bm(x)g(yng)ͻl(f)ϺPFAozܻW(xu)ԭˎ
pٮa(chn)Ʒʣ FԭˎgwճܱǾMϺW(xu)܄oz~F(xin)؛
~CеƼϺ˾gozǕrot(y)ˎa(chn)ȫ t(y)ˎgwԭˎԭˎϳݔȼױ܄rͨܛeo˲gl(f)(zi)y҂ʳƷozܛ(ni)ǶЧ(do)늌ӣ_o늼r(do)(do)oϵ(sh)10صŽ^ȼL(fng)UwǰEPDMzܴͪȶNЙC܄g FDA 21 CFR 177.2600˜APIa(chn)ǰéɿİȫÿһ܄ȫD(zhun) ϺW(xu)܄oz~F(xin)؛
~CеƼϺ˾2014עṩɿI(y)ܛܼwݔͽQ˾Mڼg(sh)cаl(f)IKzgozܡʳƷطܛܵȮa(chn)Ʒwt(y)ˎʳƷԴI(lng)ĝwݔ˾Ҫa(chn)Ʒط(ni)ԪұzEPDMӵM|(zh)͏ᏊAo늣裼10ߵ͜أ-40~200棩R漉⻬(ni)@ϴЧʲŽ^ȼL(fng)U78ܛܾͨ^FDAUSP Class VIEN12115JCMˎcʳƷИI(y)ćҎ(gu)Ҫ