Ukungonelanga kwemathiriyeli ekrwada eJapan

I-Active Pharmaceutical Ingredients (APIs) idlala indima ephambili kwishishini loxubo mayeza kwaye sisiseko esisisiseko sokwenziwa kwawo onke amayeza.

Ubungakanani bemarike yeshishini lamayeza laseJapan likwindawo yesibini eAsia.Ngokunyuka kwenkcitho ye-R & D yoshishino lwamachiza kunye nezinye izizathu, kulindeleke ukuba i-market ye-APIs yaseJapan iya kukhula ngesantya esiphezulu se-7% ukuya kwi-8% ngo-2025. Phakathi kwabo, iinkampani zonyango eziye zadlala indima ebalulekileyo ziquka. I-Sun Pharmaceutical, i-Teva, i-Novartis International AG, i-Piramal Enterprises, kunye ne-Aurobindo.

Uphuhliso lweshishini lamachiza enziwe afana nalawo enziwe afana nalawo enziwe ngabenzi eJapan nalo lujongene nomqobo wokungonelanga kobonelelo oluzimeleyo lwemathiriyeli ekrwada.Phantse i-50% yee-APIs ezithunyelwa ngaphandle zisetyenziselwa ukuveliswa kwamachiza enziwe afana nalawo aveliswe ngabenzi, kwaye abona bathengisi bamazwe ngamazwe abaphambili basuka kumazwe ase-Asia naseYurophu afana ne-Indiya, i-China, i-South Korea, i-Itali, i-Spain, i-Hungary ne-Jamani.Ukuze kuncitshiswe ukuxhomekeka kwii-APIs ezithunyelwa ngaphandle, iJapan igxile kwi-APIs yendawo.

I-Sumitomo Pharmaceuticals, inkampani yokuqala eJapan ukuvelisa amachiza ekhemikhali kusetyenziswa itekhnoloji ye-organic synthesis ephuculweyo, iceba ukwakha i-APIs ye-molecule yeziyobisi kunye ne-intermediates factory e-Oita City, kwi-Oita Prefecture.Injongo ephambili yeprojekthi kukwandisa amandla okuvelisa i-API yenkampani ukuhlangabezana nemfuno ekhulayo yee-APIs ezikumgangatho ophezulu kunye nabaphakathi.

Isityalo esitsha sicwangciselwe ukusebenza ngoSeptemba 2024. Isebe lophuhliso lwekhontrakthi kunye nokuvelisa (CDMO) isebe lisebenzisa ubuchwepheshe obukhethekileyo ukuvelisa kunye nokubonelela ngee-APIs ze-molecule ezincinci kunye neziphakathi kwiinkampani zokuqulunqa, kunye nokuqonda intengiso yorhwebo yangaphandle.Ngenxa yemfuno emandla yeeprojekthi zophuhliso lwamachiza amatsha, imakethi yehlabathi yeCDMO yamayeza igcine ukukhula okuthe gqolo.Kuqikelelwa ukuba ixabiso langoku lentengiso yehlabathi jikelele yeyeza le-CDMO limalunga ne-81 yeebhiliyoni zeedola zaseMelika, elilingana ne-10 yezigidi zezigidi zeedola.

Ngokuthembela kwinkqubo yoqinisekiso lomgangatho ogqwesileyo kunye nezibonelelo zolawulo lonikezelo lwehlabathi jikelele, iSumitomo Pharmaceuticals ithe ngokuthe ngcembe yandise ishishini layo le-CDMO kule minyaka idlulileyo kwaye iseke indawo ephambili eJapan.Izityalo zayo eGifu naseOkayama zinamandla amancinci okuvelisa.Umthamo oqinileyo wokuvelisa ii-APIs kunye neziphakathi ezifunekayo kumachiza onyango lwe-molecular.Umenzi wekhontrakthi yamayeza eJapan iBushu Corporation ifikelele kwisivumelwano sentsebenziswano neSuzuken Pharmaceutical Company ngo-Epreli wama-2021 ukubonelela ngenkxaso yophuhliso lwemveliso entsha kwiinkampani ezichubekileyo zoxubo-mayeza ezijonge ukungena kwimarike yaseJapan.UBushu unethemba lokuqhuba isivumelwano sentsebenziswano kwimveliso yasekhaya ngokuthe ngqo yee-APIs, ngokusebenzisana kweenkampani ezimbini zoxubo-mayeza, ukubonelela ngeenkonzo zolawulo lwe-one-stop kwimfuno yamachiza akhethekileyo, kubandakanywa ukukhuthazwa kwabanini-zigunyaziso/abanini beziyobisi ukudlulisa ukubonisana, ukungenisa elizweni, ukuphononongwa kwemarike, iMveliso kunye nonikezelo, ukugcinwa okuphathisiweyo kunye nothutho, ukuvavanywa konyuselo kunye noncedo lwesigulane kunye nezinye iinkonzo.

Kwangaxeshanye, iBushu Pharmaceuticals inokuhambisa amayeza ngokukhuselekileyo kwizigulana kuyo yonke inkqubo ngokusebenzisa isixokelelwano esikhethekileyo sechiza esincinci esibanda kakhulu (Cubixx) esiphuhliswe yiSuzuken Co., Ltd. Ukongeza, iNkampani yaseJapan iAstellas Pharmaceutical Company idize ukuba ngoko isicwangciso sesithathu sokwandisa imveliso, isiseko se-API sokuveliswa kweziyobisi ezisisigxina ezisekwe eToyama, eJapan ngoJanuwari 2020 ziya kusetyenziselwa ukuvelisa i-Astellas Prograf's tacrolimus hydrate API.

I-Tacrolimus lichiza elithintela kwaye linyange ukwaliwa kwamalungu abantu abadala kunye nabantwana abafumana isibindi, izintso, intliziyo (kunye nemiphunga yemvume ye-FDA ngo-2021) ukutshintshwa.