Njengomsebenzi osebenzayo kwiziyobisi, i-API ibangela iziphumo zeziyobisi
Ukuveliswa kwama-API kuye kwenzelwa ngamaqumrhu okuxuba amayeza ngokwabo kumazwe abo asekhaya. Kodwa kwiminyaka yamva nje ezininzi iinkampani ziye zakhetha ukuthumela ukuveliswa kwezilwandle ngaphandle kokunciphisa iindleko.
Oku kubangele utshintsho olubalulekileyo kwiindlela ezi zilawulwa ngayo iziyobisi, kunye nezikhokelo ezingqongqo kunye nokuhlolwa okufakwe kuyo.
Iimpawu zoMilwa
Zonke iziyobisi zenziwe ngamacandelo amabini angundoqo: i-API, eyona isithako esisisiseko, kunye ne-excipients, izinto ezingaphandle kweziyobisi ezinceda ukuhambisa amayeza kwindlela yakho. Iimfuno zendalo ezingasebenzi, ezifana ne-lactose okanye i-oil oil.
Ngokomzekelo, ukuba unentloko, i-acetaminophen iyisithako esisebenzayo, ngelixa i-liquid in capelle ye-gel okanye ubuninzi bepilisi yi-excipient.
Amandla API
Abavelisi basebenzisa imigangatho ethile ukuqinisekisa ukuba i-API inamandla kangakanani kwisilwanyana ngasinye. Nangona kunjalo, umgangatho ungahluka ngokubanzi ukusuka kolunye uphawu ukuya kwelinye. Elunye uphawu lusetyenziswa uvavanyo olulodwa, enye enye eyahlukileyo. Kuzo zonke iimeko, abavelisi bafunwa yi-FDA ukubonisa ubungqina bemveliso yabo kwizigulane zangobomi, kunye neemeko zelabhoratri.
Abenzi be-API abaphezulu
Umenzi okhokelayo we-APIs yi- TEVA Pharmaceuticals . Ngeemveliso ezingaphezu kwe-300 ze-API, zineyona nto iphambili. Omnye umenzi okhokelayo nguDkt. Reddy's, onama-API angaphezulu kwama-60 asetyenziswa namhlanje.
Kuphi i-APIs eyenziwe?
Ngelixa iinkampani ezininzi zezobisi zifumaneka eUnited States naseNgilani, abaninzi abenzi be-API bangaphandle.
Inkulu kunazo zonke zikhona e-Asia, ngakumbi kwiIndiya naseChina. Iinkampani ezininzi ziphendulela ekugqibeleni abavelisi be-API njengoDkt. Reddy wokunciphisa iindleko kwizinto ezibiza kakhulu, abasebenzi kunye nezibonelelo.
Ngokucacileyo, i-AstraZeneca Pharmaceuticals isetyenziselwa ukuqhuba amaziko amaninzi okuvelisa eMelika. Ngoku, iipesenti ezi-15 ze-API zazo zenziwe kwi-US kwaye zikho izicwangciso zokuphelisa ipesenti ezincinci kunye nokukhupha zonke izinto ezenziwa ngaphandle kwezilwandle.
Mi miselo
Umgangatho wama-API unempembelelo ebalulekileyo ekusebenzeni nasekukhuselweni kwamachiza. Ama-API ayenzileyo okanye adibeneyo afakwe kwiinkalo ezinzulu, ezifana nezifo kunye nokufa.
Kwimeko yokugqithisa, ii-API zixhomekeke kwimimiselo equlathekileyo kunye nokuqwalasela kwilizwe abayithunyelwa kuyo. Ngokomzekelo, ii-API zokuvelisa izityalo ngaphesheya kolwandle ziyaqhubeka nokuhlolwa ngu-US Food & Drug Administration.
Njengoko kubonakaliswe ukudala ama-API, ishishini lokuxuba imveliso litshintsha ngokukhawuleza. Iinkampani asisayi kuthatha yonke inyathelo yenkqubo yokwenza iziyobisi, ekudaleni i-API ekwakheni i-capsule. Ukunciphisa iindleko kunye nokwandisa inzuzo, iinkampani sele ziqalise ukukhishwa kwe-APIs kubakhiqizi belizwe langaphandle aseAsia.
Nangona oku kuncedisile umgca wabo ophantsi, kukho ukukhathazeka okuqhubekayo malunga nomgangatho wale APIs oveliswa phesheya.
Ekuphenduleni, iibhunga ezilawulayo ezijongene nokukhuseleka kwesigulane, ezifana ne-FDA, ziye zaqalisa ukuboniswa okunamandla ukuqinisekisa ukuphucula imithi kunye nokukhusela iimpazamo. Ukuphambana naluphi na kule miqathango emiselweyo kunokubangelwa iintlawulo okanye ukukhumbula okubi kakhulu kwiinkampani zonyango emva kwale benzi.