I-KornnacCaps idlulise ngempumelelo ifayela le-DMF (Drug Master File) le-US FDA, nenombolo yokugcwalisa ithi DMF#043237. Lesi senzakalo esiyingqopha-mlando siphawula isinyathelo esibalulekile enqubweni ye-KornnacCaps yokwenziwa kwamanye amazwe, njengoba imikhiqizo yayo ingene ngokusemthethweni ekulandeleni ukuthobela imithetho yokufinyelela ezimakethe zase-US.
Ukufakwa kwe-DMF kuyindlela ebalulekile lapho i-US FDA ilawula ngayo izinto ezibalulekile njengezisiza ezenza imithi kanye nezithako ezisebenzayo zemithi (ama-API). Ngokufaka i-DMF, i-KornnacCaps ithumele idatha ewumsuka ku-FDA mayelana nenqubo yokukhiqiza, izindlela zokulawula ikhwalithi, nezincazelo zesikhungo nemishini yamakhepsuli ayo angenalutho e-KornnacCaps. Ngemva kokubuyekezwa okuqinile kwamadokhumenti e-DMF, i-FDA yaqinisekisa ukuthi uhlelo lokukhiqiza lwe-KornnacCaps, uhlelo lokuphatha ikhwalithi, nokuphepha komkhiqizo kuhlangabezana nezidingo zokulawula zase-US, ngaleyo ndlela inikeze inombolo ye-DMF. Lokhu kusho ukuthi amaphilisi e-KornnacCaps angasetshenziswa njengabasizi abasemthethweni yizinkampani zemithi zase-US ekukhiqizeni izidakamizwa, nokubeka isisekelo semikhiqizo yefomu lomthamo olandelayo ukuze ingene emakethe yase-US.
Njengomphakeli ohamba phambili waseShayina wamaphilisi angenalutho, i-KornnacCaps ibihlezi izibeka njengomhlinzeki Wesevisi we-Functional Capsule. Inkampani isungule uhlelo lokuphatha ikhwalithi ngokuhambisana namazinga e-cGMP futhi ithole izitifiketi zamazwe ngamazwe njenge-HALAL, i-Kosher, i-ISO9001, ne-ISO22000, kanye nokubhaliswa kwe-EU. Ulayini wayo womkhiqizo uhlanganisa imikhiqizo emisha efana namaphilisi e-gelatin, amaphilisi e-HPMC, amaphilisi e-Halal, amaphilisi e-Pullulan, nama-capsules{4}}ahlanganiswe nge-enteric, futhi inezixazululo zobuchwepheshe ezihlangabezana nezimfuneko zokulawula zamazwe ngamazwe, njengokungabi nayo i-titanium dioxide ne-sodium dodecyl sulfate. Okubaluleke kakhulu, amaphilisi e-KornnacCaps awasebenzisi i-ethylene oxide ukuze avale inzalo futhi awaqukethe izivimbelakuvunda, ezihlangabezana kangcono nezidingo zamakhasimende zokwakheka komuntu siqu nokusungula izinto ezintsha.
Impumelelo yalokhu kufakwa kwe-DMF akukhona nje kuphela ukuqashelwa okugunyaziwe kwamandla ezobuchwepheshe e-KornnacCaps nezinga lokuphatha ikhwalithi kodwa futhi kuyinzuzo ebalulekile yesu layo lokuhwebelana kwembulunga yonke. Njengamanje, imikhiqizo ye-KornnacCaps isifinyelele ezweni lonke futhi ithunyelwa emazweni angaphezu kuka-20 nasezifundeni ezihlanganisa i-Europe, i-United States, i-Southeast Asia, kanye ne-Afrika. Ngo-2024, inkampani yathuthela epaki entsha ehlakaniphile enesamba sokutshalwa kwezimali kwebhiliyoni elingu-1, kwathi ngo-2025, yaqeda ukuthuthukiswa komkhiqizo, yavula isahluko esisha emakethe ngesithombe{6}}esitsha se-KornnacCaps. Esikhathini esizayo,KornnacCapssizoqhubeka nokusekela umqondo wobuholi bokusungula, sinikeze amakhasimende omhlaba{0}amakhephuseli ekhwalithi ephezulu nezisombululo ezenziwe ngokwezifiso, nokudala ikusasa eliqhakazile kanye namakhasimende.
