KornnacCaps yakabudirira kupfuudza US FDA's DMF (Drug Master File) faira, ine nhamba yekuisa iri DMF#043237. Ichi chiitiko chinoratidza danho rakakosha mukuita kweKornnacCaps's internationalization process, sezvo zvigadzirwa zvayo zvakapinda zviri pamutemo kutevedzana kwekuwana musika weUS.
Kunyora kweDMF inzira yakakosha iyo US FDA inogadzirisa zvinhu zvakakosha zvakadai semishonga inobvisa mishonga uye inoshanda yemishonga yemishonga (APIs). Nekuisa iyo DMF, KornnacCaps yakaendesa dhata kuFDA maererano nemagadzirirwo ekugadzira, nzira dzekudzora mhando, uye nzvimbo nemidziyo tsananguro yeKornnacCaps yayo isina chinhu capsules. Mushure mekuongorora kwakaomarara kwemagwaro eDMF, iyo FDA yakasimbisa kuti KornnacCaps 'yekugadzira sisitimu, mhando manejimendi, uye kuchengetedzwa kwechigadzirwa zvinosangana nezvinodiwa zveUS, nekudaro ichipa nhamba yeDMF. Izvi zvinoreva kuti KornnacCaps macapsules anogona kushandiswa seanowanikwa zviri pamutemo nemakambani emishonga eUS mukugadzira zvinodhaka, achiisa hwaro hwezvinotevera dosage fomu zvigadzirwa kupinda mumusika weUS.
Semutengesi anotungamira weChinese wemacapsules asina chinhu, KornnacCaps yagara yakazvimisikidza seSevhisi Mupi weFunctional Capsule. Kambani yakagadzira hurongwa hwekutarisira hunhu zvinoenderana neCGMP zviyero uye yakawana zvitupa zvepasi rese seHALAL, Kosher, ISO9001, uye ISO22000, pamwe nekunyoreswa kweEU. Mutsetse wayo wechigadzirwa unosanganisira zvigadzirwa zvitsva zvakaita segelatin capsules, HPMC capsules, Halal capsules, Pullulan capsules, uye enteric-coated capsules, uye ine zvigadziriso zvehunyanzvi zvinozadzisa zvinodiwa nenyika dzepasi rese, sekusava netitanium dioxide uye sodium dodecyl sulfate. Chakanyanya kukosha, KornnacCaps capsules haashandise ethylene oxide kusterilization uye haina zvinodzivirira, izvo zvinosangana zvirinani nevatengi 'zvakasarudzika uye zvitsva zvekugadzira zvinodiwa.
Kubudirira kweiyi kufaira kweDMF hakusi kungozivikanwa zvine chiremera kweKornnacCaps 'simba rehunyanzvi uye nhanho yekutarisira mhando asiwo kubudirira kwakakosha kwehurongwa hwayo hwekudyidzana kwepasi rose. Parizvino, zvigadzirwa zveKornnacCaps zvasvika munyika yose uye zvinotengeswa kunyika dzinopfuura makumi maviri nematunhu anosanganisira Europe, United States, Southeast Asia, neAfrica. Muna 2024, kambani yakatamira kune imwe nzvimbo yakanaka yekupaka ine mari inosvika bhiriyoni imwe yeyuan, uye muna 2025, yakapedza kuvandudza mhando, ichivhura chitsauko chitsva pamusika paine-mufananidzo mutsva weKornnacCaps. Mune ramangwana,KornnacCapsicharamba ichitsigira pfungwa yehutungamiri hutsva, ichipa vatengi vepasi rose-makapisi emhando yepamusoro nemhinduro dzakagadzirirwa, uye kugadzira ramangwana rakajeka pamwe chete nevatengi.
