KornnacCaps ye Ameriki FDA ka DMF (Drug Master File) sɛbɛn tɛmɛn ka ɲɛ, a sɛbɛn nimɔrɔ ye DMF#043237 ye. Nin ko in ye senna-tɛgɛrɛba ye KornnacCaps ka diɲɛnatigɛ taabolo la, bawo a ka fɛn dilannenw donna sariya labatoli siratigɛ la foroba la Ameriki suguya sɔrɔli kama.
DMF filen ye fɛɛrɛ nafamaba ye, Ameriki FDA bɛ fɛn kolomaw labɛn min fɛ i n’a fɔ furakɛli dɛmɛnanw ani furakɛlifɛnw (API). DMF bilali fɛ, KornnacCaps ye kunnafoni jɔnjɔnw di FDA ma, minnu ɲɛsinnen bɛ a ka KornnacCaps furakisɛ lankolonw dilanni taabolo ma, u jogoɲini fɛɛrɛw, ani u yɔrɔw ni u minɛnw ɲɛfɔli. DMF sɛbɛnw lajɛli kɔfɛ kosɛbɛ, FDA y’a jira ko KornnacCaps ka fɛn dilanni siratigɛ, a ka jogoɲumanya siratigɛ la, ani a ka fɛn dilannenw lakanani bɛ Ameriki sariyaw ka wajibiw dafa, o la, a ye DMF nimɔrɔ di. O kɔrɔ ye ko KornnacCaps furakisɛw bɛ se ka kɛ dɛmɛnan sariyalenw ye Ameriki furakɛlitɔnw fɛ fura dilanni na, o bɛ kɛ sababu ye ka fura tata hakɛ nataw furaw jusigilan bila ka don Ameriki sugu la.
I n’a fɔ Sinuwa jamana min ye furakisɛ lankolonw feerela ŋana ye, KornnacCaps y’a yɛrɛ bila tuma bɛɛ i n’a fɔ furakisɛ baarakɛta baarakɛla. Sosiyete in ye jogoɲumanya ɲɛnabɔcogo dɔ sigi senkan ka kɛɲɛ ni cGMP sariyaw ye, wa a ye diɲɛ seereyaw sɔrɔ i n’a fɔ HALAL, Kosher, ISO9001, ani ISO22000, ka fara UE tɔgɔsɛbɛnni kan. A ka fɛn dilannenw kɔnɔ, fɛn kuraw bɛ sɔrɔ i n’a fɔ jelatɛni furakisɛw, HPMC furakisɛw, Halal furakisɛw, Pullulan furakisɛw, ani kɔnɔbara{4}}kisɛw minnu datugulen don, wa a bɛ ni fɛɛrɛ kuraw ye minnu bɛ diɲɛ sariyaw ka ɲininiw dafa, i n’a fɔ a tɛ sɔrɔ titaniyɔmu gazi ni sodiyɔmu dodesili sulfate la. Min nafa ka bon kosɛbɛ, o ye ko KornnacCaps furakisɛw tɛ baara kɛ ni etilɛni ɔkisidi ye walasa ka sterilize kɛ, wa u tɛ fɛnɲɛnamafagalanw sɔrɔ, o min bɛ kiliyanw ka furakɛli magow ɲɛ ka ɲɛ, minnu bɛ kɛ u yɛrɛ ye ani minnu bɛ kɛ ni fɛn kuraw ye.
Nin DMF sɛbɛn in ɲɛtaa tɛ dan KornnacCaps ka fɛɛrɛbɔ fanga n’a ka jogoɲumanya ɲɛnabɔli hakɛ dɔnni ye ni fanga ye, nka a ye a ka diɲɛnatigɛ fɛɛrɛ in sɔrɔli nafama fana ye. Sisan, KornnacCaps ka fɛn dilannenw sera jamana bɛɛ ma, wa u bɛ taa jamana ni mara 20 ni kɔ la i n’a fɔ Erɔpu, Ameriki, Azi saheli-kɔrɔnfɛla, ani Afiriki. San 2024, a ka tɔn in jiginna ka taa nakɔsɛnɛyɔrɔ kura hakilitigi dɔ la ni wari bɛɛ lajɛlen ye miliyari 1 ye, wa san 2025, a ye fɛntigiya sɛnɛcogo dɔ dafa, ka sapitiri kura da wuli sugu la ni KornnacCaps ja kura ye min tɔgɔ ye ko-. Don nataw la, .KornnacCaps ka baarabɛna t’a fɛ ka kokuradon ɲɛmɔgɔya hakilina sabati, ka diɲɛ kiliyanw dɛmɛ ni furakisɛw ye minnu ka ɲi kosɛbɛ ani fura minnu bɛ kɛ ka kɛɲɛ ni mɔgɔw sago ye, ani ka siniɲɛsigi ɲuman dilan ɲɔgɔn fɛ ni kiliyanw ye.
