Mushure mekuongororwa kwakasimba nekomiti yehunyanzvi yesangano rine simba reUS FDA (US Food and Drug Administration), musi wa17 Chivabvu 2022, SyncoZymes (Shanghai) Co., Ltd. yakagamuchira zviri pamutemo tsamba yekusimbisa yeFDA (AKL): NMN raw material yakabudirira kupasa NDI (New Dietary Ingredient).
Sekureva kwetsamba yekusimbisa kugamuchira NDI yeFDA, mushure mekupera kwenguva yekunyarara musi wa5 Chikumi 2022, zvinhu zveSyncoZymes's NMN zvinogona kushandiswa zviri pamutemo mukugadzira, kutengesa, uye kushambadza zvigadzirwa zvehutano muUnited States. Zvakare kutanga musi wa21 Chikumi 2022, zvinogona kuwanikwa pawebhusaiti ye www.regulations.gov sechikafu chitsva, nhamba 1247.
Nezve US FDA-NDI certification
FDA NDI inzira yakakosha yekupa zvitupa kumusika wezvekudya zvinovaka muviri muUnited States. Kuti itarisire kuchengetedzeka, kuvimbika kwemazita uye kuyera kugadzirwa (GMP) mumunda wezvekudya zvinovaka muviri, FDA yakatanga zviri pamutemo basa reNDI kubvira muna 1994.
NDI ipfupiso yeZvinhu Zvitsva Zvekudya. Zvichienderana nechikamu che21 USC 350b(d) cheFederal Food, Drug, and Cosmetic Act, kana kambani ichitenda kuti zvekudya zvinovaka muviri zvayavachatanga pamusika zvine zvinhu zvitsva zvekudya (zvichireva zvinhu zve1994 zvisati zvaonekwa pamusika Gumiguru 15 risati rasvika), kambani inofanirwa kuendesa mushumo kuvakuru vekutarisira kwemazuva makumi manomwe nemashanu chigadzirwa chisati chasvika pamusika, ichipa ruzivo rwechinhu chitsva ichi uye ichiratidza kuti pane zvikonzero zvekutarisira kuti chinhu chitsva chakachengeteka kuti muviri wemunhu unye.
Zvigadzirwa zvitsva zvinodarika 5,500 zvekudya zvinotangwa muUnited States gore rega rega, zvisinei, mumakore makumi maviri nemasere kubvira pakatanga NDI, FDA yakagamuchira zviziviso zveNDI zvisingasviki 1,300. Muzvikumbiro zveNDI zvinopihwa gore rega rega, mwero wekupasa weFDA hapana objection response (AKL) i39% chete.
Chitupa cheFDA NDI, sisitimu yekugadzira GMP
SyncoZymes ndiyo kambani yekutanga pasi rose kuwana mvumo yeFDA NDI yezvinhu zveNMN. Kubvumidzwa kweNDI iyi hakungomiriri chete mvumo yeFDA yekuchengetedzeka uye mhando yezvinhu zveNMN, asiwo kunomiririra mvumo yepamutemo yeUS FDA iyo NMN inogona kuva. Sechinhu chisina kugadzirwa chezvinowedzera zvekudya muUnited States, iyi inhau huru yakanaka yekuvandudzwa kweindasitiri yepasi rose yeNMN, uye inobatsirawo kuti indasitiri yeNMN irambe ichikura zvakanaka kwenguva refu.
NMN yeSyncoZymes yakarongwa zvichienderana nehurongwa hwekugadzira hweGMP. Kuti ikwanise kusangana nekudiwa kwemusika kuri kukura nekukurumidza, zvigadzirwa zveSyncoZymes (Zhejiang) Co., Ltd. zveNAD zvinofukidza nzvimbo yemaeka mazana maviri nemakumi matatu. Kuvakwa kwepurojekiti yekugadzira mishonga yemakemikari kwakatanga muna Chivabvu 2020, uye nzvimbo yeNMN yakavakwa zvakanaka ine kugona kwekugadzira matani zana. Musangano wekugadzira wakarongerwa kutanga kugadzirwa muna 2022.
Rudzi rweNMN rwekutengesa - "SyncoZymes®"
Syncozymes ndiyo ine kambani yeNMN, SyncoZymes®. Zvigadzirwa zveSyncoZymes® NMN zvakatangwa paTmall Global, JD.com, uye mapurogiramu madiki epamutemo eWeChat.
Mune ramangwana, SyncoZymes icharamba ichiongorora mashandiro anoita zvinhu zvakasikwa pahutano hwevanhu, kuona kugadzirwa kwezvinhu zvakasikwa uye kupa vanhu mhinduro dzesainzi, dzakachengeteka uye dzinoshanda dzehutano, uye icharamba ichiedza nemoyo wese kusangana nezvinodiwa zvehutano pasi rose zviri kukura!
Nguva yekutumira: Nyamavhuvhu-26-2022