Pambuyo powunikanso mosamala ndi komiti ya akatswiri ya bungwe lovomerezeka la US FDA (US Food and Drug Administration), pa Meyi 17, 2022, SyncoZymes (Shanghai) Co., Ltd. idalandira kalata yotsimikizira ya FDA (AKL): Zinthu zopangira za NMN zidapambana chivomerezo cha NDI (New Dietary Ingredient).
Malinga ndi kalata yotsimikizira kuvomereza kwa NDI ya FDA, nthawi ya chete itatha pa June 5, 2022, zinthu zopangira za SyncoZymes's NMN zitha kugwiritsidwa ntchito mwalamulo popanga, kugulitsa, ndi kutsatsa zinthu zachipatala ku United States. Komanso kuyambira pa June 21, 2022, zitha kupezeka patsamba la www.regulations.gov ngati chowonjezera chatsopano cha zakudya, nambala 1247.
Za satifiketi ya FDA-NDI ku US
FDA NDI ndi njira yofunika kwambiri yotsimikizira msika wa zowonjezera zakudya ku United States. Pofuna kuyang'anira chitetezo, kutsimikizika kwa zilembo ndi muyezo wopanga (GMP) m'munda wa zowonjezera zakudya, FDA idayamba ntchito ya NDI kuyambira 1994.
NDI ndi chidule cha Zakudya Zatsopano. Malinga ndi zomwe zili mu 21 USC 350b(d) ya Federal Food, Drug, and Cosmetic Act, ngati kampani ikukhulupirira kuti zakudya zowonjezera zomwe idzayambitsa pamsika zili ndi zosakaniza zatsopano (ponena za zosakaniza za 1994 zomwe sizinawonekere pamsika pasanafike pa 15 Okutobala), kampaniyo iyenera kupereka lipoti kwa oyang'anira osachepera masiku 75 malonda asanafike pamsika, kupereka tsatanetsatane wa chosakaniza chatsopano ndikutsimikizira kuti pali zifukwa zoyembekezera kuti chosakaniza chatsopanocho ndi chotetezeka kuti thupi la munthu lizimwe.
Zakudya zowonjezera zakudya zoposa 5,500 zimayambitsidwa ku United States chaka chilichonse, komabe, m'zaka 28 kuyambira pomwe NDI idakhazikitsidwa, FDA yalandira zidziwitso zosakwana 1,300 za NDI. Mu ma fomu opempha satifiketi ya NDI omwe amaperekedwa chaka chilichonse, chiwopsezo cha FDA chopanda kutsutsa (AKL) ndi 39% yokha.
Satifiketi ya FDA NDI, njira yopangira GMP
SyncoZymes ndiye wopanga woyamba padziko lonse lapansi kupeza chilolezo cha FDA NDI cha zinthu zopangira NMN. Kuvomerezedwa kwa NDI kumeneku sikungoyimira kuvomerezedwa kwa FDA pa chitetezo ndi ubwino wa zinthu zopangira NMN, komanso kuyimira kuvomerezedwa kovomerezeka ndi US FDA kuti NMN ikhoza kukhala. Monga chosakaniza cha zinthu zopangira zakudya ku United States, iyi ndi nkhani yabwino kwambiri pakukula kwa makampani apadziko lonse a NMN, ndipo imathandizanso kuti makampani a NMN azikula bwino pakapita nthawi.
NMN ya SyncoZymes imakonzedwa motsatira njira yopangira ya GMP. Pofuna kukwaniritsa zosowa za msika zomwe zikukula mofulumira, zinthu za NAD za SyncoZymes (Zhejiang) Co., Ltd. zimaphimba malo okwana maekala 230. Ntchito yomanga pulojekiti yopangira mankhwala osokoneza bongo yayamba mu Meyi 2020, ndipo malo omangidwa bwino a NMN ali ndi mphamvu yopangira matani 100. Malo opangira zinthu akukonzekera kuyamba kupanga mu 2022.
Mtundu wa NMN Wogulitsa - "SyncoZymes®"
Syncozymes ndiye mwini wa kampani yogulitsa zinthu ya NMN, SyncoZymes®. Zinthu za SyncoZymes® NMN zatulutsidwa pa Tmall Global, JD.com, ndi mapulogalamu ang'onoang'ono ovomerezeka a WeChat.
M'tsogolomu, SyncoZymes ipitiliza kufufuza momwe zosakaniza zachilengedwe zimakhudzira thanzi la anthu, kuzindikira kupanga zosakaniza zachilengedwe moyenera komanso kupatsa anthu mayankho asayansi, otetezeka komanso ogwira mtima pazaumoyo, ndipo ipitiliza kuyesetsa mosalekeza kukwaniritsa zosowa zathanzi padziko lonse lapansi!
Nthawi yotumizira: Ogasiti-26-2022