Emva kokuphononongwa ngokungqongqo yikomiti yobungcali yombutho ogunyazisiweyo we-US FDA (US Food and Drug Administration), ngoMeyi 17, 2022, iSyncoZymes (Shanghai) Co., Ltd. yafumana ngokusesikweni ileta yokuqinisekisa ye-FDA (AKL): Izinto eziluhlaza ze-NMN ziphumelele ngempumelelo imvume ye-NDI (New Dietary Ingredient).
Ngokweleta yokuqinisekisa ukwamkelwa kwe-NDI ye-FDA, emva kokuphela kwexesha lokuthula nge-5 kaJuni 2022, izinto ezikrwada ze-SyncoZymes ze-NMN zingasetyenziswa ngokusesikweni kwimveliso, ukuthengisa, kunye nokukhuthaza iimveliso zokhathalelo lwempilo e-United States. Kwakhona ukususela nge-21 kaJuni 2022, inokufumaneka kwiwebhusayithi ye-www.regulations.gov njengesongezelelo esitsha sokutya, inombolo 1247.
Malunga nesatifikethi se-FDA-NDI saseMelika
I-FDA NDI yinkqubo ebalulekileyo yokuqinisekisa kwimarike ye-dietary supplement eMelika. Ukuze kujongwe ukhuseleko, ubunyani beelebheli kunye nomgangatho wemveliso (GMP) kwicandelo le-dietary supplements, i-FDA yaqala ngokusesikweni umsebenzi we-NDI ukusukela ngo-1994.
I-NDI sisifinyezo seZithako Ezintsha Zokutya. Ngokwemimiselo ye-21 USC 350b(d) yoMthetho wezoKutya, amayeza, kunye neZithambiso zeSizwe, ukuba inkampani ikholelwa ukuba izongezo zokutya eza kuziqalisa kwimarike ziqulathe izithako ezintsha zokutya (ngokubhekiselele kwizithako zika-1994 ezingakhange zivele kwimarike ngaphambi komhla we-15 kweyeDwarha), inkampani kufuneka ingenise ingxelo kwigunya elilawulayo ubuncinane iintsuku ezingama-75 ngaphambi kokuba imveliso ithengiswe, inike iinkcukacha zesithako esitsha kwaye ibonise ukuba kukho izizathu zokulindela ukuba isithako esitsha sikhuselekile ukuba umzimba womntu usifumane.
Iimveliso ezintsha zezongezo zokutya ezingaphezu kwama-5,500 ziyaqaliswa eMelika minyaka le, nangona kunjalo, kwiminyaka engama-28 ukusukela oko kwaqaliswa i-NDI, i-FDA ifumene izaziso ze-NDI ezingaphantsi kwe-1,300. Kwizicelo zesatifikethi se-NDI ezifakwa minyaka le, izinga lokupasa le-FDA lokuphendula ngaphandle kokuphikiswa (AKL) liyi-39% kuphela.
Isatifikethi se-FDA NDI, inkqubo yemveliso ye-GMP
I-SyncoZymes ngumvelisi wokuqala emhlabeni ukufumana imvume ye-FDA NDI yezinto ezikrwada ze-NMN. Imvume yale NDI ayimeli nje kuphela imvume ye-FDA yokhuseleko kunye nomgangatho wezinto ezikrwada ze-NMN, kodwa ikwamela imvume esemthethweni yi-US FDA yokuba i-NMN inokuba yiyo. Njengesithako sezinto ezikrwada zezongezo zokutya e-United States, le yindaba entle kakhulu kuphuhliso lweshishini le-NMN lehlabathi, kwaye ikwanceda kuphuhliso oluqhubekayo olusemgangathweni lweshishini le-NMN ekuhambeni kwexesha.
I-NMN yeSyncoZymes icwangciswe ngokwenkqubo yemveliso ye-GMP. Ukuze kuhlangatyezwane neemfuno zemarike ezikhula ngokukhawuleza, iimveliso ze-NASD zeSyncoZymes (Zhejiang) Co., Ltd. zigubungela ummandla weehektare ezingama-230. Ukwakhiwa kweprojekthi yesiseko soshishino lwamayeza eekhemikhali kuqalile ngoMeyi 2020, kwaye iziko le-NMN elakhiwe kakuhle linomthamo wemveliso weetoni ezili-100. Indawo yokusebenzela yemveliso icwangciselwe ukuqala imveliso ngo-2022.
Uhlobo lweNMN lokuThengisa - "SyncoZymes®"
I-Syncozymes ingumnini we-NMN brand, i-SyncoZymes®. Iimveliso ze-SyncoZymes® NMN ziqalisiwe kwi-Tmall Global, JD.com, kunye neenkqubo ezincinci ezisemthethweni ze-WeChat.
Kwixesha elizayo, iSyncoZymes iza kuqhubeka nokuphonononga impembelelo kunye nendlela ezisebenza ngayo izithako zemvelo kwimpilo yabantu, iqonde indlela eziveliswa ngayo izithako zemvelo ngendlela eluhlaza kwaye inike abantu izisombululo zempilo zesayensi, ezikhuselekileyo nezisebenzayo, kwaye iza kuqhubeka nokwenza imizamo engapheliyo yokuhlangabezana neemfuno zempilo zehlabathi ezikhulayo!
Ixesha lokuthumela: Agasti-26-2022