Emva kokuphononongwa ngokungqongqo yikomiti yobungcali ye-US FDA (US Food and Drug Administration) umbutho ogunyazisiweyo, ngoMeyi 17, 2022, SyncoZymes (Shanghai) Co., Ltd. ifumene ngokusemthethweni ileta yokuqinisekisa ye-FDA (AKL): I-NMN impahla eluhlaza ngempumelelo. idlulile i-NDI (iSithako esitsha seDietary) imvume.
Ngokutsho kwe-FDA ye-NDI yokwamkelwa ileta yokwamkelwa, emva kokuphela kwexesha lokuthulisa ngoJuni 5, 2022, izixhobo ze-NMN ze-SyncoZymes zingasetyenziswa ngokusemthethweni kwimveliso, ukuthengisa, kunye nokukhuthazwa kweemveliso zokhathalelo lwempilo e-United States.Kwakhona ukuqala nge-21 kaJuni ka-2022, inokufumaneka kwiwebhusayithi ethi www.regulations.gov njengesongezo esitsha sokutya, inombolo 1247.
Malunga ne-US FDA-NDI isatifikethi
I-FDA NDI yinkqubo yoqinisekiso olubalulekileyo lwentengiso yezongezo zokutya e-United States.Ukuze ujonge ukhuseleko, ukunyaniseka kweleyibhile kunye nomgangatho wokuvelisa (GMP) kwintsimi yezongezo zokutya, i-FDA iqalise ngokusemthethweni umsebenzi we-NDI ukususela kwi-1994.
I-NDI sisishunqulelo seZithako eziTsha zokutya.Ngokutsho kwezibonelelo ze-21 USC 350b (d) ye-Federal Food, Drug, kunye ne-Cosmetic Act, ukuba inkampani ikholelwa ukuba izongezo zokutya eziza kuzisungula kwimarike ziqulethe izithako zokutya ezintsha (ngokubhekiselele kwizithako ze-1994 ezingakhange zivele imarike phambi kwe-15 ka-Okthobha), inkampani kufuneka ingenise ingxelo kugunyaziwe olawulayo ubuncinane kwiintsuku ezingama-75 phambi kokuba imveliso ibe kwimarike, inika iinkcukacha zesithako esitsha kwaye ingqina ukuba kukho izizathu zokulindela ukuba isithako esitsha sikhuselekile umzimba womntu ukufunxa.
Ngaphezulu kweemveliso ze-5,500 ezitsha zokuncedisa ukutya ziqaliswa e-United States ngonyaka ngamnye, nangona kunjalo, kwiminyaka eyi-28 ukususela ekubeni i-NDI yaqaliswa, i-FDA ifumene ngaphantsi kwe-1,300 ye-NDI izaziso.Kwizicelo zokuqinisekiswa kwe-NDI ezifakwe rhoqo ngonyaka, i-FDA akukho mpendulo yokuchasa (AKL) izinga lokupasa kuphela i-39%.
Ukuqinisekiswa kwe-FDA NDI, inkqubo yokuvelisa i-GMP
I-SyncoZymes ngumenzi wokuqala emhlabeni ukufumana imvume ye-FDA NDI kwizinto ezikrwada ze-NMN.Ukuvunywa kwale NDI akubonisi kuphela imvume ye-FDA yokhuseleko kunye nomgangatho wezinto eziluhlaza ze-NMN, kodwa ikwamele ukuvunywa ngokusemthethweni yi-US FDA ukuba i-NMN ingaba.Njengesithako sezinto eziluhlaza zezongezo zokutya e-United States. , ezi ziindaba ezilungileyo ezingundoqo kuphuhliso lweshishini lehlabathi le-NMN, kwaye ikwaluncedo kuphuhliso olusemgangathweni oluqhubekayo lweshishini le-NMN ekuhambeni kwexesha.
I-SyncoZymes 'NMN ihlelwe ngokwenkqubo yemveliso ye-GMP.Ukuze kuhlangatyezwane nemfuno yemarike ekhula ngokukhawuleza, i-SyncoZymes (Zhejiang) Co., Ltd. yeemveliso zothotho lwe-NAD zigubungela indawo yeehektare ezingama-230.Ulwakhiwo lwesiseko seprojekthi yoshishino lweziyobisi lwemichiza luqale ngoMeyi 2020, kwaye indawo eyakhiwe kakuhle ye-NMN inomthamo wokuvelisa iitoni ezili-100.Iworkshop yemveliso icwangciselwe ukuqala imveliso ngo-2022.
Intengiso yeNMN Brand - "SyncoZymes®"
I-Syncozymes ingumnini wentengiso ye-NMN brand, SyncoZymes®.Iimveliso ze-SyncoZymes® ze-NMN ziqaliswe kwi-Tmall Global, i-JD.com, kunye ne-WeChat ezisemthethweni iinkqubo ezincinci zokuwela umda.
Kwixesha elizayo, i-SyncoZymes iya kuqhubeka nokuphonononga umphumo kunye nendlela yezithako zendalo kwimpilo yabantu, iqonde ukuveliswa kwezinto eziluhlaza kunye nokubonelela abantu ngezisombululo zezempilo zesayensi, ezikhuselekileyo nezisebenzayo, kwaye iya kuqhubeka nokwenza imizamo engapheliyo ukuhlangabezana ukukhula kwempilo yehlabathi kufuna inzame!
Ixesha lokuposa: Aug-26-2022