Ngemva kokubuyekezwa okuqinile kwekomiti lochwepheshe le-US FDA (US Food and Drug Administration) inhlangano egunyaziwe, ngoMeyi 17, 2022, i-SyncoZymes (Shanghai) Co., Ltd. yathola ngokusemthethweni incwadi yokuqinisekisa ye-FDA (AKL): I-NMN impahla eluhlaza ngempumelelo. udlulise ukugunyazwa kwe-NDI (Isithako Esisha Sokudla).
Ngokwencwadi yokuqinisekisa yokwamukela ye-FDA's NDI, ngemuva kokuphela kwesikhathi sokuthula ngoJuni 5, 2022, izinto zokusetshenziswa ze-SyncoZymes's NMN zingasetshenziswa ngokusemthethweni ekukhiqizeni, ekuthengisweni, nasekukhuthazeni imikhiqizo yokunakekelwa kwezempilo e-United States.Futhi kusukela ngomhlaka-21 Juni 2022, ingatholakala kuwebhusayithi ethi www.regulations.gov njengesithasiselo esisha sokudla, inombolo 1247.
Mayelana nesitifiketi se-US FDA-NDI
I-FDA NDI iwuhlelo lokuqinisekisa olubalulekile lwemakethe yezengezo zokudla e-United States.Ukuze kwenganyelwe ukuphepha, ilebula ubuqiniso kanye nokumiswa kokukhiqizwa (GMP) emkhakheni wezithako zokudla, i-FDA iqale ngokusemthethweni umsebenzi we-NDI kusukela ngo-1994.
I-NDI isifinyezo se-New Dietary Ingredients.Ngokwezinhlinzeko ze-21 USC 350b(d) ye-Federal Food, Drug, and Cosmetic Act, uma inkampani ikholelwa ukuthi izithasiselo zokudla ezokwethula emakethe ziqukethe izithako zokudla ezintsha (kubhekiselwa kuzithako zika-1994 ezingakaveli imakethe ngaphambi komhla ziyi-15 kuMfumfu), inkampani kufanele ithumele umbiko kumphathi ophethe okungenani izinsuku ezingama-75 ngaphambi kokuba umkhiqizo ube semakethe, inikeze imininingwane yesithako esisha futhi ifakazele ukuthi kunezizathu zokulindela ukuthi isithako esisha siphephile umzimba womuntu ukumunca.
Ngaphezu kwemikhiqizo emisha ye-5,500 yokwengezwa kokudla kwethulwa e-United States unyaka ngamunye, noma kunjalo, eminyakeni engu-28 kusukela i-NDI yaqalwa, i-FDA ithole ngaphansi kwezaziso ze-NDI ze-1,300.Ezicelweni zesitifiketi se-NDI ezithunyelwa minyaka yonke, izinga lokuphasa le-FDA lokungaphikisani (AKL) lingu-39% kuphela.
Isitifiketi se-FDA NDI, uhlelo lokukhiqiza lwe-GMP
I-SyncoZymes ingumkhiqizi wokuqala emhlabeni ukuthola imvume ye-FDA NDI yezinto zokusetshenziswa ze-NMN.Ukugunyazwa kwale NDI akumeli nje kuphela ukugunyazwa kwe-FDA ngokuphepha kanye nekhwalithi yezinto zokusetshenziswa ze-NMN, kodwa futhi kumelela ukugunyazwa okusemthethweni yi-US FDA ukuthi i-NMN ingaba.Njengesithako sempahla eluhlaza sezithako zokudla e-United States. , lezi yizindaba ezinhle kakhulu zokuthuthukiswa kwemboni ye-NMN yomhlaba wonke, futhi kuwusizo ekuthuthukisweni okujwayelekile okuqhubekayo kwemboni ye-NMN ngokuhamba kwesikhathi.
I-SyncoZymes' NMN ihlelwa ngokohlelo lokukhiqiza lwe-GMP.Ukuze kuhlangatshezwane nesidingo semakethe esikhula ngokushesha, imikhiqizo yochungechunge lwe-SyncoZymes (Zhejiang) Co., Ltd. ye-NAD ihlanganisa indawo engamahektha angama-230.Ukwakhiwa kwephrojekthi eyisisekelo yokwenziwa kwezimboni zamakhemikhali kuqale ngoMeyi 2020, futhi indawo eyakhiwe kahle ye-NMN inamandla okukhiqiza amathani ayi-100.Iworkshop yokukhiqiza ihlelelwe ukuthi iqale ukukhiqiza ngo-2022.
I-Brand ye-NMN yokudayisa - "SyncoZymes®"
I-Syncozymes iphethe uhlobo lokuthengisa lwe-NMN, i-SyncoZymes®.Imikhiqizo ye-SyncoZymes® NMN yethulwe ku-Tmall Global, JD.com, kanye nezinhlelo ezincane ezisemthethweni eziwela umngcele we-WeChat.
Ngokuzayo, i-SyncoZymes izoqhubeka nokuhlola umphumela nendlela yezithako zemvelo empilweni yomuntu, ibone ukukhiqizwa kwezithako zemvelo eziluhlaza futhi inikeze abantu izixazululo zezempilo ezingokwesayensi, eziphephile nezisebenzayo, futhi izoqhubeka nokwenza imizamo engapheli yokuhlangabezana nezidingo. ukukhula kwezempilo emhlabeni jikelele kudinga umzamo!
Isikhathi sokuthumela: Aug-26-2022