Ngemva kokubuyekezwa okuqinile yikomidi lochwepheshe lenhlangano enegunya le-US FDA (US Food and Drug Administration), ngoMeyi 17, 2022, i-SyncoZymes (Shanghai) Co., Ltd. yamukele ngokusemthethweni incwadi yokuqinisekisa ye-FDA (AKL): Izinto zokusetshenziswa ze-NMN ziphumelele ukuvunyelwa yi-NDI (New Dietary Ingredient).
Ngokusho kwencwadi yokuqinisekisa ukwamukelwa kwe-NDI ye-FDA, ngemuva kokuphela kwesikhathi sokuthula ngoJuni 5, 2022, izinto zokusetshenziswa ze-SyncoZymes ze-NMN zingasetshenziswa ngokusemthethweni ekukhiqizweni, ekuthengisweni, nasekukhuthazeni imikhiqizo yokunakekelwa kwempilo e-United States. Futhi kusukela ngoJuni 21, 2022, ingatholakala kuwebhusayithi ethi www.regulations.gov njengesengezo sokudla esisha, inombolo 1247.
Mayelana nesitifiketi se-FDA-NDI sase-US
I-FDA NDI uhlelo olubalulekile lokuqinisekisa imakethe yezithako zokudla e-United States. Ukuze kuqondiswe ukuphepha, ubuqiniso belebula kanye nokuqiniswa kokukhiqiza (i-GMP) emkhakheni wezithako zokudla, i-FDA yaqala ngokusemthethweni umsebenzi we-NDI kusukela ngo-1994.
I-NDI isifinyezo seZithako Ezintsha Zokudla. Ngokwemibandela ye-21 USC 350b(d) ye-Federal Food, Drug, and Cosmetic Act, uma inkampani ikholelwa ukuthi izithako zokudla ezizokwethula emakethe ziqukethe izithako zokudla ezintsha (ngokubhekisela ezingxenyeni zika-1994 ezingazange zivele emakethe ngaphambi kuka-Okthoba 15), inkampani kumele ithumele umbiko egunyeni eliphethe okungenani izinsuku ezingu-75 ngaphambi kokuba umkhiqizo ufike emakethe, inikeze imininingwane yesithako esisha futhi ifakazele ukuthi kunezizathu zokulindela ukuthi isithako esisha siphephile ukuthi umzimba womuntu usimunce.
Imikhiqizo emisha yokudla engaphezu kuka-5,500 yethulwa e-United States minyaka yonke, nokho, eminyakeni engama-28 selokhu kwaqalwa i-NDI, i-FDA ithole izaziso ze-NDI ezingaphansi kuka-1,300. Ezicelweni zesitifiketi se-NDI ezithunyelwa minyaka yonke, izinga lokuphasa le-FDA lokuphendula okungenakuphikiswa (i-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. Ukuvunyelwa kwale NDI akumeli nje kuphela imvume ye-FDA ngokuphepha kanye nekhwalithi yezinto zokusetshenziswa ze-NMN, kodwa futhi kumele imvume esemthethweni yi-US FDA yokuthi i-NMN ingaba yini. Njengesithako sezinto zokusetshenziswa zezithako zokudla e-United States, lokhu kuyizindaba ezinhle kakhulu zokuthuthukiswa komkhakha we-NMN womhlaba wonke, futhi kusiza ekuthuthukisweni okuqhubekayo okujwayelekile komkhakha we-NMN ngokuhamba kwesikhathi.
I-NMN ye-SyncoZymes ihlelwe ngokwesistimu yokukhiqiza ye-GMP. Ukuze kuhlangatshezwane nesidingo semakethe esikhula ngokushesha, imikhiqizo yochungechunge lwe-NAD ye-SyncoZymes (Zhejiang) Co., Ltd. imboza indawo engamahektare angama-230. Ukwakhiwa kwephrojekthi yesisekelo sezimboni zemithi yamakhemikhali kuqalile ngoMeyi 2020, kanti isikhungo se-NMN esakhiwe kahle sinamandla okukhiqiza angamathani ayi-100. Indawo yokusebenzela yokukhiqiza ihlelelwe ukuqala ukukhiqiza ngo-2022.
Umkhiqizo we-NMN Wokuthengisa - "i-SyncoZymes®"
I-Syncozymes ingumnikazi womkhiqizo we-NMN, i-SyncoZymes®. Imikhiqizo ye-SyncoZymes® NMN yethulwe ku-Tmall Global, JD.com, kanye nezinhlelo ezincane ezisemthethweni ze-WeChat.
Esikhathini esizayo, i-SyncoZymes izoqhubeka nokuhlola umphumela kanye nendlela izithako zemvelo ezisebenza ngayo empilweni yabantu, iqaphele ukukhiqizwa okuluhlaza kwezithako zemvelo futhi inikeze abantu izixazululo zempilo zesayensi, eziphephile nezisebenzayo, futhi izoqhubeka nokwenza imizamo engapheli yokuhlangabezana nezidingo zempilo zomhlaba wonke ezikhulayo!
Isikhathi sokuthunyelwe: Agasti-26-2022