Tom qab kev tshuaj xyuas nruj los ntawm pawg neeg tshaj lij ntawm US FDA (US Food and Drug Administration) lub koom haum muaj cai, thaum Lub Tsib Hlis 17, 2022, SyncoZymes (Shanghai) Co., Ltd. tau txais tsab ntawv lees paub ntawm FDA (AKL): NMN cov khoom siv raw tau dhau NDI (New Dietary Ingredient) kev pom zoo.
Raws li tsab ntawv lees paub lees txais NDI ntawm FDA, tom qab lub sijhawm ntsiag to tas sij hawm rau lub Rau Hli 5, 2022, SyncoZymes cov khoom siv raw NMN tuaj yeem siv tau rau hauv kev tsim khoom, kev muag khoom, thiab kev txhawb nqa cov khoom kho mob hauv Tebchaws Meskas. Tsis tas li ntawd pib txij lub Rau Hli 21, 2022, nws tuaj yeem pom ntawm lub vev xaib www.regulations.gov ua cov khoom noj khoom haus tshiab, tus lej 1247.
Txog daim ntawv pov thawj FDA-NDI ntawm Tebchaws Meskas
FDA NDI yog ib qho kev lees paub tseem ceeb rau kev lag luam khoom noj khoom haus hauv Tebchaws Meskas. Txhawm rau saib xyuas kev nyab xeeb, daim ntawv lo thiab kev tsim khoom (GMP) hauv kev lag luam khoom noj khoom haus, FDA tau pib ua haujlwm NDI txij li xyoo 1994.
NDI yog lub npe luv ntawm Cov Khoom Xyaw Noj Tshiab. Raws li cov kev cai ntawm 21 USC 350b(d) ntawm Tsoom Fwv Teb Chaws Cov Khoom Noj, Tshuaj, thiab Kev Zoo Nkauj, yog tias lub tuam txhab ntseeg tias cov khoom noj khoom haus uas nws yuav tso tawm hauv khw muaj cov khoom xyaw noj haus tshiab (hais txog cov khoom xyaw xyoo 1994 uas tsis tau tshwm sim hauv khw ua ntej Lub Kaum Hli 15), lub tuam txhab yuav tsum xa daim ntawv qhia rau lub koom haum saib xyuas tsawg kawg 75 hnub ua ntej cov khoom lag luam tso tawm hauv khw, muab cov ntsiab lus ntawm cov khoom xyaw tshiab thiab ua pov thawj tias muaj cov laj thawj xav tias cov khoom xyaw tshiab no muaj kev nyab xeeb rau tib neeg lub cev nqus tau.
Txhua xyoo muaj ntau tshaj 5,500 yam khoom noj khoom haus tshiab tau tsim tawm hauv Tebchaws Meskas, txawm li cas los xij, hauv 28 xyoo txij li thaum NDI tau pib, FDA tau txais tsawg dua 1,300 daim ntawv ceeb toom NDI. Hauv cov ntawv thov daim ntawv pov thawj NDI xa txhua xyoo, FDA tsis muaj lus teb tsis pom zoo (AKL) tus nqi dhau tsuas yog 39%.
FDA NDI daim ntawv pov thawj, GMP ntau lawm system
SyncoZymes yog thawj lub chaw tsim khoom hauv ntiaj teb kom tau txais kev pom zoo los ntawm FDA NDI rau cov khoom siv raw NMN. Kev pom zoo ntawm NDI no tsis yog tsuas yog sawv cev rau kev pom zoo los ntawm FDA rau kev nyab xeeb thiab zoo ntawm cov khoom siv raw NMN, tab sis kuj sawv cev rau kev pom zoo los ntawm US FDA tias NMN tuaj yeem yog. Raws li cov khoom siv raw ntawm cov khoom noj khoom haus hauv Tebchaws Meskas, qhov no yog xov xwm zoo rau kev txhim kho kev lag luam NMN thoob ntiaj teb, thiab nws kuj tseem pab txhawb rau kev txhim kho tus qauv ntawm kev lag luam NMN mus ntev.
SyncoZymes' NMN tau teeb tsa raws li GMP txoj kev tsim khoom. Txhawm rau kom tau raws li qhov kev thov ntawm kev ua lag luam uas loj hlob sai, SyncoZymes (Zhejiang) Co., Ltd. cov khoom NAD series npog thaj tsam ntawm 230 daim av. Kev tsim kho ntawm qhov project kev lag luam tshuaj lom neeg tau pib thaum lub Tsib Hlis 2020, thiab lub chaw NMN uas tau tsim zoo muaj peev xwm tsim khoom ntawm 100 tons. Lub chaw ua haujlwm tsim khoom tau teem sijhawm pib tsim khoom hauv xyoo 2022.
Hom NMN Muag Khoom - "SyncoZymes®"
Syncozymes yog tus tswv ntawm lub khw muag khoom NMN, SyncoZymes®. Cov khoom SyncoZymes® NMN tau tso tawm rau ntawm Tmall Global, JD.com, thiab WeChat cov kev pab cuam me me hla ciam teb.
Yav tom ntej, SyncoZymes yuav txuas ntxiv tshawb nrhiav cov txiaj ntsig thiab cov txheej txheem ntawm cov khoom xyaw ntuj tsim rau tib neeg kev noj qab haus huv, paub txog kev tsim cov khoom xyaw ntuj tsim thiab muab rau tib neeg cov kev daws teeb meem kev noj qab haus huv, kev nyab xeeb thiab zoo, thiab yuav txuas ntxiv ua haujlwm tas mus li kom tau raws li kev xav tau kev noj qab haus huv thoob ntiaj teb!
Lub sijhawm tshaj tawm: Lub Yim Hli-26-2022