Ma hope o ka loiloi koʻikoʻi e ke komite ʻoihana o ka US FDA (US Food and Drug Administration) hui mana, ma Mei 17, 2022, SyncoZymes (Shanghai) Co., Ltd. ua loaʻa ʻole ka palapala hōʻoia a ka FDA (AKL): NMN raw material successfully ua ʻae ʻia ka NDI (New Dietary Ingredient).
Wahi a ka palapala hōʻoia hōʻoia ʻana o ka NDI a ka FDA, ma hope o ka pau ʻana o ka manawa hāmau ma Iune 5, 2022, hiki ke hoʻohana ʻia nā mea maka NMN o SyncoZymes i ka hana ʻana, kūʻai aku, a me ka hoʻolaha ʻana i nā huahana mālama olakino ma United States.E hoʻomaka ana i Iune 21, 2022, hiki ke ʻike ʻia ma ka pūnaewele www.regulations.gov ma ke ʻano he mea hoʻohui meaʻai hou, helu 1247.
E pili ana i ka palapala hōʻoia US FDA-NDI
He ʻōnaehana hōʻoia koʻikoʻi ʻo FDA NDI no ka mākeke hoʻohui meaʻai ma ʻAmelika Hui Pū ʻIa.I mea e kiaʻi ai i ka palekana, hōʻailona i ka ʻoiaʻiʻo a me ka standardization hana (GMP) ma ke kahua o nā mea hoʻohui meaʻai, ua hoʻomaka ʻo FDA i ka hana NDI mai 1994.
ʻO NDI ka pōkole o New Dietary Ingredients.Wahi a nā ʻōlelo o 21 USC 350b (d) o ka Federal Food, Drug, and Cosmetic Act, inā manaʻo kahi hui i nā mea hoʻohui meaʻai e hoʻomaka ai ma ka mākeke he mau meaʻai meaʻai hou (e pili ana i nā meaʻai 1994 i ʻike ʻole ʻia ma ka mākeke ma mua o ʻOkakopa 15), pono ka ʻoihana e waiho i kahi hōʻike i ka mana hoʻomalu ma kahi o 75 mau lā ma mua o ka kūʻai ʻana o ka huahana ma ka mākeke, e hāʻawi ana i nā kikoʻī o ka mea hou a hōʻoia ʻia aia nā kumu e manaʻo ai ua palekana ka mea hou. kino kanaka e omo.
ʻOi aku ma mua o 5,500 mau huahana meaʻai meaʻai hou i hoʻokuʻu ʻia ma ʻAmelika Hui Pū ʻIa i kēlā me kēia makahiki, akā naʻe, i nā makahiki 28 mai ka hoʻomaka ʻana o NDI, ua loaʻa i ka FDA ma lalo o 1,300 NDI hoʻolaha.Ma nā palapala palapala hōʻoia NDI i waiho ʻia i kēlā me kēia makahiki, ʻo ka FDA no objection response (AKL) pass rate he 39% wale nō.
Palapala hōʻoia FDA NDI, ʻōnaehana hana GMP
ʻO SyncoZymes ka mea hana mua ma ka honua e loaʻa i ka FDA NDI apono no NMN raw material.ʻO ka ʻae ʻia ʻana o kēia NDI ʻaʻole ia e hōʻike wale i ka ʻae ʻia o ka FDA no ka palekana a me ka maikaʻi o nā mea waiwai NMN, akā hōʻike pū kekahi i ka ʻae ʻia e ka US FDA e hiki ai iā NMN ke lilo. , He nūhou maikaʻi nui kēia no ka hoʻomohala ʻana i ka ʻoihana NMN honua, a he mea kūpono hoʻi ia i ka hoʻomohala mau ʻana o ka ʻoihana NMN i ka wā lōʻihi.
Hoʻonohonoho ʻia ʻo SyncoZymes 'NMN e like me kahi ʻōnaehana hana GMP.No ka hoʻokō ʻana i ka noi mākeke e ulu wikiwiki nei, ʻo SyncoZymes (Zhejiang) Co., Ltd.'s NAD series huahana uhi kahi o 230 ʻeka.Ua hoʻomaka ke kūkulu ʻia ʻana o ka papahana hoʻonaʻauao lāʻau kemika ma Mei 2020, a ʻo ka hale NMN i kūkulu maikaʻi ʻia he 100 tons.Hoʻomaka ka papa hana hana e hoʻomaka i ka hana ma 2022.
Kahua NMN kūʻai kūʻai - "SyncoZymes®"
Loaʻa iā Syncozymes ka brand NMN kūʻai, ʻo SyncoZymes®.Ua hoʻokuʻu ʻia nā huahana SyncoZymes® NMN ma Tmall Global, JD.com, a me WeChat i nā papahana mini cross-border.
I ka wā e hiki mai ana, e hoʻomau ʻo SyncoZymes i ka ʻimi ʻana i ka hopena a me ke ʻano o nā mea kūlohelohe i ke olakino kanaka, ʻike i ka hana ʻōmaʻomaʻo o nā mea kūlohelohe a hāʻawi i nā kānaka me nā ʻepekema, palekana a maikaʻi hoʻi i nā hopena olakino, a e hoʻomau i ka hoʻoikaika mau ʻana e hālāwai me ka ʻO ka ulu ʻana o ke olakino honua pono e hoʻoikaika!
Ka manawa hoʻouna: ʻAukake-26-2022