Nyuma yo gusuzumwa neza na komite yumwuga y’umuryango w’ububasha muri Amerika FDA (US Food and Drug Administration), ku ya 17 Gicurasi 2022, SyncoZymes (Shanghai) Co., Ltd. yakiriye ku mugaragaro ibaruwa yemeza FDA (AKL): Ibikoresho fatizo bya NMN byatsinze yatsinze NDI (Ibiribwa bishya).
Nk’uko bigaragara mu ibaruwa yemeza ko FDA yemeye NDI, nyuma y’igihe cyo guceceka ku ya 5 Kamena 2022, ibikoresho fatizo bya NMN bya SyncoZymes bishobora gukoreshwa ku mugaragaro mu bicuruzwa, kugurisha, no kuzamura ibicuruzwa by’ubuzima muri Amerika.Guhera kandi ku ya 21 Kamena 2022, urashobora kubisanga kurubuga rwa www.regulations.gov nkinyongera yimirire mishya, nimero 1247.
Ibyerekeye icyemezo cya Amerika FDA-NDI
FDA NDI ni gahunda yingenzi yo kwemeza isoko ryongera ibiryo muri Amerika.Mu rwego rwo kugenzura umutekano, label yukuri no kugena umusaruro (GMP) mubijyanye ninyongera zimirire, FDA yatangiye imirimo ya NDI kuva 1994.
NDI ni impfunyapfunyo y'ibikoresho bishya by'imirire.Dukurikije ibivugwa muri 21 USC 350b (d) y’Itegeko ry’ibiribwa, ibiyobyabwenge, n’amavuta yo kwisiga, niba isosiyete yemera ko inyongeramusaruro y’imirire izatangiza ku isoko irimo ibintu bishya by’imirire (bivuga ibintu 1994 bitigeze bigaragara kuri isoko mbere yitariki ya 15 Ukwakira), isosiyete igomba gutanga raporo kubuyobozi bugenzura byibura iminsi 75 mbere yuko ibicuruzwa bigurishwa ku isoko, bitanga ibisobanuro birambuye kubintu bishya kandi byerekana ko hari impamvu zo gutegereza ko ibintu bishya bifite umutekano kuri umubiri w'umuntu gukurura.
Ibicuruzwa bishya byongera ibiryo birenga 5.500 bishyirwa ahagaragara muri Amerika buri mwaka, nyamara, mumyaka 28 kuva NDI yatangira, FDA yakiriye imenyekanisha ritari munsi ya 1300 NDI.Mubisabwa byemeza NDI byatanzwe buri mwaka, FDA nta gisubizo cyo kwanga (AKL) igipimo cya 39% gusa.
Icyemezo cya FDA NDI, sisitemu yo gukora GMP
SyncoZymes niyambere ikora kwisi yabonye ibyemezo bya FDA NDI kubikoresho fatizo bya NMN.Iyemezwa ryiyi NDI ntabwo ryerekana gusa kwemeza FDA kumutekano nubuziranenge bwibikoresho fatizo bya NMN, ahubwo binagaragaza icyemezo cyemejwe na FDA yo muri Amerika ko NMN ishobora kuba.Nkibikoresho fatizo byongera ibiryo muri Amerika. , iyi ni inkuru nziza yiterambere ryiterambere ryinganda za NMN kwisi yose, kandi ifasha kandi iterambere rihoraho ryiterambere ryinganda za NMN mugihe kirekire.
NMN ya SyncoZymes yateguwe ukurikije sisitemu yo gukora GMP.Mu rwego rwo guhaza isoko ryihuta ryiyongera ku isoko, SyncoZymes (Zhejiang) Co, Ltd. ibicuruzwa bya NAD bikurikirana bifite ubuso bwa hegitari 230.Kubaka umushinga w’inganda zishingiye ku miti y’imiti byatangiye muri Gicurasi 2020, kandi ikigo cya NMN cyubatswe neza gifite umusaruro wa toni 100.Biteganijwe ko amahugurwa y’umusaruro azatangira umusaruro mu 2022.
Gucuruza NMN Ikirango - "SyncoZymes®"
Syncozymes ifite ibicuruzwa NMN icuruza, SyncoZymes®.Ibicuruzwa bya SyncoZymes® NMN byatangijwe kuri Tmall Global, JD.com, na WeChat yemewe ya mini mini yambukiranya imipaka.
Mu bihe biri imbere, SyncoZymes izakomeza gucukumbura ingaruka nuburyo bwibintu karemano byubuzima bwabantu, bamenye icyatsi kibisi cyibintu karemano kandi biha abantu ibisubizo byubuzima byubumenyi, umutekano kandi byiza, kandi bizakomeza gukora ibishoboka byose kugirango bahure nu kwiyongera k'ubuzima ku isi bikeneye imbaraga!
Igihe cyo kohereza: Kanama-26-2022