Nyuma y’isuzuma rikomeye ryakozwe n’akanama k’inzobere k’umuryango w’ubutasi wa Amerika (US FDA) (US Food and Drug Administration), ku ya 17 Gicurasi 2022, SyncoZymes (Shanghai) Co., Ltd. yakiriye ku mugaragaro ibaruwa yemeza ya FDA (AKL): Ibikoresho fatizo bya NMN byemejwe na NDI (Ibikoresho bishya by’imirire).
Dukurikije ibaruwa yemeza ko NDI yatanzwe na FDA, nyuma y’uko igihe cyo guceceka kirangiye ku ya 5 Kamena 2022, ibikoresho fatizo bya SyncoZymes bya NMN bishobora gukoreshwa ku mugaragaro mu gukora, kugurisha no kwamamaza ibicuruzwa by’ubuvuzi muri Leta Zunze Ubumwe za Amerika. Nanone guhera ku ya 21 Kamena 2022, biboneka ku rubuga rwa www.regulations.gov nk'inyongera nshya y'ibiribwa, nimero 1247.
Ku bijyanye n'icyemezo cya FDA-NDI cyo muri Amerika
FDA NDI ni uburyo bw'ingenzi bwo kwemeza isoko ry'inyongeramusaruro muri Leta Zunze Ubumwe za Amerika. Mu rwego rwo kugenzura umutekano, ubuziranenge bw'ibirango n'amabwiriza agenga umusaruro (GMP) mu rwego rw'inyongeramusaruro, FDA yatangiye ku mugaragaro imirimo ya NDI kuva mu 1994.
NDI ni incamake y'ibice bishya by'ibiribwa. Dukurikije ingingo ya 21 USC 350b (d) y'Itegeko ry'Igihugu ry'Ibiribwa, Imiti, n'Ibyuma, niba isosiyete yemera ko inyongeramusaruro izatangiza ku isoko zirimo ibintu bishya by'ibiribwa (havugwa ibintu byo mu 1994 bitaragaragara ku isoko mbere y'itariki ya 15 Ukwakira), isosiyete igomba gutanga raporo ku rwego rw'ubuyobozi nibura iminsi 75 mbere yuko ibicuruzwa bijya ku isoko, igatanga ibisobanuro birambuye ku kintu gishya kandi ikagaragaza ko hari impamvu zo kwitega ko ikintu gishya gishobora kuzuzwa n'umubiri w'umuntu.
Muri Leta Zunze Ubumwe za Amerika hashyirwa ahagaragara ibinyobwa bishya birenga 5,500 buri mwaka, ariko, mu myaka 28 kuva NDI yatangizwa, FDA yakiriye ubutumwa bwa NDI buri munsi ya 1,300. Mu busabe bwo kwemeza NDI butangwa buri mwaka, igipimo cyo gutsinda cya FDA nta kibazo (AKL) ni 39% gusa.
Icyemezo cya FDA NDI, sisitemu yo gukora GMP
SyncoZymes niyo nganda ya mbere ku isi yemerewe na FDA NDI ku bikoresho fatizo bya NMN. Kwemerwa kwa NDI ntikwerekana gusa ko FDA yemereye umutekano n'ubwiza bw'ibikoresho fatizo bya NMN, ahubwo binagaragaza ko NMN yemerewe na FDA muri Amerika. Nk'ikintu cy'ibanze mu ntungamubiri z'inyongeramusaruro muri Leta Zunze Ubumwe za Amerika, iyi ni inkuru nziza ikomeye ku iterambere ry'inganda za NMN ku isi, kandi ni no gutuma inganda za NMN zikomeza gutera imbere mu buryo burambye.
NMN ya SyncoZymes itunganyijwe hakurikijwe uburyo bwo gukora GMP. Kugira ngo ihuze n'izamuka ry'ibiciro ku isoko, ibicuruzwa bya SyncoZymes (Zhejiang) Co., Ltd. bipima ubuso bwa hegitari 230. Kubaka umushinga w'inganda zikora imiti y'imiti byatangiye muri Gicurasi 2020, kandi ikigo cya NMN cyubatswe neza gifite ubushobozi bwo gukora toni 100. Biteganijwe ko ikigo gishinzwe gukora kizatangira gukora mu 2022.
Ikirango cya NMN cy'ubucuruzi - "SyncoZymes®"
Syncozymes ifite ikirango cya NMN, SyncoZymes®. Ibicuruzwa bya SyncoZymes® NMN byashyizwe ahagaragara kuri Tmall Global, JD.com, na gahunda nto zemewe za WeChat zikorera mu bihugu bitandukanye.
Mu gihe kiri imbere, SyncoZymes izakomeza gusuzuma ingaruka n'imikorere y'ibintu karemano ku buzima bw'abantu, imenye uko ibintu karemano bikorerwa kandi bigatanga ibisubizo by'ubuvuzi bya siyansi, bihamye kandi bifite akamaro, kandi izakomeza gushyira imbaraga mu guhaza imbaraga zikomeje kwiyongera ku isi mu bijyanye n'ubuzima!
Igihe cyo kohereza: Kanama-26-2022