Bayan cikakken nazari da kwamitocin ƙwararrun ƙungiyar FDA ta Amurka (Hukumar Abinci da Magunguna ta Amurka) mai iko, a ranar 17 ga Mayu, 2022, SyncoZymes (Shanghai) Co., Ltd. ta karɓi takardar tabbatar da FDA a hukumance (AKL): NMN albarkatun ƙasa cikin nasara. sun wuce amincewar NDI (Sabon Abincin Abinci).
Dangane da wasiƙar tabbatar da karɓar NDI ta FDA, bayan ƙarewar lokacin shiru a kan Yuni 5, 2022, SyncoZymes's NMN albarkatun kasa za a iya amfani da su bisa hukuma wajen samarwa, tallace-tallace, da haɓaka samfuran kula da lafiya a cikin Amurka.Hakanan farawa daga Yuni 21, 2022, ana iya samunsa akan gidan yanar gizon www.regulations.gov azaman sabon ƙarin kayan abinci, lamba 1247.
Game da takardar shedar FDA-NDI ta Amurka
FDA NDI muhimmin tsarin takaddun shaida ne don kasuwar ƙarin kayan abinci a cikin Amurka.Don sa ido kan aminci, sanya alamar sahihanci da daidaiton samarwa (GMP) a fagen abubuwan abinci, FDA a hukumance ta fara aikin NDI tun 1994.
NDI ita ce taƙaitawar Sabbin Sinadaran Abinci.Dangane da tanade-tanaden 21 USC 350b (d) na Dokar Abinci, Drug, da Cosmetic ta Tarayya, idan kamfani ya yi imanin cewa ƙarin abincin da zai ƙaddamar a kasuwa ya ƙunshi sabbin kayan abinci na abinci (yana nufin abubuwan 1994 waɗanda ba su bayyana akan su ba. kasuwa kafin Oktoba 15), dole ne kamfanin ya gabatar da rahoto ga hukumar kulawa aƙalla kwanaki 75 kafin samfurin ya kasance a kasuwa, yana ba da cikakkun bayanai game da sabon sashi da kuma tabbatar da cewa akwai dalilan da za a sa ran sabon sinadarin yana da aminci ga samfuran. jikin mutum ya sha.
Fiye da 5,500 sabbin kayan kari na abinci ana ƙaddamar da su a cikin Amurka kowace shekara, duk da haka, a cikin shekaru 28 tun lokacin da aka ƙaddamar da NDI, FDA ta sami ƙasa da sanarwar NDI 1,300.A cikin aikace-aikacen takaddun shaida na NDI da aka ƙaddamar kowace shekara, FDA babu amsawar ƙin yarda (AKL) ƙimar wucewa shine kawai 39%.
FDA NDI takardar shaida, GMP samar da tsarin
SyncoZymes shine masana'anta na farko a duniya don samun izinin FDA NDI don albarkatun albarkatun NMN.Amincewa da wannan NDI ba wai kawai yana wakiltar amincewar FDA don aminci da ingancin albarkatun kasa na NMN ba, amma kuma yana wakiltar amincewar hukuma ta FDA ta Amurka cewa NMN na iya zama. , wannan babban labari ne mai kyau ga ci gaban masana'antar NMN ta duniya, kuma yana da kyau ga ci gaba da daidaiton ci gaban masana'antar NMN a cikin dogon lokaci.
An shirya SyncoZymes'NMN bisa ga tsarin samar da GMP.Domin saduwa da buƙatun kasuwa na haɓaka cikin sauri, samfuran SyncoZymes (Zhejiang) Co., Ltd.'s NAD jerin samfuran sun mamaye yanki mai girman eka 230.An fara aikin ginin tushen masana'antar magungunan sinadarai a watan Mayu 2020, kuma ginin da aka gina mai kyau na NMN yana da karfin samar da tan 100.An shirya taron bitar samarwa don fara samarwa a cikin 2022.
Alamar NMN Retail - "SyncoZymes®"
Syncozymes ya mallaki alamar NMN dillali, SyncoZymes®.An ƙaddamar da samfuran NMN na SyncoZymes® akan Tmall Global, JD.com, da WeChat na hukuma ƙananan shirye-shiryen giciye.
A nan gaba, SyncoZymes za ta ci gaba da yin la'akari da tasiri da tsarin sinadaran halitta a kan lafiyar ɗan adam, gane koren masana'anta na kayan halitta da kuma samar wa 'yan adam hanyoyin kimiyya, aminci da ingantattun hanyoyin kiwon lafiya, kuma za su ci gaba da yin ƙoƙari mai yawa don saduwa da haɓaka kiwon lafiyar duniya yana buƙatar ƙoƙari!
Lokacin aikawa: Agusta-26-2022