Bayan cikakken nazari daga kwamitin kwararru na hukumar kula da abinci da magunguna ta Amurka (FDA) a ranar 17 ga Mayu, 2022, SyncoZymes (Shanghai) Co., Ltd. ta karbi takardar tabbatarwa ta FDA (AKL) a hukumance: Kayan aikin NMN sun sami nasarar wuce amincewar NDI (Sabon Sinadarin Abinci).
A cewar wasiƙar tabbatar da amincewa da NDI ta FDA, bayan ƙarewar lokacin shiru a ranar 5 ga Yuni, 2022, ana iya amfani da kayan aikin SyncoZymes's NMN a hukumance wajen samarwa, tallace-tallace, da kuma tallata kayayyakin kiwon lafiya a Amurka. Hakanan daga ranar 21 ga Yuni, 2022, ana iya samunsa a gidan yanar gizon www.regulations.gov a matsayin sabon ƙarin abinci, mai lamba 1247.
Game da takardar shaidar FDA-NDI ta Amurka
FDA NDI muhimmin tsarin bayar da takardar shaida ne ga kasuwar kari na abinci a Amurka. Domin kula da aminci, sahihancin lakabi da daidaiton samarwa (GMP) a fannin kari na abinci, FDA ta fara aikin NDI a hukumance tun daga shekarar 1994.
NDI ita ce taƙaitacciyar Sabbin Sinadaran Abinci. A bisa tanadin 21 USC 350b(d) na Dokar Abinci, Magunguna, da Kayan Kwalliya ta Tarayya, idan kamfani ya yi imanin cewa ƙarin abincin da zai ƙaddamar a kasuwa ya ƙunshi sabbin sinadaran abinci (yana nufin sinadaran 1994 waɗanda ba su bayyana a kasuwa ba kafin 15 ga Oktoba), dole ne kamfanin ya gabatar da rahoto ga hukumar kulawa aƙalla kwanaki 75 kafin samfurin ya shigo kasuwa, yana ba da cikakkun bayanai game da sabon sinadarin kuma yana tabbatar da cewa akwai dalilan da za a yi tsammanin sabon sinadarin yana da lafiya ga jikin ɗan adam ya sha.
Ana ƙaddamar da sabbin kayayyakin abinci sama da 5,500 a 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 takardar shaidar NDI da aka gabatar kowace shekara, ƙimar izinin amincewa da rashin amincewa da FDA (AKL) shine kashi 39% kawai.
Takaddun shaida na FDA NDI, tsarin samar da GMP
SyncoZymes shine masana'anta ta farko a duniya da ta sami amincewar FDA NDI don kayan aikin NMN. Amincewar wannan NDI ba wai kawai tana wakiltar amincewar FDA don aminci da ingancin kayan aikin NMN ba, har ma tana wakiltar amincewar hukuma daga FDA ta Amurka cewa NMN na iya zama. A matsayin sinadari na kayan aikin abinci a Amurka, wannan babban labari ne mai kyau ga ci gaban masana'antar NMN ta duniya, kuma yana da amfani ga ci gaba da haɓaka masana'antar NMN a cikin dogon lokaci.
An tsara NMN na SyncoZymes bisa tsarin samar da kayayyaki na GMP. Domin biyan buƙatun kasuwa da ke ƙaruwa cikin sauri, kayayyakin jerin NAD na SyncoZymes (Zhejiang) Co., Ltd. sun mamaye faɗin eka 230. An fara gina aikin tushen masana'antar magunguna masu guba a watan Mayu na 2020, kuma cibiyar NMN da aka gina da kyau tana da ƙarfin samar da tan 100. An shirya fara samar da bitar a shekarar 2022.
Alamar NMN ta Siyarwa - "SyncoZymes®"
Syncozymes ne ke da kamfanin sayar da kayayyaki na NMN, SyncoZymes®. An ƙaddamar da kayayyakin SyncoZymes® NMN a kan ƙananan shirye-shiryen Tmall Global, JD.com, da WeChat na hukuma.
A nan gaba, SyncoZymes za ta ci gaba da binciko tasirin da sinadaran halitta ke yi wa lafiyar ɗan adam, ta hanyar samar da kayan halitta masu kore da kuma samar wa ɗan adam mafita ta kimiyya, aminci da inganci, kuma za ta ci gaba da yin ƙoƙari ba tare da gajiyawa ba don biyan buƙatun kiwon lafiya na duniya da ke ƙaruwa!
Lokacin Saƙo: Agusta-26-2022