Mgbe kọmitii ọkachamara nke ụlọ ọrụ US FDA (US Food and Drug Administration) nyochachara nke ọma, na Mee 17, 2022, SyncoZymes (Shanghai) Co., Ltd. natara akwụkwọ nkwenye nke FDA (AKL) n'ihu ọha: NMN ihe eji emepụta ihe gafere nkwenye NDI (New Dietary Ingredient) nke ọma.
Dịka akwụkwọ nkwenye nnabata NDI nke FDA si kwuo, mgbe oge ịgbachi nkịtị ahụ gwụchara na June 5, 2022, enwere ike iji ihe eji emepụta NMN nke SyncoZymes mee ihe n'ụzọ iwu kwadoro na mmepụta, ire ere, na nkwalite nke ngwaahịa nlekọta ahụike na United States. Malite na June 21, 2022, enwere ike ịchọta ya na weebụsaịtị www.regulations.gov dị ka mgbakwunye nri ọhụrụ, nọmba 1247.
Banyere asambodo FDA-NDI nke US
FDA NDI bụ usoro asambodo dị mkpa maka ahịa mgbakwunye nri na United States. Iji hụ na nchekwa, izi ezi na nhazi mmepụta (GMP) dị n'ọhịa nke mgbakwunye nri, FDA malitere ọrụ NDI n'ihu ọha kemgbe 1994.
NDI bụ mkpọbiri nke ihe oriri ọhụrụ. Dịka iwu nke 21 USC 350b(d) nke Iwu Nri, Ọgwụ, na Ịchọ Mma nke Federal si dị, ọ bụrụ na ụlọ ọrụ ekwere na ihe mgbakwunye nri ọ ga-ewepụta n'ahịa nwere ihe oriri ọhụrụ (na-ezo aka na ihe ndị e ji mee ihe na 1994 nke na-apụtabeghị n'ahịa tupu Ọktoba 15), ụlọ ọrụ ahụ ga-enyefe akụkọ nye ndị na-ahụ maka nlekọta ma ọ dịkarịa ala ụbọchị 75 tupu ngwaahịa ahụ abanye n'ahịa, na-enye nkọwa nke ihe ọhụrụ ahụ ma na-egosi na e nwere ihe mere a ga-eji tụọ anya na ihe ọhụrụ ahụ dị mma maka ahụ mmadụ ịmịkọrọ.
A na-ewepụta ihe karịrị ngwaahịa mgbakwunye nri ọhụrụ 5,500 na United States kwa afọ, agbanyeghị, n'ime afọ 28 kemgbe e hiwere NDI, FDA enwetabeghị ọkwa NDI 1,300. N'akwụkwọ anamachọihe asambodo NDI nke a na-enye kwa afọ, ọnụego ngafe FDA no objection response (AKL) bụ naanị 39%.
Asambodo FDA NDI, sistemụ mmepụta GMP
SyncoZymes bụ onye nrụpụta mbụ n'ụwa nwetara nkwenye FDA NDI maka ihe eji emepụta NMN. Nkwenye nke NDI a abụghị naanị na ọ na-anọchite anya nkwenye nke FDA maka nchekwa na ịdị mma nke ihe eji emepụta NMN, kamakwa ọ na-anọchite anya nkwenye gọọmentị nke US FDA na NMN nwere ike ịbụ. Dịka ihe eji emepụta ihe eji emepụta ihe eji eme nri na United States, nke a bụ nnukwu akụkọ dị mma maka mmepe nke ụlọ ọrụ NMN zuru ụwa ọnụ, ọ na-enyekwa aka na mmepe ọkọlọtọ na-aga n'ihu nke ụlọ ọrụ NMN n'ikpeazụ.
A haziri NMN nke SyncoZymes dịka usoro mmepụta GMP si dị. Iji mezuo ọchịchọ ahịa na-eto ngwa ngwa, ngwaahịa NAD nke SyncoZymes (Zhejiang) Co., Ltd. na-ekpuchi mpaghara nke eka 230. Ọrụ owuwu nke ntọala ụlọ ọrụ mmepụta ọgwụ kemịkalụ amalitela na Mee 2020, ebe NMN arụrụ nke ọma nwere ikike mmepụta nke tọn 100. A na-ahazi ogbako mmepụta ahụ ịmalite mmepụta na 2022.
Akara NMN Ahịa - "SyncoZymes®"
Syncozymes nwere akara NMN nke ụlọ ahịa, SyncoZymes®. A malitela ngwaahịa SyncoZymes® NMN na mmemme obere ndị ọrụ Tmall Global, JD.com, na WeChat.
N'ọdịnihu, SyncoZymes ga-aga n'ihu na-enyocha mmetụta na usoro nke ihe ndị sitere n'okike na ahụike mmadụ, mezuo mmepụta akwụkwọ ndụ akwụkwọ ndụ nke ihe ndị sitere n'okike ma nye ụmụ mmadụ ngwọta ahụike sayensị, nchekwa na nke dị irè, ma ga-aga n'ihu na-eme mgbalị siri ike iji gboo mkpa ahụike zuru ụwa ọnụ na-eto eto!
Oge ozi: Ọgọst-26-2022