Hubei JXBio Pharmaceutical Co., Ltd., saịtị mmepụta peptide nke JYMed raara onwe ya nye, mezuru nyocha ọzọ na saịtị nke US Food and Drug Administration (FDA) site na Machị 10-14. Nlele ahụ, akụkụ nke nyocha mmesi obi ike ọgwụ, nyochara sistemu isi gụnyere ogo, mmepụta, akụrụngwa na akụrụngwa, njikwa ụlọ nyocha na njikwa ihe. API nyochara gụnyere Liraglutide, Semaglutide, Tirzepatide, na Oxytocin.

N'ịgbaso nyocha ahụ, FDA nyere onye ọrụ gọọmentị Establishment Inspection Report (EIR), na-akwado na ọrụ Hubei JXBio na-ezute ụkpụrụ dị elu nke ụlọ ọrụ maka ịdị mma na nnabata.

Nke a bụ akara nyocha FDA nke abụọ na-esochi nke ụlọ ọrụ Hubei anyị gafere, na-ekwughachi nkwa anyị na sistemu klaasị ụwa. Ọ na-emeghekwa ụzọ maka ndebanye aha ngwaahịa zuru ụwa ọnụ ma na-ewusi ọnọdụ anyị ike na ahịa peptide mba ụwa.

Banyere JYMed

JYMed bụ ụlọ ọrụ na-emepụta ọgwụ dị elu nke ọkachamara na nyocha, mmepe, mmepụta na ịzụ ahịa nke ngwaahịa ndị dabeere na peptide. Anyị na-enyekwa ọrụ CDMO ngwụcha ruo ngwụcha, na-enye ihe ngwọta peptide ahaziri maka ndị ahịa ọgwụ, ịchọ mma na ọgwụgwọ anụmanụ n'ụwa niile.

Pọtụfoliyo ngwaahịa anyị gụnyere ọtụtụ API peptide. Ngwaahịa ọkọlọtọ dị ka Semaglutide na Terlipressin emechaala ntinye akwụkwọ US FDA DMF nke ọma.

Enyemaka anyị niile nwere, Hubei JXBio, na-arụ ọrụ ahịrị mmepụta peptide API dị mkpụmkpụ emebere iji zute ụkpụrụ cGMP nke US FDA na NMPA nke China setịpụrụ. Ihe owuwu ahụ gụnyere ahịrị mmepụta 10 buru ibu na nke pilot, nke usoro njikwa ogo ọgwụ siri ike (QMS) kwadoro yana mmemme ahụike na nchekwa gburugburu ebe obibi siri ike (EHS).

JXBio agafeela nyocha GMP site na US FDA na NMPA nke China wee mara ya site n'aka ndị isi ụlọ ọrụ na-ahụ maka ọgwụ zuru ụwa ọnụ maka ịdị mma na njikwa EHS, na-egosipụta nkwenye siri ike anyị maka ịdịmma, nchekwa, na nlekọta gburugburu ebe obibi.

Mpaghara azụmahịa isi

• ndebanye aha zuru ụwa ọnụ na nrube isi maka peptide API

• Ọgwụ anụmanụ na ihe ịchọ mma peptide

• Mmepe peptide omenala na nrụpụta (CRO, CMO, OEM)

• Peptide-ọgwụ conjugates (PDCs), gụnyere:

• Peptide-radionuclide conjugates

• Peptide-obere njikọ molekul

• Peptide-protein conjugates

• ọgwụgwọ peptide-RNA

Isi ngwaahịa

Maka ozi ndị ọzọ gbasara ngwaahịa anyị, biko kpọtụrụ anyị:

API zuru ụwa ọnụ na ajụjụ ịchọ mma: +86-150-1352-9272

Ndebanye aha API & Ọrụ CDMO (ahịa US na EU): +86-158-1868-2250

Email:jymed@jymedtech.com

Adreesị: Ụlọ elu 8 & 9, Ụlọ 1, Shenzhen Biomedical Innovation Industrial Park,

14 Jinhui Road, Kengzi Subdistrict, Pingshan District, Shenzhen, China