Hubei JXBio Pharmaceutical Co., Ltd., Aaye iṣelọpọ peptide iyasọtọ ti JYMed, ṣaṣeyọri aṣeyọri ayewo miiran lori aaye nipasẹ Ile-iṣẹ Ounje ati Oògùn AMẸRIKA (FDA) lati Oṣu Kẹta Ọjọ 10-14. Ayewo naa, apakan ti iṣayẹwo Didara Didara Oògùn, ṣe iṣiro awọn eto bọtini pẹlu didara, iṣelọpọ, ohun elo ati awọn ohun elo, awọn iṣakoso lab, ati iṣakoso ohun elo. Awọn API ti a ṣe ayẹwo pẹlu Liraglutide, Semaglutide, Tirzepatide, ati Oxytocin.

Ni atẹle ayewo naa, FDA ti gbejade ijabọ Ayẹwo Idasile ti oṣiṣẹ (EIR), ti o jẹrisi pe awọn iṣẹ ṣiṣe ti Hubei JXBio pade awọn iṣedede giga ti ile-ibẹwẹ fun didara ati ibamu.

Eyi jẹ ami ayẹwo FDA itẹlera keji ti o kọja nipasẹ ile-iṣẹ Hubei wa, n ṣe idaniloju ifaramo wa si iṣelọpọ kilasi agbaye ati awọn eto didara. O tun ṣe ọna fun iforukọsilẹ ọja agbaye ni irọrun ati mu ipo wa lagbara ni ọja peptide agbaye.

Nipa JYMed

JYMed jẹ ile-iṣẹ elegbogi ti imọ-ẹrọ giga ti o ṣe amọja ni iwadii, idagbasoke, iṣelọpọ, ati iṣowo ti awọn ọja ti o da lori peptide. A tun pese awọn iṣẹ CDMO ipari-si-opin, nfunni ni awọn solusan peptide ti a ṣe deede si awọn oogun, ohun ikunra, ati awọn alabara ti ogbo ni kariaye.

Ọja wa portfolio pẹlu dosinni ti peptide APIs. Awọn ọja asia gẹgẹbi Semaglutide ati Terlipressin ti pari ni ifijišẹ US FDA DMF iforuko.

Ile-iṣẹ ohun-ini wa patapata, Hubei JXBio, n ṣiṣẹ awọn laini iṣelọpọ peptide API gige-eti ti a ṣe apẹrẹ lati pade awọn iṣedede cGMP ti a ṣeto nipasẹ mejeeji US FDA ati China's NMPA. Ohun elo naa pẹlu iwọn-nla 10 ati awọn laini iṣelọpọ iwọn-awaoko, ni atilẹyin nipasẹ eto iṣakoso didara elegbogi lile (QMS) ati eto ilera ati ailewu ayika ti o lagbara (EHS).

JXBio ti kọja awọn ayewo GMP nipasẹ mejeeji US FDA ati China's NMPA ati pe o jẹ idanimọ nipasẹ oludari awọn ile-iṣẹ elegbogi agbaye fun didara julọ ni iṣakoso EHS, ti n ṣe afihan ifaramo ailopin wa si didara, ailewu, ati iriju ayika.

Mojuto Business Area

• Iforukọsilẹ agbaye ati ibamu ilana fun awọn API peptide

• Ti ogbo ati ohun ikunra awọn ọja peptide

• Idagbasoke peptide aṣa ati iṣelọpọ (CRO, CMO, OEM)

• Awọn conjugates-oògùn Peptide (PDCs), pẹlu:

• Peptide–radionuclide conjugates

• Peptide – awọn conjugates moleku kekere

• Peptide – amuaradagba conjugates

• Awọn itọju ailera Peptide-RNA

Ọja akọkọ

Fun alaye diẹ sii nipa awọn ọja wa, jọwọ kan si wa:

API Àgbáyé àti Àwọn Ìbéèrè Ìkọsimetik: +86-150-1352-9272

Iforukọsilẹ API & Awọn iṣẹ CDMO (Awọn ọja AMẸRIKA ati EU): +86-158-1868-2250

Imeeli:jymed@jymedtech.com

Adirẹsi: Awọn ilẹ ipakà 8 & 9, Ilé 1, Shenzhen Biomedical Innovation Industrial Park,

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