ʻO Hubei JXBio Pharmaceutical Co., Ltd., kahi kahua hana peptide i hoʻolaʻa ʻia e JYMed, ua hoʻopau maikaʻi ʻia kahi nānā ʻana ma ka pūnaewele e ka US Food and Drug Administration (FDA) mai Malaki 10-14. ʻO ka nānā ʻana, he ʻāpana o ka loiloi ʻana i ka lāʻau lapaʻau, loiloi i nā ʻōnaehana koʻikoʻi me ka maikaʻi, ka hana ʻana, nā lako a me nā pono, nā mana lab, a me ka hoʻokele waiwai. ʻO nā API i loiloi ʻia me Liraglutide, Semaglutide, Tirzepatide, a me Oxytocin.

Ma hope o ka nānā ʻana, ua hoʻopuka ka FDA i kahi hōʻike ʻo Establishment Inspection Report (EIR), e hōʻoia ana e hoʻokō nā hana a Hubei JXBio i nā kūlana kiʻekiʻe o ke keʻena no ka maikaʻi a me ka hoʻokō.

ʻO kēia ka mākaʻikaʻi ʻelua o ka FDA i hoʻoholo ʻia e kā mākou hale Hubei, e hōʻoiaʻiʻo ana i kā mākou kūpaʻa ʻana i ka hana honua a me nā ʻōnaehana maikaʻi. Hāʻawi ia i ke ala no ka hoʻopaʻa inoa ʻana o nā huahana honua a hoʻoikaika i ko mākou kūlana i ka mākeke peptide honua.

E pili ana iā JYMed

ʻO JYMed kahi hui lāʻau lapaʻau kiʻekiʻe i ka noiʻi, hoʻomohala, hana, a me ke kālepa ʻana o nā huahana peptide. Hāʻawi pū mākou i nā lawelawe CDMO hopena, hāʻawi i nā hoʻonā peptide i hoʻohālikelike ʻia i nā mea kūʻai lāʻau lapaʻau, cosmetic, a me nā holoholona holoholona ma ka honua holoʻokoʻa.

Loaʻa i kā mākou waihona huahana he mau haneli o nā API peptide. Ua hoʻopau maikaʻi nā huahana Flagship e like me Semaglutide a me Terlipressin i ka faila US FDA DMF.

ʻO kā mākou ʻoihana paʻa piha, ʻo Hubei JXBio, e hana ana i nā laina hana peptide API i hoʻolālā ʻia e hoʻokō i nā kūlana cGMP i hoʻonohonoho ʻia e ka US FDA a me ka NMPA o Kina. Aia i loko o ka hale he 10 mau laina hana nui a me ka pilot-scale, i kākoʻo ʻia e kahi ʻōnaehana hoʻokele maikaʻi o ka lāʻau lapaʻau (QMS) a me kahi papahana olakino olakino a palekana (EHS).

Ua hala ʻo JXBio i nā mākaʻikaʻi GMP e ka US FDA a me ka NMPA o Kina a ua ʻike ʻia e ke alakaʻi ʻana i nā ʻoihana lāʻau lapaʻau honua no ka maikaʻi o ka hoʻokele EHS, e hōʻike ana i kā mākou kūpaʻa kūpaʻa ʻole i ka maikaʻi, palekana, a me ka mālama ʻana i ke kaiapuni.

Nā ʻāpana ʻoihana kumu

• Hoʻopaʻa inoa honua a me ka hoʻokō hoʻoponopono no nā API peptide

• Nā huahana peptide holoholona a me nā mea hoʻonaninani

• Hoʻomohala a me ka hana ʻana o ka peptide maʻamau (CRO, CMO, OEM)

• Peptide-drug conjugates (PDCs), me:

• Hoʻohui ʻia ʻo Peptide–radionuclide

• Peptide–mau mole liʻiliʻi conjugates

• Hoʻohui ʻia ʻo Peptide-protein

• Nā lāʻau lapaʻau Peptide–RNA

HANA NUI

No ka ʻike hou aku e pili ana i kā mākou huahana, e ʻoluʻolu e kelepona mai iā mākou:

API o ka honua a me nā nīnau hoʻonani: +86-150-1352-9272

Kakau inoa API & Nā lawelawe CDMO (mākeke US a me EU): +86-158-1868-2250

leka uila:jymed@jymedtech.com

Wahi: Papa 8 & 9, Hale 1, Shenzhen Biomedical Innovation Industrial Park,

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