Hubei JXBio Pharmaceutical Co., Ltd., JYMed ta sadaukar da peptide samar da wurin samar, samu nasarar kammala wani a kan-site dubawa da US Food and Drug Administration (FDA) daga Maris 10-14. Binciken, wani ɓangare na Binciken Tabbatar da Ingancin Magunguna, kimanta mahimman tsarin da suka haɗa da inganci, samarwa, kayan aiki da kayan aiki, sarrafa lab, da sarrafa kayan. APIs da aka bita sun haɗa da Liraglutide, Semaglutide, Tirzepatide, da Oxytocin.

Bayan binciken, FDA ta ba da rahoton Binciken Kafa (EIR), yana mai tabbatar da cewa ayyukan Hubei JXBio sun cika ka'idojin hukumar don inganci da bin ka'ida.

Wannan alama ce ta binciken FDA na biyu a jere da makamanmu na Hubei suka wuce, yana mai tabbatar da sadaukarwarmu ga masana'antu da tsarin inganci. Har ila yau, yana buɗe hanya don yin rajistar samfuran samfuran duniya mai santsi kuma yana ƙarfafa matsayinmu a kasuwar peptide na duniya.

Game da JYMed

JYMed babban kamfani ne na magunguna wanda ya kware a cikin bincike, haɓakawa, samarwa, da kasuwancin samfuran tushen peptide. Hakanan muna ba da sabis na CDMO na ƙarshen-zuwa-ƙarshe, yana ba da ingantattun hanyoyin magance peptide ga magunguna, kayan kwalliya, da abokan cinikin dabbobi a duk duniya.

Fayil ɗin samfurin mu ya haɗa da dozin na peptide APIs. Kayayyakin tuta kamar Semaglutide da Terlipressin sun yi nasarar kammala shigar da FDA DMF ta Amurka.

Reshen mallakarmu gabaɗaya, Hubei JXBio, yana aiki da layin samar da peptide API na yankan-baki wanda aka tsara don saduwa da ka'idodin cGMP waɗanda FDA ta Amurka da NMPA ta China suka saita. Wurin ya haɗa da manyan layukan samarwa masu girma 10 da matukin jirgi, waɗanda ke goyan bayan ingantaccen tsarin kula da ingancin magunguna (QMS) da ingantaccen tsarin kiwon lafiya da aminci na muhalli (EHS).

JXBio ya wuce binciken GMP ta hanyar FDA ta Amurka da NMPA na kasar Sin kuma manyan kamfanonin harhada magunguna na duniya sun amince da su don ƙware a cikin gudanarwar EHS, yana nuna sadaukarwarmu ga inganci, aminci, da kula da muhalli.

Manyan Yankunan Kasuwanci

• Rijistar duniya da bin ka'idoji don APIs peptide

• Magungunan dabbobi da kayan kwalliya na peptide

• Ci gaban peptide na al'ada da masana'antu (CRO, CMO, OEM)

• Peptide-drug conjugates (PDCs), gami da:

• Peptide-radionuclide conjugates

• Peptide-kananan ƙwayoyin ƙwayoyin cuta

• Peptide-protein conjugates

• Magungunan Peptide-RNA

BABBAN KAYANA

Don ƙarin bayani game da samfuranmu, da fatan za a tuntuɓe mu:

API ɗin Duniya da Tambayoyin Kayan Kayan Aiki: +86-150-1352-9272

API ɗin Rajista & Sabis na CDMO (kasuwannin Amurka da EU): +86-158-1868-2250

Imel:jymed@jymedtech.com

Adireshin: benaye 8 & 9, Ginin 1, Shenzhen Biomedical Innovation Industrial Park,

14 Hanyar Jinhui, gundumar Kengzi, gundumar Pingshan, Shenzhen, China