Muva nje, indawo yokukhiqiza i-jymed's Peptide, Hubei Jiantiang Biopharmaceutical Co, Ltd, uthole amadokhumenti amabili asemthethweni akhishwe yiHubei Provincial Drug Administration: "Isaziso sokulandela izidakamizwa" (Cha. E GMP 2024-258 no-No. E GMP 20 2024-260) kanye "Thumela Ukuthekelisa Kwisitifiketi Sokusebenza Kwemithi (API)" (Isitifiketi se-WC, Cha. HB240039).

Le mibhalo iqinisekisa ukuthi umugqa wokukhiqiza we-A102 eWorkshop A102 (ngokukhiqizwa kwe-OxeTocin neSemaglutide API) kanye nomugqa wokukhiqiza we-A092 eWorkeinin API) eHubei jianxiang ahlangana ne-China GMP izindinganiso, ezilingana ne I-EU, inhlangano yezempilo yomhlaba (WHO), kanye nezidingo ze-ICH Q7 GMP yezemithi.

Ukuhlolwa kwaphetha ngokuhambisana, okubonisa ukuthi ukuphathwa kwekhwalithi ye-Hubeiniag's Construence kanye nemikhuba yokulawula kuhlangana namazinga aphezulu asekhaya. Le ntuthuko izokweseka ukunwetshwa kukaHubexi jianxiang emakethe yomhlaba, ikakhulukazi emakethe ye-EU, ithuthukise ukwethenjwa kwamakhasimende, ukusebenzisana kwamakhasimende, futhi kufaka isandla ekukhuleni kwezidakamizwa emhlabeni jikelele. Njengoba ukufunwa kwamamakethe kwamanye amazwe kukhuphuka, iHubei jianxiang izokwenziwa ngcono ukuze ihlangabezane nezidingo zamakhasimende omhlaba anemikhiqizo esezingeni eliphakeme nezinsizakalo.

Mayelana noJymed

Yasungulwa ngonyaka ka-2009, iShenzhen Jment Technology Co, Ltd. iyinkampani ye-biotechnology egxile ocwaningweni oluzimele, ukuthuthukiswa, ukukhiqizwa kanye nokuthengiswa kwemikhiqizo ye-peptide, kanye nezinsizakalo zokukhiqiza. Le nkampani inikezela ngama-apis ama-peptide angaphezu kwama-20, anemikhiqizo emihlanu, kufaka phakathi i-semaglutide ne-tirezepatide, ekuqedeni ngempumelelo ukugcwaliswa kwe-FDA DMF.

I-Hubei JX Facility ifaka imigqa engu-10 yokukhiqiza ama-peptide APIs (kufaka phakathi imigqa yezindiza yezindiza) ehambisana namazinga we-CGMP we-US, eU, neChina. Lesi sikhungo sisebenza uhlelo lokuphathwa kwekhwalithi oluphelele lwekhwalithi kanye ne-EHS (Ezemvelo, Ezempilo, kanye nezokuphepha). Idlulise ukuhlolwa kwe-NMPA GMP esemthethweni kanye nokucwaningwa kwamabhuku kwe-EHS okwenziwe ngamakhasimende omhlaba aholayo.

Izinsizakalo Eziyisisekelo

1. Ukubhaliswa kwe-API yasekhaya nasekhaya
2. Ama-peptides wezilwane kanye nezimonyo
3. Ukuhlanganiswa okwenziwe ngokwezifiso kwe-peptide, Cro, CMO, kanye nezinsizakalo ze-OEM
4. I-PDC (izimboni zezidakamizwa ze-peptide), kufaka phakathi i-peptide-radionuclide, i-peptide-molecuclide, i-molecule encane, amaprotheni ama-peptin, kanye nama-peptide-rna ahlangana

Ulwazi lokuxhumana

Ikheli:Izitezi ze-8 & 9th, Isakhiwo 1, Shenzhen Biomedical Innovation Industrial Park, Jin Hui Road 14, Kengzi Street, Pingzhen, China

Kwimibuzo ye-API yamazwe omhlaba:
+ 86-755-266121112 | + 86-15013529272

Okwezinto ezifuywayo ezifuywayo ezifuywayo ezifuywayo:
+ 86-755-266121112 | + 86-15013529272

Ngokubhaliswa kwasekhaya kwe-API kanye nezinsizakalo ze-CDMO:
+ 86-15818682250

Iwebhusayithi: www.Jymedtech.com