Daga 26 ga Agusta zuwa 30 ga Agusta, 2024, wurin samar da peptide na JYMed, Hubei JX Bio-Pharmaceutical Co., Ltd., ya yi nasarar shawo kan wani binciken da Hukumar Abinci da Magunguna ta Amurka (FDA) ta gudanar. Binciken ya ƙunshi mahimman wurare kamar tsarin inganci, tsarin samarwa, kayan aiki da tsarin kayan aiki, kula da dakin gwaje-gwaje, da tsarin sarrafa kayan.
Wannan alama ce binciken farko na FDA wanda cibiyar samar da peptide ta Hubei JX ta kammala. Dangane da rahoton dubawa, ingancin kayan aikin da tsarin samarwa sun cika ka'idojin FDA.
JYMed tana mika godiya ta gaske ga abokin aikinta na dabaru, Rochem, saboda ci gaba da goyan bayansu a lokacin binciken FDA na baya da na yanzu.
Wannan nasarar tana nuna cewa cibiyar samar da peptide ta Hubei JX tana bin ka'idodin FDA don inganci da tsarin samarwa, wanda ya cancanci shiga kasuwar Amurka.
Game da JYMed
An kafa shi a cikin 2009, Shenzhen JYMed Technology Co., Ltd. kamfani ne na ilimin halittu wanda ya ƙware a cikin bincike mai zaman kansa, haɓakawa, samarwa, da tallace-tallace na samfuran peptide, tare da peptide R&D na al'ada da sabis na masana'antu. Kamfanin yana ba da fiye da 20 peptide APIs, tare da samfurori guda biyar, ciki har da Semaglutide da Tirzepatide, bayan nasarar kammala US FDA DMF filings.
Wurin Hubei JX yana fasalta layukan samarwa 10 don peptide APIs (ciki har da layukan sikelin matukin jirgi) waɗanda ke bin ka'idodin cGMP na Amurka, EU, da China. Wurin yana aiki da cikakken tsarin kula da ingancin magunguna da tsarin gudanarwa na EHS (Muhalli, Lafiya, da Tsaro). Ya wuce binciken GMP na hukuma na NMPA da binciken EHS wanda manyan abokan cinikin duniya ke gudanarwa.
Core Services
1.Domestic da na kasa da kasa peptide API rajista
2.Veterinary da na kwaskwarima peptides
3.Custom peptide kira, CRO, CMO, da sabis na OEM
4.PDC (Peptide Drug Conjugates), ciki har da peptide-radionuclide, peptide-kananan kwayoyin halitta, peptide-protein, da kuma peptide-RNA conjugates.
Bayanin hulda
Adireshi: 8th & 9th bene, Ginin 1, Shenzhen Biomedical Innovation Industrial Park, Jin Hui Road 14, Kengzi Street, Pingshan District, Shenzhen, China
Don Tambayoyin API na Ƙasashen Duniya:
+86-755-26612112 | + 86-15013529272
Don Kayan Kayan Kayan Kayan Kayan Gida na Peptide Raw:
+86-755-26612112 | + 86-15013529272
Don Rijistar API na Gida da Ayyukan CDMO:
+ 86-15818682250
Yanar Gizo:www.jymedtech.com
Lokacin aikawa: Dec-11-2024