Lati Oṣu Kẹjọ Ọjọ 26 si Oṣu Kẹjọ Ọjọ 30, Ọdun 2024, ile-iṣẹ iṣelọpọ peptide ti JYMed, Hubei JX Bio-Pharmaceutical Co., Ltd., ṣaṣeyọri ṣaṣeyọri ayewo lori aaye ti a ṣe nipasẹ Igbimọ Ounje ati Oògùn AMẸRIKA (FDA). Ayewo naa bo awọn agbegbe pataki gẹgẹbi eto didara, eto iṣelọpọ, ohun elo ati eto ohun elo, awọn iṣakoso yàrá, ati eto iṣakoso awọn ohun elo.
Eyi jẹ ami ayẹwo FDA akọkọ ti pari ni aṣeyọri nipasẹ ile-iṣẹ iṣelọpọ peptide Hubei JX. Gẹgẹbi ijabọ ayewo, didara ohun elo ati awọn eto iṣelọpọ ni kikun pade awọn iṣedede FDA.
JYMed faagun ọpẹ lododo rẹ si alabaṣepọ ilana rẹ, Rochem, fun atilẹyin igbagbogbo wọn lakoko awọn ayewo FDA ti o kọja ati lọwọlọwọ.
Aṣeyọri yii tọka si pe ile-iṣẹ iṣelọpọ peptide ti Hubei JX faramọ awọn ibeere FDA fun didara ati awọn eto iṣelọpọ, ni ẹtọ fun titẹsi si ọja AMẸRIKA.
Nipa JYMed
Ti a da ni ọdun 2009, Shenzhen JYMed Technology Co., Ltd. jẹ ile-iṣẹ imọ-ẹrọ nipa imọ-ẹrọ ti o ṣe amọja ni iwadii ominira, idagbasoke, iṣelọpọ, ati tita awọn ọja peptide, lẹgbẹẹ R&D peptide aṣa ati awọn iṣẹ iṣelọpọ. Ile-iṣẹ nfunni lori awọn API peptide 20, pẹlu awọn ọja marun, pẹlu Semaglutide ati Tirzepatide, ti o ti pari awọn faili US FDA DMF ni ifijišẹ.
Ohun elo Hubei JX ṣe awọn ẹya awọn laini iṣelọpọ 10 fun awọn API peptide (pẹlu awọn laini iwọn-awaoko) ti o ni ibamu pẹlu awọn iṣedede cGMP ti AMẸRIKA, EU, ati China. Ohun elo naa nṣiṣẹ eto iṣakoso didara elegbogi okeerẹ ati eto iṣakoso EHS (Ayika, Ilera, ati Aabo). O ti kọja awọn ayewo GMP osise ti NMPA ati awọn iṣayẹwo EHS ti o ṣe nipasẹ awọn alabara agbaye ti o ṣaju.
Awọn iṣẹ mojuto
1.Abele ati okeere peptide API ìforúkọsílẹ
2.Veterinary ati ohun ikunra peptides
3.Custom peptide synthesis, CRO, CMO, ati awọn iṣẹ OEM
4.PDC (Peptide Drug Conjugates), pẹlu peptide-radionuclide, peptide-kekere moleku, peptide-protein, ati peptide-RNA conjugates
Ibi iwifunni
Adirẹsi: 8th & 9th Floors, Building 1, Shenzhen Biomedical Innovation Industrial Park, Jin Hui Road 14, Kengzi Street, Pingshan District, Shenzhen, China
Fun Awọn ibeere API Kariaye:
+ 86-755-26612112 | + 86-15013529272
Fun Awọn ohun elo Raw Peptide Kosimetik:
+ 86-755-26612112 | + 86-15013529272
Fun Iforukọsilẹ API Abele ati Awọn iṣẹ CDMO:
+ 86-15818682250
Aaye ayelujara:www.jymedtech.com
Akoko ifiweranṣẹ: Oṣu kejila-11-2024