Laipe, JYMed ká peptide gbóògì apo, Hubei Jianxiang Biopharmaceutical Co., Ltd., gba meji osise awọn iwe aṣẹ ti oniṣowo awọn Hubei Provincial Oògùn ipinfunni: awọn "Oògùn GMP Ijẹwọgbigba Iwifunni Ayewo Esi" (No. E GMP 2024-258 ati No. E-GMP 202 si EU) Iwe-ẹri Awọn ohun elo elegbogi (API)” (Iwe-ẹri WC, No. HB240039).

Awọn iwe aṣẹ wọnyi jẹrisi pe laini iṣelọpọ A102 ni Idanileko A102 (fun iṣelọpọ Oxytocin ati Semaglutide APIs) ati laini iṣelọpọ A092 ni Idanileko A092 (fun iṣelọpọ Terlipressin API) ni Hubei Jianxiang pade awọn iṣedede GMP ti China, eyiti o jẹ deede si EU, Ajo Agbaye fun Ilera (WHO GHO).

Ayẹwo naa pari pẹlu ibamu, o nfihan pe iṣakoso didara iṣelọpọ Hubei Jianxiang ati awọn iṣe ilana ni ibamu pẹlu awọn iṣedede giga ti ile. Idagbasoke yii yoo ṣe atilẹyin imugboroja Hubei Jianxiang ni ọja agbaye, ni pataki ni ọja EU, mu igbẹkẹle alabara pọ si, ṣe atilẹyin awọn ifowosowopo kariaye, ati ṣe alabapin si idagbasoke agbaye ati pinpin awọn oogun ti o da lori peptide. Bii ibeere ọja okeere ti n pọ si, Hubei Jianxiang yoo wa ni ipo ti o dara julọ lati pade awọn iwulo ti awọn alabara agbaye pẹlu awọn ọja ati iṣẹ didara ga.

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. Ti ogbo ati ohun ikunra peptides
3. Ṣiṣepọ peptide aṣa, 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:Awọn ipele 8th & 9th, Ilé 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