Utshintsho lweeyeza e-Changshan
Imida yeeMveliso ze-API
Kukho indibano yocweyo ezinikezelweyo yeHeparin API, iEnoxaparin Sodium API kunye neDalteparin Sodium neNadroparin Calcium API. Ezi ndibano zintathu zonke zisanda kwenziwa kwaye zinezixhobo zazo ezinikezelweyo zemveliso, inkqubo ye-HVAC nokucoca inkqubo yamanzi.
| Amandla e-APIs oNyaka | |||
|---|---|---|---|
| IHeparin Sodium API: Isigidi ezi-5 mega DMF No: 24595 | |||
| I-Enoxaparin Sodium API: 5,000kg DMF No: 26258 | |||
| I-Dalteparin Sodium API: 3,000 kg DMF No: 29154 | |||
| I-API yaseNadroparin yeCalcium: 3,000 kg | |||
| I-Hyaluronic Sodium API: 21,000 kg |
F5 B + S Umgca wokugcwalisa kweSirinji
Umatshini wokugcwalisa isirinji waseJamani B + S:
Itekhnoloji ye-servo epheleleyo, uyilo olungasetyenziswanga, kunye nokudityaniswa neSwitzerland SKAN iseptic eyodwa yokufikelela kwinqanaba eliphezulu leemeko ze-aseptic zemveliso ezenzekelayo, kwaye idibane ngokupheleleyo ne-FDA kunye nemigangatho ye-GMP yaseYurophu.
I-Switzerland SKAN:
Isolator, ukwahlula izixhobo zokwenza imveliso ngokupheleleyo kubume bendibano ukulungiselela ukufezekisa imeko-bume efanelekileyo. Ukwahlula imveliso kunye nomsebenzi. Imveliso ikhuseleke, kwaye umsebenzi ukhululeke.
| Imigca yemveliso | Umthamo / unyaka (Million) | Inombolo yebatch | Ixesha lokuvelisa iBatch (h) |
|---|---|---|---|
| F1, umgca wokugqibela westerilization-ampoule | 30 | 250 | ≤ 8 |
| F2, Aseptic -omphambili umgca | 30 | 250 | ≤ 8 |
| F3, umgca we-Aseptic -vial | 25 | 250 | ≤ 8 |
| F4, umgca-Aseptic -PFS | 40 | 250 | ≤ 8 |
| F5, umgca-Aseptic -PFS umgca (ukwakhiwa) | 60 | 250 | ≤ 8 |
| Ii-FDF's's Capacity | |||
|---|---|---|---|
| IHeparin Sodium Injection (i-vials): izigidi ezingama-20 | |||
| IHeparin Sodium Injection (ampoul): izigidi ezingama-80 | |||
| I-LMWH Injection (PFS): i-40 yezigidi |
Ulwakhiwo luqale ngoJulayi ngo-2015, ekuZhengding kwisithili semizi-mveliso ephezulu, egubungela indawo engqonge i-198,000㎡, kubandakanya ne-66,700㎡ yeprojekthi ye-heparin.
Ukucwangciswa rhoqo ngonyaka nge-7 500,000 ye-intestine mucosa ye-mucosa, i-3,000,000 ye-intestine elungiselelwe, kunye ne-500000 mega ye-heparin e-crude, kwaye kuya kubakho iprojekthi II enokunceda ukuphinda kabini ubuninzi bokuvelisa.
Isiseko esingalunganga
