I-Changshan Pharmaceutical
Imigqa yokukhiqiza yama-API
Kukhona umhlangano wokukhiqiza ozinikele ngokulandelana we-Heparin API, i-Enoxaparin Sodium API ne-Dalteparin Sodium neNadroparin Calcium API. Lezi zindawo zokusebenzela ezintathu zonke zisanda kusungulwa futhi zinempahla yazo yokusebenza ekhethekile ezinikezele, uhlelo lwe-HVAC futhi luhlanze uhlelo lwamanzi.
| Amandla Wonyaka we-APIs | |||
|---|---|---|---|
| IHeparin Sodium API: izigidi ezi-5 mega DMF No: 24595 | |||
| Enoxaparin Sodium API: 5,000kg DMF No .: 26258 | |||
| I-Dalteparin Sodium API: 3,000 kg DMF No: 29154 | |||
| I-Nadroparin Calcium API: 3,000 kg | |||
| I-Hyaluronic Sodium API: 21,000 kg |
F5 B + S Syringe Ukugcwalisa Line
Umshini wokugcwalisa isirinji waseGerman B + S
Ubuchwepheshe obugcwele be-servo, ukwakhiwa okungahambi kahle, kanye nokuhlanganiswa kweSwitzerland SKAN eseterator eyedwa ukufeza izinga eliphakeme kakhulu lezimo ze-aseptic zokukhiqizwa okuzenzakalelayo, futhi ihlangabezane ngokuphelele ne-FDA kanye namazinga we-GMP ase-Europe.
ISwitzerland SKAN:
Isolator, ukwahlukanisa imishini yokukhiqiza ngokuphelele kusuka kumvelo yokusebenzela ukuze uzuze imvelo enhle kakhulu yokukhiqiza. Ukwehlukanisa umkhiqizo kanye nomsebenzi. Vumela umkhiqizo uphephe, futhi isisebenzi sikhululeke.
| Imigqa yomkhiqizo | Amandla / unyaka (Million) | Inombolo ye-Batch | Isikhathi sokukhiqizwa kwe-Batch (h) |
|---|---|---|---|
| F1, umugqa weSterilization-ampoule line | 30 | 250 | ≤ 8 |
| F2, umugqa we-Aseptic -ampoule | 30 | 250 | ≤ 8 |
| F3, umugqa we-Aseptic -vial | 25 | 250 | ≤ 8 |
| F4, umugqa we-Aseptic -PFS | 40 | 250 | ≤ 8 |
| F5, umugqa we-Aseptic -PFS (okwakha) | 60 | 250 | ≤ 8 |
| Amandla Wonyaka we-FDFs | |||
|---|---|---|---|
| IHeparin Sodium Injection (izimpo): izigidi ezingama-20 | |||
| IHeparin Sodium Injection (ampoul): izigidi ezingama-80 | |||
| I-LMWH Injection (PFS): izigidi ezingama-40 |
Ukwakha kwaqala ngoJulayi 2015, esifundeni sezimboni saseZhengding esisezingeni eliphezulu, okuhlanganisa indawo engaba ngu-198,000㎡, kufaka phakathi i-66 700㎡ yephrojekthi ye-heparin engahlanzekile.
Ukucutshungulwa minyaka yonke okungama-7 500,000 we-procine amathumbu mucosa, ama-3,000,000 wamathumbu alungiselelwe, kanye nama-500,000 mega we-heparin engahlanzekile, futhi kuzoba nephrojekthi II engasiza ukuphinda inani lokukhiqiza elingehla.
Isizinda Esingahluzeki
