Mankhwala a Changshan
Ma API 'Production Mafuta
Pali malo odzipereka opanga Heparin API, Enoxaparin Sodium API ndi Dalteparin Sodium & Nadroparin Calcium API. Zochita zitatuzi zonse zangokhazikitsidwa kumene ndipo ali ndi zida zawo zopangidwira, HVAC dongosolo ndikuyeretsa madzi.
| Kukula Kwa API Kwa pachaka | |||
|---|---|---|---|
| Heparin Sodium API: 5 miliyoni mega DMF No: 24595 | |||
| Enoxaparin Sodium API: 5,000kg DMF No: 26258 | |||
| Dalteparin Sodium API: 3,000 kg DMF No: 29154 | |||
| Nadroparin Calcium API: 3,000 kg | |||
| Hyaluronic Sodium API: 21,000 kg |
F5 B + S Chingwe Chodzaza
Makina achijeremani a B + S omwe amadzazitsa isirikali:
Ukadaulo wathunthu wa servo, kapangidwe kaulere, ndi kuphatikiza ndi Swiss SKAN aseptic kudzipatula kuti akwaniritse milingo yayitali kwambiri ya aseptic yopanga automated, ndikukumana kwathunthu ndi FDA ndi European GMP miyezo.
Switzerland SKAN:
Isolator, kupatula zida zopangira kwathunthu kuchokera kumalo azokambirana kuti mukwaniritse bwino malo opangira. Kupatula malonda ndi wogwira ntchito. Malonda akhale otetezeka, ndipo wogwira ntchito akhale omasuka.
| Mizere yazogulitsa | Kutha / chaka (Miliyoni) | Nambala yolumikizira | Nthawi yopanga ma Batch (h) |
|---|---|---|---|
| F1, Chingwe chogwirizira-chimalizidwe | 30 | 250 | ≤ 8 |
| F2, mzere wa Aseptic -ampoule | 30 | 250 | ≤ 8 |
| F3, mzere wa Aseptic -vial | 25 | 250 | ≤ 8 |
| F4, mzere wa Aseptic -PFS | 40 | 250 | ≤ 8 |
| F5, Aseptic -PFS mzere (kumanga) | 60 | 250 | ≤ 8 |
| Kukwanitsa Kwa FDFs Pachaka | |||
|---|---|---|---|
| Heparin Sodium Injection (Mbale): 20 miliyoni | |||
| Heparin Sodium Injection (ampoul): 80 miliyoni | |||
| LMWH Injection (PFS): 40 miliyoni |
Ntchito yomanga idayamba mu Julayi 2015, ku Zhengding m'boma lamakono lotsogola, malo pafupifupi 198,000㎡, kuphatikiza 66,700㎡ pulojekiti yakuda ya heparin.
Pachaka amagwiritsa ntchito 7,500,000 ya intestine mucosa, 3,000,000 yamatumbo okonzedwa, ndikuzungulira 500,000 mega wa heparin, ndipo pakhala polojekiti II yomwe ingathandizire kuwonjeza kuchuluka pamwambapa.
Crude Base
