Mofuta oa limela oa Changshan
Li-Production tsa API tsa APIs
Ho na le pokello ea tlhahiso e inehetseng e sebelisoang bakeng sa Heparin API, Enoxaparin Sodium API le Dalteparin Sodium & Nadroparin Calcium API. Lithupelo tsena tse tharo kaofela li sa tsoa thehoa 'me li na le lisebelisoa tsa tsona tsa tlhahiso tse ikhethileng, Sisteme ea HVAC le tlhoekiso ea metsi.
| Bokhoni ba selemo le selemo ba APIs | |||
|---|---|---|---|
| Heparin Sodium API: Mega DMF No limilione tse 5: 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 Syringe Filling Line
Mochini oa Jeremane oa B + S oa pele o tlatsang syringe:
Theknoloji ea servo e felletseng, moralo o sa lokiseng, le ho hokahana le Swiss SKAN aseptic exclider ho fihlela boemo bo holimo haholo ba aseptic maemo a tlhahiso, o kopane ka botlalo le litekanyetso tsa FDA le European GMP.
Switzerland SKAN:
Isolator, ho arola lisebelisoa tsa tlhahiso ka botlalo ho tloha tikolohong ea seboka e le ho fihlela tikoloho e ntlehali ea tlhahiso. Ho arola sehlahisoa le mosebetsi. Lihlahisoa li bolokehe, 'me mosebeletsi a phutholohe.
| Lithane tsa sehlahisoa | Bokhoni / selemo (Milione) | Batch nomoro | Nako ea tlhahiso ea Batch (h) |
|---|---|---|---|
| F1, Lineine Sterilization-ampoule mohala | 30 | 250 | ≤ 8 |
| F2, mohala oa li-aseptic -ampoule | 30 | 250 | ≤ 8 |
| F3, mola oa Aseptic -vial | 25 | 250 | ≤ 8 |
| F4, mohala oa Aseptic -PFS | 40 | 250 | ≤ 8 |
| F5, mohala oa Aseptic -PFS (oa kaho) | 60 | 250 | ≤ 8 |
| Bokhoni ba selemo le selemo ba li-FDF | |||
|---|---|---|---|
| Heparin Sodium Injection (vials): limilione tse 20 | |||
| Heparin Sodium Injection (ampoul): limilione tse 80 | |||
| LMWH Injection (PFS): limilione tse 40 |
Kaho e qalile ka Phupu 2015, e setereke sa mahlale se phahameng sa Zhengding, se koahelang sebaka sa hoo e ka bang 198,000㎡, ho kenyelletsoa le 66 700㎡ bakeng sa morero oa heparin.
Selemo le selemo ho sebetsoa lipalo tse 7 500,000 tsa "intestine mucosa" tse likete tse 3,000,000 tse hlophisitsoeng, le li-mega tse 500 tsa "heparin" e seng e sa sebetse, 'me ho tla ba le projeke ea II e ka thusang ho eketsa habeli tlhahiso e kaholimo.
Crude Base
