Changshan Tshuaj
APIs 'Cov Kab Ntau Lawm
Muaj yog kev cob qhia ntau lawm ua feem rau Heparin API, Enoxaparin Sodium API thiab Dalteparin Sodium & Nadroparin Calcium API. Peb lub rooj cob qhia no tau tsim txhua lub tshiab thiab muaj lawv cov khoom siv tshwj xeeb muaj txiaj ntsig, HVAC system thiab lim dej huv zog.
| APIs 'Peev Xwm Txhua Xyoo | |||
|---|---|---|---|
| Heparin Sodium API: 5 lab 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 Koob txhaj Sau Kab
German B + S pre-filling syringe filling tshuab:
Puv servo thev naus laus zis, kev tsim kho tsis pub dawb, thiab kev sib koom ua ke nrog Swiss SKAN aseptic isolator kom ua tiav qib siab ntawm kev ua kom tsis sib luag ntawm cov tshuab tsis zoo, thiab ua tau raws li FDA thiab European GMP cov qauv.
Switzerland SKAN:
Isolator, kom cais cov khoom siv ntau lawm los ntawm cov chaw ua haujlwm Rhiav kom ua tiav qhov chaw zoo tshaj plaws. Txhawm rau cais cov khoom thiab tus neeg ua haujlwm. Cia cov khoom lag luam zoo, thiab cov neeg ua haujlwm nyiam.
| Khoom kab | Peevxwm / xyoo (Lab) | Batch tooj | Siv sijhawm ntau lawm (h) |
|---|---|---|---|
| F1, Lub Chaw Nres Tsheb kom tshem tawm cov kab-ampoule kab | 30 | 250 | ≤ 8 |
| F2, Aseptic-yob kab | 30 | 250 | ≤ 8 |
| F3, Aseptic-suab kab | 25 | 250 | ≤ 8 |
| F4, Aseptic -PFS kab | 40 | 250 | ≤ 8 |
| F5, Aseptic -PFS kab (tsim qauv) | 60 | 250 | ≤ 8 |
| FDFs Qhov Peev Xwm Txhua Xyoo | |||
|---|---|---|---|
| Heparin Sodium Txhaj (vials): 20 lab | |||
| Heparin Sodium Txhaj (ampoul): 80 lab | |||
| LMWH Txhaj Tshuaj (PFS): 40 lab |
Kev tsim kho pib thaum Lub Xya Hli 2015, nyob hauv Zhengding high-tech industrial cheeb tsam, suav txog thaj tsam thaj tsam ntawm 198,000㎡, suav nrog 66,700㎡ rau qhov dej num heparin.
Kev tsim tawm txhua xyoo 7,500,000 ntawm lub tsev muaj qhov quav plab hnyuv mucosa ， 3,000,000 ntawm txoj hnyuv npaj, thiab ib ncig 500000 mega ntawm heparin nyoos, thiab yuav muaj ib qhov project II uas tuaj yeem pab ua ob npaug ntawm cov khoom lag luam saum toj no.
Looj Loog
