Huringa Takahuri
Raina 'Whakapaahanga a APIs
He awheawhe whakaputa i whakatapua mo ia API Heparin, API Enoxaparin Sodium me Dalteparin Sodium & Nadroparin Calcium API. Ko enei awheawhe e toru kei te hou katoa, me a raatau ake waahanga whakatipu whakatapua, nga punaha HVAC me te horoi i te punaha wai.
| Te Kaha Motuhake a APIs | |||
|---|---|---|---|
| Heparin Sodium API: 5 miriona 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 |
Raina F5 B + S Raring Whakakii
Tiamana B + S miihini whakakii whakakiiu paraikete:
Ko te hangarau servo tonu, te hoahoa koreutu-tiaki, me te whakauru ki te wehe a te SKAN aseptic Switzerland hei whakatutuki i te taumata tiketike o nga tikanga o te hanga miihini, me te whakatutuki pai i te FDA me nga paerewa GMP Pakeha.
Switzerland SKAN:
Isolator, ki te wehe i nga taputapu hanga mai i te waahi awheawhi kia pai ai te taiao whakaputa pai. Hei wehe i te hua me te kaimahi. Kia haumaru te hua, kia tau hoki nga kaimahi.
| Raina hua | Te Aitanga / Tau (Miriona) | Tau Paki | Te wa whakahiu (h) |
|---|---|---|---|
| F1, Te Raarangi Whakamutunga-Tere-whakarahi | 30 | 250 | ≤ 8 |
| F2, Raina Aseptic -piko | 30 | 250 | ≤ 8 |
| F3, Raina Aseptic -vial | 25 | 250 | ≤ 8 |
| F4, Raina Aseptic -PFS | 40 | 250 | ≤ 8 |
| F5, Raarangi Aseptic -PFS (hanga) | 60 | 250 | ≤ 8 |
| Te Kaha Awhina FDFs | |||
|---|---|---|---|
| Heparin Sodium Injection (pouaka): 20 miriona | |||
| Heparin Sodium Injection (ampoul): 80 miriona | |||
| LMWH Injection (PFS): 40 miriona |
I timata te hanganga i te Hūrae 2015, kei Zhengding i te rohe hangarau hangarau nui, e kapi ana i te rohe o te 198,000㎡, tae atu ki te 66,700㎡ mo te kaupapa heparin.
Ko te tukatuka o ia tau 7,500,000 o te mucosa whiwi o te kopu ， 3,000,000 o te kopu rite, me te 500000 mega o te heparin parakore, a tera ano he kaupapa II ka taea te awhina ki te whakakapo i te rahinga whakaputa i runga ake nei.
Pokapu Kore
