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CMC/CMO Service Platform


 Injections


Small-volume injections ,freeze-dried powder for injection (anti-tumor / non-terminally sterilized)

Submitted for the US FDA inspection (Certification code: 213768#)

Batch size: 5 L - 400 L

Size and capacity (vial): 30 million per year for 2 mL / 7 mL / 10 mL, 16 million per year for 15 mL / 20 mL, and 10 million per year for 30 mL / 50 mL

 

Small-volume injections ( vial、ampoule terminally sterilized)

 EU EMA certification passed

Batch size: 8 L - 800 L

Size(vial): 2 mL, 7 mL, 10 mL, 15 mL and 20 mL

Size(ampoule) : 1 mL, 2 mL, 5 mL, 10 mL and 20 mL

Capacity: 50 million per year

 

Small-volume injections, common freeze-dried powder for injection (non-terminally sterilized)

Batch size: 10 L - 900 L

Size(vial): 2 mL, 7 mL, 10 mL, 15 mL and 20 mL

Capacity: 50 million per year

 

Cartridge, prefill syringe and small-volume injection (non-terminally sterilized)

Batch size: 8 L - 300 L

Size: 3 ml cell cartridge

Capacity: 20 million per year

 

Liposome, microemulsion, fat emulsion (terminally sterilized)

Batch size: 150 L - 250 L

Size (vial): 2 mL, 7 mL, 10 mL, 15 mL and 20 mL

Size (ampoule): 1 mL, 2 mL, 5 mL, 10 mL and 20 mL

Capacity: 50 million per year

 

Blow-fill-seal (BFS/plastic ampoule/terminally sterilized)

Size: 5 mL, 10 mL

Capacity: 10 million per year


Large-volume infusion (terminally sterilized/glass container)

Batch size: 2000 L - 6000 L

Size: 100 mL, 250 mL

Capacity: 18 million per year


 

Oral solid dosage forms


Lyophilized orally disintegrating tablets

      Covering fill volume: 0.1 mL - 0.6 mL: 0.1ml~0.6ml

     Batch size: 5 k – 100 k tablets

     Capacity: 200 million per year

 

Tablets, hard capsules, soft capsules, granules and powder

    Batch size: 5 kg - 400 kg

    Capacity: 3 trillion(tablet/pill)per year


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