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