CMC/CMO Service Platform

Services

²  R&D technology transfer and pilot-scale manufacturing

²  CMO for commercial manufacturing

²  Clinical sample preparation

²  Stability study

²  Registration batch, process validation, batch production

²  MAH product industrialization

Injections

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

Passed US FDA certification (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, freeze-dried powder for injection (non-anti-tumor / non-terminally sterilized)

Batch size: 15 L - 900 L

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

Capacity: 50 million vials per year

Small-volume injections ( vial, ampoule / terminally sterilized)

Passed EU EMA certification

Batch size: 8 L - 800 L

Size (vial): 2 mL, 7 mL, 10 mL,  20 mL and 50 mL

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

Capacity: 50 million per year

Cartridge and pre-filled syringe of small-volume injection (terminally sterilized)

Batch size: 8 L - 300 L

Size: 1.8 mL and 3 mL cartridges

Size: 1 mL and 3 mL pre-filled

Capacity: 5 million per year

Liposome, Micro emulsion, fat emulsion (terminally sterilized)

Batch size: 150 L - 250 L

Size (vial): 2 mL, 7 mL, 10 mL, 20 mL and 50 mL

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

Capacity: 50 million per year

Blow-fill-seal (BFS)

Size: 5 mL, 10 mL，20ml

Capacity: 10 million per year

Oral solid dosage forms

Lyophilized orally disintegrating tablets

Fill volume: 0.1 mL - 0.6 mL (Alu-Alu), 0.1 mL – 1.2 mL (PVC)

Batch size: 5 k – 400 k tablets

Capacity: 200 million per year

Tablets, hard capsules, soft capsules, granules and powder

Batch size: 5 kg - 400 kg

Capacity: 3 trillion (tablets/pills) per year