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

            SVPs, freeze-dried powder for injection (oncology drugs / aseptic processing line)

Passed the US FDA inspection (Certification code: 213768#)

Batch size: 5 L - 400 L

Annual capacity: 30 million units per year for 2 mL / 7 mL / 10 mL vials, 16 million units per year for 15 mL / 20 mL vials, and 10 million units per year for 30 mL / 50 mL vials

                   SVPs, freeze-dried powder for injection (conventional drugs / aseptic processing line)

Batch size: 15 L - 900 L

Vial size: 2 mL, 7 mL, 10 mL, 15 mL and 20 mL

Annual capacity: 50 million vials per year

SVPs ( vial, ampoule / terminal sterilization lines)

Obtained the EU EMA certification

Batch size: 8 L - 800 L

Vial size: 2 mL, 7 mL, 10 mL, 20 mL and 50 mL

Ampoule size: 1 mL, 2 mL, 5 mL, 10 mL and 20 mL

Annual capacity: 50 million units per year

Cartridge and pre-filled syringe of SVPs (terminal sterilization lines)

Batch size: 8 L - 300 L

Cartridge size: 1.8 mL and 3 mL

PFS size: 1 mL and 3 mL

Annual capacity: 5 million units per year

Liposome, Microemulsion, fat emulsion (terminal sterilization line)

Batch size: 150 L - 250 L

Vial size: 2 mL, 7 mL, 10 mL, 20 mL and 50 mL

Ampoule size: 1 mL, 2 mL, 5 mL, 10 mL and 20 mL

Annual capacity: 50 million units per year

Blow-fill-seal (BFS)

Size: 5 mL, 10 mL，20ml

Annual capacity: 10 million units 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

Annual capacity: 200 million units per year

Tablets, hard capsules, soft capsules, granules and powders

Batch size: 5 kg - 400 kg

Annual capacity: 3 trillion units per year