GMP Drug Product Manufacturing Facilities：

Formulation CMO: Tablets, hard capsules, granules, powders, cream, ointment and gel；

Including anti-tumor drugs (OEB3/4) production facility.

GMP facilities ~13000 square meters

• 7 independent Class D manufacturing areas
• Oral solid dosages:
  • 4 areas, annual capacity: ~1 billion units
• Semisolid topical dosages:
  • 2 area, annual capacity: ~ 40 million tubes
• Solid dispersion: 1 area
• GMP Warehouses of various storage conditions including cold storage.

• Passed 2 joint State and Provincial NMPA on-site PAI and GMP inspections supporting NDA by MAH (Dec. 2021 and May 2022)
• Passed ＞75 customer GMP audits (2019~2022), including Chinese, US and EU customers.
• Passed 2 EU 3rd party QP remote GMP audit for clinical sample manufacturing. (Mar. 2021 and Oct. 2022)

cGMP Manufacturing Services for Drug Products:

Formulation scale up and registration batch production

Clinical sample preparations

Commercial drug product manufacturing for MAH

Analysis method transfer and validation

Micronization, pellets and solid dispersions

Spray drying; fluidized bed; lyophilization; hot-melt extrusion

Stability Study

Characteristics of semi-solid preparations for external use

General oral and targeted anti-tumor solid preparation facilities

Dosage forms: tablets, hard capsules, granules, powders, cream, ointment and gel