Production
Capacity
GMP
Regulatory
R&D
(process optimization- scale up
production)
EHS
Based on our excellent GMP, EHS and regulatory registration system in line with international standards, building up a CMO platform with integrate advantageous resources and achieves a good and high-effective system integrating R&D, compliant production and registration.
◆ Laboratory process transfer and process optimization
◆ Provide pilot scale-up / process validation / GMP
commercial production
◆ CMO product stability study / quality research support
◆ Domestic / foreign registration documents preparation
◆ Acceptable for domestic / foreign authority’s and
customer’s audit
◆ CMO projects for products with OEB class 1/2/3
Coordinated development of CMO/ CDMO projects with
our existing API business
Integrate R & D resources, expand CMO / CDMO business, make use of the accumulated ability to develop high-purity products for many years, provide solutions for low-cost with high-quality products, and actively carry out more project cooperation with originators and top generic companies.