We are operating in a brand new facility, which allows HNSP to be one of the leading companies into the CGMP manufacture of bioactive peptides.
CGMP Production Facility
Our modern facility offers 5,700 square meters (613,542+ square feet) of production area and laboratories, for the CGMP manufacture of Sterile API Peptides, including lyophilization and packaging under sterile conditions. Six facilities have passed the CFDA CGMP audit (including two Peptide API facilities and four Lyophilized Injection facilties); Non-sterile API manufacturing facility received US FDA approval in 2013; Italian authority AIFA will inspect Thymalfasin API and FD in Jan/Feb 2016; US FDA may inspect Bivalirudin API and FD in 2016. Also, HNSP’s new production line for Cartridge formulations is ready for production.