in shenzhen, chengdu, linyi of china, and wisconsin, iowa, and oklahoma in the u.s., hepalink has multiple modern manufacturing sites and dozens of state-of-art large production lines built with equipment that are compliant with the gmp standard of respective countries. the company’s manufacturing processes are highly automated, are therefore able to reliably produce high quality products. in addition, the company also provides high-value cdmo services in product development and manufacturing.
manufacturing site for finished dose products, nanshan district, shenzhenthis site houses hepalink’s group hq and the duopule site – techdow’s facility for the production of enoxaparin preparations. with a floor area of 32,980 square meters, this site is dedicated to the manufacturing of heparin apis, enoxaparin apis, enoxaparin preparations and standard heparin preparations. the site is equipped with the contract manufacturing capability for syringe preparations and penicillin bottle preparations. the site has passed numerous gmp inspections by multiple countries, and hepalink's heparin api and enoxaparin api lines received seven clean bills of health from on-site inspections by the u.s. fda.
pingshan industrial park, shenzhenthis site has a floor area of over 400,000 square meters and was designed in compliance with the cgmp standards of the u.s., eu, and china. the site is already manufacturing heparin apis, and will be purposed as the main site for the r&d and manufacturing of heparin products and innovative drugs.
spl site, wisconsin, united stateswith a land area of 8,852 square meters and built in compliance with the u.s. cgmp standard, this site has passed multiple on-site inspections by the u.s. fda. the site is dedicated to the manufacturing of heparin apis, pancreatin apis, and animal derived products.
cytovance site, united stateslocated in oklahoma city with a floor area of 8,454 square meters, this site commenced operations in 1992 and has since received a total investment of over us$ 200 million. the site has a manufacturing capacity of 4,000 liters of mammalian cell culture and 1,500 liters of fermented microbials. this site has passed multiple on-site inspections by the fda, and is currently providing cdmo services in innovative large molecule biologics including antibodies, vaccines, cell and gene therapies.