07.24.19
STA Pharmaceutical Co.’s (WuXi STA) Analytical Service Unit in Shanghai and active pharmaceutical ingredient (API) process R&D and manufacturing facility in Changzhou, have successfully passed two inspections from the U.S. FDA, with no Form 483s issued.
WuXi STA has now successfully passed seven inspections from the U.S. FDA since 2013, producing branded drugs marketed in 95 countries. Its Analytical Service Unit provides analytical method development, validation and testing services from preclinical to commercial. The Changzhou facility offers technology platforms such as spray dried dispersion, continuous processing (flow chemistry), oligonucleotides and peptides. It successfully completed the first U.S. FDA inspection in 2018.
"WuXi STA takes high priority on building quality system meeting global regulatory standards. These successful FDA inspections to ASU and Changzhou facility reflects WuXi STA's commitment to 'quality first'. We will continue to enhance our platform with highest quality service to better enable our customers to bring better medicines faster for patients." added Dr. Minzhang Chen, CEO of WuXi STA.
WuXi STA has now successfully passed seven inspections from the U.S. FDA since 2013, producing branded drugs marketed in 95 countries. Its Analytical Service Unit provides analytical method development, validation and testing services from preclinical to commercial. The Changzhou facility offers technology platforms such as spray dried dispersion, continuous processing (flow chemistry), oligonucleotides and peptides. It successfully completed the first U.S. FDA inspection in 2018.
"WuXi STA takes high priority on building quality system meeting global regulatory standards. These successful FDA inspections to ASU and Changzhou facility reflects WuXi STA's commitment to 'quality first'. We will continue to enhance our platform with highest quality service to better enable our customers to bring better medicines faster for patients." added Dr. Minzhang Chen, CEO of WuXi STA.
