WuXi AppTec’s WuXi STA has said that its facility at Waigaoqiao near Shanghai has cleared its first FDA drug product pre-approval inspection. Notably, the U.S. regulator had finished off the inspection in five days last year October. The review included the points which ranged from quality management to assessment of facilities, equipment, and labs, to tablet production, integrity of data as well as other elements that are a part of the manufacturing process.
Within the same time frame as the inspection by FDA, Wuxi said that their facility successfully passed two additional pre-approval inspections that were conducted for a couple of innovative drugs by NMPA, which happens to be China’s regulatory agency.
Minzhang Chen, who is the co-chief executive at WuXi AppTec as well as chief executive of WuXi STA said in a statement that he was very pleased that the Waigaoqiao drug product platform had successfully passed the first PAI by the U.S. FDA. He went on to add that it is another milestone for them as the company will start providing commercial drug product manufacturing services to the U.S.
The new facility near Shanghai can take care of pre-formulation, formulation development, solid-state development, and also commercial manufacturing that would span oral dosage forms range. It was not so long back in August of 2019 that WuXi Biologics had said that it would spend to the tune of $20 million to build a 60,000 sq.mt. site nearby Shanghai to manufacture antibody-drug conjugates which would be a part of its efforts to bloat the production capacity.