LSNE recently completed a successful Pre-Approval Inspection (PAI) at its facility in Bedford, NH, with no Form 483 issued, and no observations noted by the FDA.
 
The site received approval to manufacture a commercial drug product for U.S. distribution. The facility is dedicated to the aseptic filling and lyophilization of a product that is currently on the market.
 
We are very happy with the positive results of the latest FDA inspection, which is another important milestone and further adds to our successful regulatory history. This approval is the culmination of years’ worth of preparation and diligence and this success helps position us for our future growth. Specifically, we are looking to expand our analytical capabilities to better support all of our client’s needs,” said Shawn Cain, chief operating officer, LSNE Contract Manufacturing.
 
LSNE has added capabilities across its three sites in 2014, and in 2015 plans to expand QC analytical testing capabilities, ICH stability chambers, add complex/potent compound handling capabilities, as well as increase manufacturing capacity.