Bedford, NH – Lyophilization Services of New England (LSNE), has been notified by one of its clients that their ANDA for a commercial sterile product, listing LSNE as the sole drug product manufacturing site, has recently been approved by the FDA. This product sparked the most recent FDA inspection (PAI) of the 25 Commerce Drive manufacturing site in April of 2015. While this is not the first commercial approval for the 25 Commerce Drive site, it does mark the first commercial aseptic product approved to be manufactured at the site. Additionally, this is the first approved drug which referenced LSNE’s TYPE V DMF.
LSNE Manufactures Commercial Sterile Drug Product