LSNE Manufactures Commercial Sterile Drug Product
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 is a privately held company with six GMP facilities – four located in New Hampshire, one in Wisconsin and one located in León, Spain. LSNE has been providing contract lyophilization services to the pharmaceutical, biotechnology and medical device industries since 1997, specializing in a wide range of services including process cycle development, fill finish and lyophilization (for vials, pre-filled syringes and dropper bottles for ophthalmics), and analytical testing. Through the thoughtful integration of six processing facilities, qualified staffing, and an extensive manufacturing history, LSNE is strategically positioned to provide products and services for clinical through commercial supply for pharmaceuticals and medical devices to a multi-national market.