Lyophilization Services of New England (LSNE)
, a privately held contract and development manufacturing organization (CDMO), has received approval of an Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA), for a sterile injectable product manufactured at their aseptic fill finish facility in León, Spain. The facility acquired in June 2019, is approved for U.S. commercial distribution making it LSNE's fourth facility to gain commercial approval.
"We are thrilled with this ANDA approval,” said Tom McGrath, vice president of quality and regulatory, LSNE. “LSNE is dedicated to supporting commercial drug manufacturing opportunities at our newest site and building on our commitment to quality, as evidenced by our successful regulatory history."
The LSNE-León site is an integral part of LSNE's overall growth strategy of increasing services, capacity and the footprint of its global network.