LSNE Receives Approval to Manufacture Commercial Aseptic Generic Product at its Recently Acquired Facility in León, Spain

Sep 2019

LSNE-León is the Fourth Facility to Gain Commercial Approval

September 30, 2019, Bedford, NH – Lyophilization Services of New England (LSNE), a privately held contract and development manufacturing organization, announces approval of an Abbreviated New Drug Application (ANDA) from the US 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 US commercial distribution making it LSNE’s fourth facility to gain commercial approval.

Vice President of Quality and Regulatory, Tom McGrath, stated, “We are thrilled with this ANDA approval. 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.