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