Lyophilization Services of New England (LSNE) 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.
"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," Vice President of Quality and Regulatory, Tom McGrath, said.