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LSNE’s Spain Site Gets FDA Approval

LSNE-León is the fourth facility to gain commercial approval

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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.     &#822...

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