LSNE Successfully Completes MHRA Inspection

Aug 06, 2013

The CMO Lyophilization Services of New England (LSNE) reports that its manufacturing facility in Bedford, New Hampshire has received a Certificate of GMP Compliance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture asepticlyophilized drug products for use in the European Union. LSNE underwent an initial inspection in May 2013 and was found to be compliant with EU GMP, with no critical or major findings. After completion of an audit and registration, LSNE was issued a certificate ofGMP compliance of a Pharmaceutical Manufacturer from the MHRA. The Bedford facility is now certified for the manufacture of sterile lyophilized drug products to be marketed in the EU.

Source: LSNE