Lyophilization Services of New England’s (LSNE) Bedford, NH facility has received a certificate of GMP compliance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture aseptic lyophilized drug products for use in the EU. An initial inspection in May 2013 found LSNE to be compliant with EU Good Manufacturing Practices, with no critical or major findings. After completion of the audit and registration, LSNE was issued a certificate of GMP compliance.
Matthew Halvorsen, president and chief executive officer of LSNE, said, "This is a tremendous accomplishment and is the direct result of thoughtful deployment of capital resources and years of hard work by many people across the company." This recent news provides LSNE the opportunity to become a long term manufacturing partner for its clients distributing products in the EU.