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LSNE Completes MHRA Inspection

Gains GMP certificate to manufacture aseptic lyophilized drugs in EU

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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 Halv...

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