LSNE Successfully Completes MHRA Inspection
LSNE's Bedford, New Hampshire Manufacturing Facility Receives Certificate of GMP Compliance from MHRA
MANCHESTER, N.H., Aug. 7, 2013 /PRNewswire/ -- Lyophilization Services of New England (LSNE), a New Hampshire based contract manufacturing organization is pleased to announce that their 25 Commerce Drive, Bedford NH facility 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 European Union. LSNE underwent an initial inspection in May 2013 and was found 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 of a Pharmaceutical Manufacturer from the MHRA. This certificate is a significant accomplishment for LSNE. The Bedford facility is now certified for the manufacture of sterile lyophilized drug products to be marketed in the European Union.
Matthew Halvorsen, President and Chief Executive Officer of LSNE, stated "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.
About LSNE Contract Manufacturing
LSNE Contract Manufacturing is a privately held company with three GMP facilities located in New England. LSNE has been providing contract lyophilization services to the pharmaceutical, biotechnology and medical device industries since 1997, specializing in a wide range of services including cycle development, cGMP fill/finish, and lyophilization. Through the thoughtful integration of three processing facilities, qualified staffing, and an extensive manufacturing history, LSNE is strategically positioned to provide uninterrupted manufacturing for clinical through commercial supply for medical device and pharmaceuticals to a multi-national market.