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Lyophilization Services of New England announces inspection approvals that will allow its Bedford, NH facility to begin manufacturing commercial drugs for US distribution.
On June 9, 2015, Lyophilization Services of New England (LSNE), a contract manufacturer of lyophilization services, announced the successful completion of a Pre-Approval Inspection (PAI) and General GMP Inspection by FDA in April 2015. The company’s manufacturing site, located in Bedford, NH, may now begin to manufacture commercial drugs for distribution within the US. Plans for 2015 also include “expansion of QC analytical testing capabilities, ICH stability chambers, additional complex formulation capabilities, as well as adding increased manufacturing capacity.”
"The completion of this inspection is a critical milestone for LSNE as it is the first PAI for a sterile product at the 25 Commerce Road facility. This is also our second site to now be successfully inspected by the FDA to produce commercial products in the past few months. This demonstrates LSNE's commitment to meeting all applicable regulatory standards for the production of commercial medical devices, bulk intermediates, and sterile injectable drugs,” said Shawn Cain, COO of LSNE, in a press release.