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Will produce sterile drug product
June 9, 2015
By: Kristin Brooks
Managing Editor, Contract Pharma
Lyophilization Services of New England, Inc. (LSNE) has completed a successful Pre-Approval Inspection (PAI) and GMP inspection, clearing the way for the company to manufacture commercial drug product for U.S. distribution. This is the second PAI at the Bedford, NH facility. The first inspection was for a bulk drug intermediate lyophilized in LSNE’s 260 sq.-ft. lyophilizer. Shawn Cain, chief operating officer of LSNE said, “The completion of this inspection is a critical milestone...
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