Lyophilization and Sterile Manufacturing for Pharmaceuticals - LSNE-Manchester · 2020. 5. 5. ·...
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Transcript of Lyophilization and Sterile Manufacturing for Pharmaceuticals - LSNE-Manchester · 2020. 5. 5. ·...
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• LSNE-Manchester
• LSNE-Bedford
• 25 Commerce Drive
• 19 Harvey Road
• LSNE-León
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Medical Device Manufacturing Facility
Commercial Services
1 Sundial Avenue, Manchester, NH 03103
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FDA General GMP Inspection
FDA General GMP Inspection
FDA General GMP Inspection
(QSIT Inspection)
FDA General GMP Inspection
FDA Pre-Approval Inspection
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FDA General GMP Inspection
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FDA General GMP Inspection
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ANVISA GMP Inspection
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Established
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Drug Product & Medical Device Manufacturing Facility
Clinical and Commercial Services
25 Commerce Drive, Bedford, NH 03110
Drug Product Manufacturing Facility
Commercial Services
19 Harvey Road, Bedford, NH 03110
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*Inspection performed under campus designation with 19 Harvey Road
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MHRA Inspection FDA Pre-Approval &
GMP Inspection
FDA General
GMP Inspection*
FDA Pre-Approval &
GMP Inspection
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Established
FDA Pre-Approval &
GMP Inspection
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*Inspection performed under campus designation with 25 Commerce Drive
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FDA General GMP Inspection
FDA Pre-Approval & GMP Inspection
FDA General GMP Inspection*
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Established
FDA Pre-Approval (QC) & GMP Inspection
FDA Pre-Approval & GMP Inspection
FDA Pre-Approval & GMP Inspection
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Drug Product Manufacturing Facility
Clinical and Commercial Services
León, Spain
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FDA Pre-Approval & GMP Inspection
Acquired in June
FDA Pre-Approval Inspection
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AEMPS Inspection
Established
Previous Ownership
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• For more information about our regulatory history and service offerings.
603.668.5763
mailto:[email protected]
