Drug Approval | August 08, 2023
The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
The newly launched Genomic Health Insights (GHI) program to make sequencing accessible to all
Adding 20,000 liters of installed biologics drug substance manufacturing capacity
The inspection closed with the facility receiving an inspection classification of NAI
The company will submit its comprehensive response on these observations to the US FDA
The EU certification will support supplies of drug products registered in Europe, from this manufacturing site
New facility will strengthen the security of supply for global pharmaceutical and biotech customers and will support the continued development and production of lifesaving clinical and commercial-scale therapeutics for patients worldwide.
Construction will begin this year with the new capacity anticipated by 2025
The new recycling facility, Recover Louth, is the second addition to Coveris’ closed loop recycling business segment
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