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January 14, 2009
By: Tim Wright
Editor-in-Chief, Contract Pharma
The FDA completed an inspection of Apicore LLC‘s kilo-scale API manufacturing site in Somerset, NJ. The inspection took place December 12-15, 2008, according to Compliance Program 7356.002F, “Drug Manufacturing Inspections for Bulk Pharmaceutical Chemicals.” This was the second successful inspection of the site since 2006. Apicore provides process development and manufacturing services according to ICH guidelines for new chemical entities (NCE) and existing APIs for off-patent drug prod...
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