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Copley $10.7 mil. penalty is largest generic manufacturer fine to date, Justice Dept. says.

This article was originally published in The Tan Sheet

Executive Summary

COPLEY WILL ALLOW FDA AUDIT OF 20 ANDAs IN CONNECTION WITH PLEA AGREEMENT reached with the Department of Justice and FDA. Under the agreement announced May 28, Canton, Mass.-based Copley Pharmaceutical will plead guilty to criminal charges of conspiring to defraud the government by failing to report changes in drug manufacturing processes to FDA. Copley will pay a criminal fine of $10.7 mil., a sum described by DOJ as the largest fine ever paid by a generic drug manufacturer.
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