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Mylan's Agila Challenge: FDA Throws Down the Glove

This article was originally published in RPM Report

Executive Summary

The Food & Drug Administration’s September 9 warning letter to one of the eight Agila production facilities that Mylan is set to take control of by the end of this year shows both the depth of process issues that need to be cleaned up and the relatively good standing of the Agila facility vis-à-vis some of the other Indian facilities the FDA has recently visited.

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