Skimming the document it was apparent that it is not in a company's better interest to mess with the FDA; they have an arsenal of red tape to tie up those who do.
"Amphastar’s ANDA does not (IMO) have what it takes to get FDA approval—ever."
Given that the major issues were with the Chinese suppliers, is it not possible to rectify these problems? Would it mean submission of a new ANDA? Is this practical, given the present landscape of mL and other treatments on the horizon.
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