FDA May Block Imports From Indian Generic Drug Facility
The Food and Drug Administration recently warned an Indian drug company that it may block admission of its products at the border for failure to pay generic drug user fees. In a warning letter dated Aug. 28, FDA notified Marck…
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Biosciences Limited that it failed to pay fees for 2013 and 2014 required by the Generic Drug User Fee Amendments of 2012 for a facility in Gujarat. The facility has been placed on the GDUFA arrears list (here), and drugs manufactured at the facility may be refused admission to the U.S. as a result, said FDA.