US FDA issues warning letter to Sharon Bio-Medicine

09 Jul 2015 Evaluate

The US health regulator -- US Food and Drug Administration (US FDA) -- has issued a warning letter to Sharon Bio-Medicine for failing to pay generic drug user fee by its owner for three years starting 2013, saying its Dehradun-based facility would be barred from shipping products to the US if the dues are not cleared.

The company has failed to pay the appropriate facility fee for the facility as required by the Generic Drug User Fee Amendments of 2012 (GDUFA). The facility has not paid the 2013, 2014 and 2015 facility fees as required by GDUFA, it said without specifying the amount.

Sharon Bio-Medicine is into manufacturing and supply of Active Pharmaceutical Ingredients (APIs).

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