Posted by Brigid Reamer On March - 19 - 2013 0 Comment

On January 16, 2013, the U.S. FDA published a Federal Register notice setting fiscal year (FY) 2013 fee rates for generic drug active pharmaceutical ingredient (API) and finished dosage form (FDF) facilities as required by the Generic Drug User Fee Amendments (GDUFA) of 2012.

Any person that owns a facility that is identified or intended to be identified in at least one generic drug submission that is pending or approved to produce one or more human generic drug FDFs and/or APIs is required to pay facility fee(s).

The FY 2013 fees are:

  • Domestic FDF facility: $175,389
  • Foreign FDF facility: $190,389
  • Domestic API facility: $26,458
  • Foreign API facility: $41,458

Generic Drug User Fee Amendments of 2012