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FY 2020 GDUFA Fee Structure

FDA has now published FY 2020 GDUFA Fee.  Below is the summary of  FY 2020 GDUFA Fee structure.

FDA GDUFA Fee
FY 2020 GDUFA FEE , ANDA Fee

ANDA fee –  $ 176,237
DMF Fee – $57,795

Program Fee for ANDA applicants  

Large Size $ 1,590,792 $ 1,862,167 $ 1,661,684
Medium Size $ 636,317 $ 744,867 $ 664,674
Small Size $ 159,079 $ 186,217 $ 166,168

Definition 

Large Size : 20 or more approved ANDAs;
Medium Size :  between 6 and 19 approved ANDAs;
Small Size  : 5 or fewer approved ANDA

Facility Fee 

Domestic API $ 45,367 $ 44,226 $ 44,400
Foreign API $ 60,367 $ 59,226 $ 59,400
Domestic FDF $ 211,087 $ 211,305 $ 195,662
Foreign FDF $ 226,087 $ 226,305 $ 210,662
Domestic CMO $ 70,362 $ 70,435 $ 65,221
Foreign CMO $ 85,362 $ 85,435 $ 80,221