Services to Ease FDA Regulatory Compliance

FY 2020 GDUFA Fee Structure

19

Aug

2019

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
BACK
Translate »