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