How much is ANDA fee?
How much is GDUFA ANDA fee?
ANDA fee for FY 2022 are as below.
ANDA fee – $ 225,712 . This fee is applicable for each ANDA.
ANDA Program fee – This is the annual for ANDA holder.
| Large Size | $ 1,536,856 |
|---|---|
| Medium Size | $ 614,742 |
| Small Size | $ 153,686 |
Large: 20 or more approved ANDAs;
Medium: between 6 and 19 approved ANDAs;
Small: 5 or fewer approved ANDAs
FDA Facility Fee – Annual fee for each facility involved in the ANDA
| Domestic API | $ 42,557 |
|---|---|
| Foreign API | $ 57,557 |
| Domestic FDF | $ 195,012 |
| Foreign FDF | $ 210,012 |
| Domestic CMO | $ 65,004 |
| Foreign CMO | $ 80,004 |
API – Active Pharmaceutical Ingredient (drug substance manufacturer)
FDF – Finished Dosage Manufacturer
CMO – Contract Manufacturing Organization
Drug Master File fee 74,952 , only applicable for Type II DMF