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