What are the Various USDMF fees to an applicant from a pharmaceutical industry:-

What are the various USDMF fees

The various USDMF fees are as follows ¹ ²:

- *DMF fee*: This is a one-time fee incurred when a DMF is first referenced in a generic drug submission. The fee for FY 2025 is $95,084.

- *ANDA fee*: This fee is paid by the ANDA applicant and is used to fund the review process. The fee for FY 2025 is $321,920.

- *Program fee*: This is an annual fee paid by companies based on the number of approved ANDAs in their portfolio. The fee for FY 2025 ranges from $189,166 (small size) to $1,891,664 (large size).

- *Facility fee*: This fee is paid by facilities that manufacture APIs or finished dosage forms. The fee for FY 2025 ranges from $41,580 (domestic API) to $246,952 (foreign FDF).

Note that these fees are subject to change and may not reflect the current fees. It's always best to check with the FDA for the most up-to-date information.