What are the Various USDMF fees to an applicant from a pharmaceutical industry:-
Sep 12
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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.
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