How much is the DMF Fee ?
How much is the DMF Fee ?
DMF fee is applicable only for type II DMFs (API or Drug Substance). There is no fee charged by FDA for packing material or excipient DMF.
FY 2019 , DMF fee is $ 55,013. This fee should be paid well before referencing your DMF in your ANDA application. However, you can still submit the DMF to FDA without paying the fees and wait for the ANDA sponsor.
After you pay the type II DMF fee FDA will review your DMF for completeness assessment. During completeness assessment FDA determines whether the DMF is available for reference or any other major changes required in the DMF . Most of the companies who want to source API (drug substance) prefer to go with the customer who has their product in the “DMF available for reference” list . You can find more information about the DMF completeness assessment at the below link.