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.

https://www.fda.gov/downloads/drugs/guidances/ucm321884.pdf

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