For FY 2023, the FDA generic drug User Fee rates are: ANDA ($240,582), DMF ($78,293), domestic API facility ($37,544), foreign API facility ($52,544), domestic FDF facility ($213,134), foreign FDF facility ($228,134), domestic CMO facility ($51,152), foreign CMO facility ($66,152), large size operation generic drug applicant program ($1,620,556), medium size operation generic drug applicant program ($648,222), and small business generic drug applicant program ($162,056). These fees are effective on October 1, 2022, and will remain in effect through September 30, 2023. ITB HOLDINGS LLC 390 North Orange Avenue, Suite 2300 Orlando, FL 32801 United States T: +1 855 389 7344 T: +1 855 510 2240 T: +44 800 610 1577 https://www.usfda.info/drugs/
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