FDA Registration generic drug

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
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