Generic Drug User Fee Rates for Fiscal Year 2027

Table 1—Fee Schedule for FY 2027 Fee category Fee rates for FY 2027 Applications: Abbreviated New Drug Application (ANDA) $375,684 Drug Master File (DMF) 109,899 Facilities: Active Pharmaceutical Ingredient (API)—Domestic 39,680 API—Foreign 54,680 Finished Dosage Form (FDF)—Domestic 230,033 FDF—Foreign 245,033 Contract Manufacturing Organization (CMO)—Domestic 55,208 CMO—Foreign 70,208 GDUFA Program: Large size operation generic drug applicant 1,927,291 Medium size operation generic drug applicant 770,916 Small business generic drug applicant 192,729II. GDUFA III specifies that the CMO facility fee is to be equal to 24 percent of the FDF facility fee. The foreign FDF facility fee is $15,000 more than the domestic FDF facility fee, or $245,033. The foreign API facility fee is $15,000 more than the domestic API facility fee, or $54,680. Table 8—Fee Schedule for FY 2027 Fee category Fee rates for FY 2027 Applications: Abbreviated New Drug Application (ANDA) $375,684 Drug Master File (DMF) 109,899 Facilities: Active Pharmaceutical Ingredient (API)—Domestic 39,680 API—Foreign 54,680 Finished Dosage Form (FDF)—Domestic 230,033 FDF—Foreign 245,033 Contract Manufacturing Organization (CMO)—Domestic 55,208 CMO—Foreign 70,208 GDUFA Program: Large size operation generic drug applicant 1,927,291 Medium size operation generic drug applicant 770,916 Small business generic drug applicant 192,729X.