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Blood 108, 13201327

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[DOI] [PubMed] [Google Scholar] Mora C.A., et al

While there is a slight increase in the DMF fee from US$ 95,084 in 2025 to US$ 102,584 in 2026, the ANDA fee has seen a sharp rise: from US$ 321,920 in 2025 to US$ 358,247 in 2026.FY 2025 and FY 2026 User Fee Rates Generic drug fee category Fees rates for FY 2025 Fees rates for FY 2026 Applications: Abbreviated New Drug Application (ANDA) US$ 3,21,920 US$ 3,58,247 Drug Master File (DMF) US$ 95,084 US$ 1,02,584 Facilities: Active Pharmaceutical Ingredient (API)Domestic US$ 41,580 US$ 43,549 APIForeign US$ 56,580 US$ 58,549 Finished Dosage Form (FDF)Domestic US$ 2,31,952 US$ 2,38,943 FDFForeign US$ 2,46,952 US$ 2,53,943 Contract Manufacturing Organization (CMO)Domestic US$ 55,668 US$ 57,346 CMOForeign US$ 70,668 US$ 72,346 GDUFA Program: Large size operation generic drug applicant US$ 18,91,664 US$ 19,18,377 Medium size operation generic drug applicant US$ 7,56,666 US$ 7,67,351 Small business generic drug applicant US$ 1,89,166 US$ 1,91,838 Our viewFor several years prior to the pandemic, India had a lead in Type II DMF submissions