USFDA GDUFA User Fee Rates for FY 2027 | Key Takeaways & Trends

The US FDA officially announced the updated Generic Drug User Fee Amendments (GDUFA III) fee schedule for Fiscal Year 2027 (effective Oct 1, 2026 – Sept 30, 2027).

Here is a quick breakdown of where fees are headed and what it means for generic drug manufacturers, API suppliers, and CMOs:

Application Fees are UP

• ANDA Fee: $375,684 (+4.87%) 
• DMF Fee: $109,899 (+7.13%) 

Facility Fees are DOWN Across the Board

• API Facilities: Domestic ($39,680) & Foreign ($54,680) both down ~6% to 8%. 
• FDF Facilities: Domestic ($230,033) & Foreign ($245,033) down ~3.5%. 
• CMO Facilities: Domestic ($55,208) & Foreign ($70,208) down ~3% to 3.7%. 

Program Fees Remain Flat

• Large, Medium, and Small business program fee tiers saw only a minor +0.46% adjustment.