FDA Announces Generic Drug User Fee Rates for Fiscal Year 2027 (FY 2027)
The U.S. Food and Drug Administration (FDA) has released the FY 2027 Generic Drug User Fee Rates published under the Generic Drug User Fee Amendments of 2022 (GDUFA III). These fees are used to cover FDA review of generic drug applications, Drug Master Files (DMFs), FDA inspections of facilities, and FDA regulation of the generic pharmaceutical industry.
The FY 27 fee schedule will be in effect from October 1, 2026, to September 30, 2027. Those companies that file generic drug applications or those that are manufacturing facilities to support generic drug manufacturing should take the time to review these fees in their regulatory and financial planning.
FY 2027 Generic Drug User Fee Schedule
The FDA has finalized the following fee rates for Fiscal Year 2027:| Fee Category | FY 2027 Fee (USD) |
| Abbreviated New Drug Application (ANDA) | $375,684 |
| Drug Master File (DMF) | $109,899 |
| API Facility – Domestic | $39,680 |
| API Facility – Foreign | $54,680 |
| Finished Dosage Form (FDF) Facility – Domestic | $230,033 |
| Finished Dosage Form (FDF) Facility – Foreign | $245,033 |
| Contract Manufacturing Organization (CMO) Facility – Domestic | $55,208 |
| Contract Manufacturing Organization (CMO) Facility – Foreign | $70,208 |
| Generic Drug Applicant Program Fee – Large Size Operation | $1,927,291 |
| Generic Drug Applicant Program Fee – Medium Size Operation | $770,916 |
| Generic Drug Applicant Program Fee – Small Business | $192,729 |
Detailed Breakdown of FY 2027 Fees
- Abbreviated New Drug Application (ANDA) Fee
FY 2027 Fee: $375,684
The ANDA filing fee will be applicable to all ANDA filed with the FDA on or after October 1, 2026. This fee helps finance FDA’s scientific analysis of generic drug applications to guarantee generic products are comparable to their brand name counterparts in quality, safety and therapeutic equivalence.
This fee shall be paid when the ANDA is filed.
- Drug Master File (DMF) Fee
FY 2027 Fee: $109,899
A one-time fee for Type II Active Pharmaceutical Ingredient (API) Drug Master Files for the first time is referenced in a generic drug submission through an initial Letter of Authorization (LOA) fee.
This fee is to allow the FDA to perform the initial DMF completeness check prior to referencing the DMF in an ANDA.
- Active Pharmaceutical Ingredient (API) Facility Fees
Manufacturing facilities producing Active Pharmaceutical Ingredients (APIs) for approved generic drug products are subject to annual facility fees.
| Facility Type | FY 2027 Fee |
| Domestic API Facility | $39,680 |
| Foreign API Facility | $54,680 |
- Finished Dosage Form (FDF) Facility Fees
Facilities manufacturing finished pharmaceutical dosage forms for approved generic drugs are required to pay annual facility fees.
| Facility Type | FY 2027 Fee |
| Domestic FDF Facility | $230,033 |
| Foreign FDF Facility | $245,033 |
- Contract Manufacturing Organization (CMO) Facility Fees
Contract Manufacturing Organizations that manufacture generic drug products for ANDA holders are assessed separate annual facility fees.
| Facility Type | FY 2027 Fee |
| Domestic CMO Facility | $55,208 |
| Foreign CMO Facility | $70,208 |
Generic Drug Applicant Program Fees
The annual Generic Drug Applicant Program Fee depends on the number of approved ANDAs owned by a company and its affiliates.
| Applicant Category | Number of Approved ANDAs | FY 2027 Fee |
| Small Business | 1–5 | $192,729 |
| Medium Size Operation | 6–19 | $770,916 |
| Large Size Operation | 20 or More | $1,927,291 |
Companies are categorized annually based on the number of approved ANDAs they own as of October 1, 2026.
FY 2027 Revenue Allocation Under GDUFA III
The FDA allocates user fee revenue across several categories to support the Generic Drug User Fee Program.
| Revenue Category | Share of Total Revenue |
| Generic Drug Applicant Program Fees | 36% |
| ANDA Filing Fees | 33% |
| Finished Dosage Form & CMO Facility Fees | 20% |
| API Facility Fees | 6% |
| Drug Master File Fees | 5% |
The total targeted user fee revenue for FY 2027 is approximately $665.986 million, after applying the required statutory adjustments.
Important Dates
| Milestone | Date |
| FDA Fee Announcement | July 30, 2026 |
| Effective Date | October 1, 2026 |
| Fee Validity | September 30, 2027 |
What This Means for the Pharmaceutical Industry
The FY 2027 fee schedule affects:- Generic pharmaceutical manufacturers
- Active Pharmaceutical Ingredient (API) manufacturers
- Finished Dosage Form manufacturers
- Contract Manufacturing Organizations (CMOs)
- Drug Master File holders
- Regulatory affairs professionals
- Companies searching for a new ANDA submission
These updated FDA user fees should be part of organizations’ regulatory budgets, submission strategies, and annual compliance planning to ensure that the FDA doesn’t delay processing applications and to help prevent obligations to facilities.
How Masuu Global Supports Pharmaceutical Companies
Masuu Global offers pharmaceutical firms all over the world a full regulatory affairs and compliance consulting services. Our expertise includes: – Support in preparing and submitting ANDAs- Drug Master File (DMF) consulting
- FDA regulatory strategy
- USFDA compliance guidance
- Regulatory gap assessments
- Global dossier preparation
With all their expertise, our regulatory experts guide companies through changing FDA guidelines and ensure they submit on time and in compliance with all rules.
Conclusion
The FDA’s FY 27 Generic Drug User Fee schedule provides the official user fees that will apply from October 1, 2026, through September 30, 2027. Companies engaged in generic drug development, API manufacturing, DMF submissions and pharmaceutical manufacturing should take care to consider these fees and plan accordingly.
Keeping up to date with FDA regulatory developments ensures pharmaceutical companies remain compliant, prepared for submissions, and can effectively commercialize their products in the U.S. market.
Source: U.S. Food and Drug Administration (FDA) – Generic Drug User Fee Rates for Fiscal Year 2027 (GDUFA III).