List of Facilities Contributing to GDUFA Payments
This compilation includes GDUFA facility payments that the Agency has received. Below is a table defining the terms utilized in this compilation:
| Column | Description |
|---|---|
| Fiscal Year | This indicates the Fiscal Year for which the coversheet was generated and the payment was made. |
| Facility Name | The designated name of the facility for which the coversheet was created and payment was rendered. |
| Facility Address | The physical address of the facility linked to the coversheet generated and the payment made. |
| Facility FEI | The unique FEI number associated with the facility for which the coversheet was generated and the payment made. This FEI number must accurately correspond to the actual facility’s address. It is essential for this number to be valid for the accuracy of payment information. An incorrect FEI on the coversheet may lead to misallocation of payment, which could result in the facility being placed on the arrears list rather than the payments list. |
| Facility Payment Type |
Facilities can be categorized into three payment types for which a facility fee coversheet can be produced and paid for—API, FDF, or CMO. If a specific payment type does not appear for a facility, it indicates that the Agency has yet to receive payment for that type. |
Disclosure
The data displayed in this document reflects coversheets generated and submitted in the User Fee System by individual payors. The inclusion of a facility in the GDUFA Facility Payments List does not confirm that a facility has completely met its user fee responsibilities.
As indicated by the Generic Drug User Fee Amendments of 2017 (GDUFA II), “[f]acilities identified in at least one generic drug submission that is approved to produce a finished dosage form of a human generic drug or an active pharmaceutical ingredient contained in a human generic drug shall be subject to fees…” 21 U.S.C. § 379j-42(a)(4)(A) (2018). Under the Generic Drug User Fee Amendments of 2012 (GDUFA I), “[f]acilities identified, or intended to be identified, in at least one generic drug submission that is pending or approved to produce a finished dosage form of a human generic drug or an active pharmaceutical ingredient contained in a human generic drug shall be subject to fees…” 21 U.S.C. § 379j-42(a)(4)(A) (2012).
Should the information in this file not align with your records, please reach out to the Agency via email at AskGDUFA@fda.hhs.gov for assistance in correcting your payment records.
It is important to note that the same facility may appear multiple times due to incorrect submissions; this does not denote that the fee has been paid more than once. Given practical constraints, eliminating these duplicate entries is unfeasible without causing significant delays in updating this list. Therefore, the Agency has opted not to remove such duplicates.
For further details on GDUFA requirements, kindly visit the GDUFA main website.
Download the GDUFA Facility Payments List