This list contains GDUFA facility payments received by the Agency. The following table explains the terms used in the list:
|Fiscal Year||The Fiscal Year for which the coversheet was created and paid.|
|Facility Name||The name of the facility for which the coversheet was created and paid.|
|Facility Address||The address of facility for which the coversheet was created and paid.|
|Facility FEI||The FEI number for which the coversheet was created and paid. This FEI number must match the address for the actual manufacturing facility. The FEI number must be a valid entry in order to capture the correct payment information. If an incorrect FEI is reported on the coversheet, the payment may be applied incorrectly, and the facility may be placed on the arrears list instead of the payments list.|
|Facility Payment Type
||There are three different facility payment types for which a facility fee coversheet can be generated and paid for—API, FDF or CMO. If a facility does not show a particular payment type, it means that the Agency has not received payment for that facility fee type.|
The payment information contained in this file reflects coversheets created and submitted in the User Fee System by each payor. The appearance of a facility on the GDUFA Facility Payments List does not indicate that a facility has fully satisfied its user fee obligations.
According to 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).
If the information contained in this file does not reflect your records, please contact the Agency via email at AskGDUFA@fda.hhs.gov to seek correction of your payment record.
Please note that the same facility may show up more than once due to incorrect submissions to the Agency; this does not indicate that the fee has been paid more than once. For practical reasons, it is difficult to remove these duplicate entries without significantly delaying updates to this list. The Agency has decided to not to remove such duplicates.
For additional information regarding GDUFA requirements, please visit the GDFUA main website.
Download the GDUFA Facility Payments List