ANDA HOLDINGS
In today’s generic drug industry, intense cost pressure is a constant. We understand that every dollar counts, so we
provide an ANDA Holding service to help you manage costly annual Generic Drug User Fee Amendments (GDUFA)
Program Fees.
ANDA Holding Process
In the ANDA Holding process, ownership of an ANDA, or group of ANDAs, is transferred to Pharmobedient. Upon
transfer, Pharmobedient acts as a safe deposit box for your file. We safely store the ANDA until the time you want it
transferred back to you. Your information remains completely confidential, and we utilize our regulatory expertise to
maintain the file. We have an established procedure for handling ownership transfers that is simple and easy. For more
information, contact us at [email protected].
If you are considering discontinuing or withdrawing an ANDA, please keep in mind that discontinued ANDAs continue to
be counted in FDA’s Program Fee calculation. The only way to remove an ANDA from being counted in your Program
Fee is to withdraw the ANDA, a process which must be initiated by April 1 of the prior fiscal year, or to transfer
ownership.
If you are considering withdrawing an ANDA, please contact us [email protected] for a
proposal.
GDUFA Fee Information
GDUFA Program Fees are paid annually, on October 1, by all companies with an approved ANDA. The fee is categorized
into three tiers, Small, Medium, and Large, and the amount due is based upon the number of approved ANDAs held by a
company and its affiliates.
|
User Fee Type
|
|
FY 2024
|
FY 2025
|
|---|---|---|---|
|
ANDA
|
|
$ 252,453
|
$321,920
|
|
DMF
|
|
$ 94,682
|
$95,084
|
|
Program
|
Large Size
|
$ 1,729,629
|
$1,891,664
|
|
|
Medium Size
|
$ 691,852
|
$756,666
|
|
|
Small Size
|
$ 172,963
|
$189,166
|
|
Facility
|
Domestic API
|
$ 40,464
|
$41,580
|
|
|
Foreign API
|
$ 55,464
|
$56,580
|
|
|
Domestic FDF
|
$ 220,427
|
$231,952
|
|
|
Foreign FDF
|
$ 235,427
|
$246,952
|
|
|
Domestic CMO
|
$ 52,902
|
$55,668
|
|
|
Foreign CMO
|
$ 67,902
|
$70,668
|
|
Backlog
|
|
$ 17,434
|
$ 17,434
|
Contact
COMPANY
Strategy for complex issues in drug development and life-cycle management.
CONTACT
642 NE 3rd Avenue
Fort Lauderdale FL 33304
TEL. #
(954) 348-9455