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
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
If you are considering withdrawing an ANDA, please contact us for a

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.

FY 2022 and FY 2023 User Fee Rates

User Fee Type


FY 2022

FY 2023



$ 225,712

$ 240,582



$ 74,952

$ 78,293


Large Size

$ 1,536,856

$ 1,620,556


Medium Size

$ 614,742

$ 648,222


Small Size

$ 153,686

$ 162,056


Domestic API

$ 42,557

$ 37,544


Foreign API

$ 57,557

$ 52,544


Domestic FDF

$ 195,012

$ 213,134


Foreign FDF

$ 210,012

$ 228,134


Domestic CMO

$ 65,004

$ 51,152


Foreign CMO

$ 80,004

$ 66,152



$ 17,434

$ 17,434

*Source: FDA website, amendments



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Strategy for complex issues in drug development and life-cycle management.


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