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what you should know about GDUFA II

In the month of August  FY 2018 fees for generic drug application will be published,  which will be based on GDUFA II. We have summarized highlights  of GDUFA II fee structure and how it will benefit small business.

GDUFA II Highlights  

No fees for  ANDA supplement fees

No facility fees for manufacturing  facilities with unapproved ANDA

If you are just contract manufacturer and do not have affiliation with any ANDA holding  organization then you will pay only one tenth of  proposed  facility fees.

Now ANDA sponsor companies  will pay fixed annual ANDA Sponsor Program fee which depends on the number of ANDAs owned by companies. ANDA fees are divided in three tiers. small, medium and big.

  • Large (companies with 20 or more approved ANDAs);
  • Medium (companies with between 6 and 19 approved ANDAs); and,
  • Small  (companies with 5 or fewer approved ANDAs).

Facilities  which manufacture   both API and FDF will only pay FDF facility fee, as per GDUFA I both API and FDF fees were applicable to such facilities.

GDUFA II has brought relief to small companies who have no approved ANDA , they need not pay the facility fee until ANDA is approved. Once ANDA is approved facility  is applicable from next fiscal year irrespective whether product is in commercial distribution or not.

GDUFA II has also brought  big relief  to contract manufacturing organizations (CMO)   who just manufacturer the product for another ANDA sponsor and do not hold ownership of other  ANDAs or affiliated with companies who own ANDAs  .

If you have any question on GDUFA II fee program please contact us.