Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Generic Facility Fee Unlikely To Be Charged Until A Few Months After GDUFA Implementation

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA will need a bit of time to develop a comprehensive database of all the facilities that produce active pharmaceutical ingredients and finished dosage forms for the U.S. market as part of the proposed generic drug user fee program.

You may also be interested in...

GDUFA II: ANDAs, Not Facilities Will Govern Revenue

Since applications comprise most of the workload, they will be the focus in the next generic drug user fee cycle.

GDUFA Facility Fees Will Be Significantly Higher Than Expected

Fewer fee-paying facilities than estimated self-identified with the agency as part of the launch of the generic drug user fee program, which helped increase the fees about 17% more than anticipated for domestic finished dosage form facilities.

GDUFA Facility Self-Identification Pace Slow As Deadline Neared

API, finished dosage form and other facilities in the generic drug supply chain must submit information to FDA by Dec. 3. As of Nov. 18, about one-third had complied, potentially affecting user fee amounts.

Related Content


Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts