Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

UsernamePublicRestriction

Generic Industry Consolidating But Still Mysterious

Executive Summary

Nearly 2,000 ANDAs remain unclaimed as US FDA begins fee calculations for GDUFA II.

You may also be interested in...



ANDA Submissions Drop To Start FY2021

First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.

ANDA Submissions Drop To Start FY 2021, Perhaps Forced Down By COVID-19

First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.

FDA Reports Millions In Unpaid GDUFA Fees

The $20m in generic drug user fee receivables was 12% of the estimated total to be collected in 2018.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS120801

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

Cancel