Breaking News on Global Pharmaceutical Technology & Manufacturing

Headlines > Ingredients

News in brief

US, foreign API facilities to see FDA fees spike in 2015

By Zachary Brennan+

Last updated on 05-Aug-2014 at 15:58 GMT

US and foreign API facilities will see their annual US FDA facility fees rise more than $5,000, while their FDF (fixed-dose form) counterparts will see their fees rise by more than $20,000.

The rise in fees for FY 2015 was not as steep as it was in 2014 , when FDF companies saw a more than $40,000 increase, while API facilities saw an $8,000 increase.

In the most recent tally, 795 API facilities identified themselves to the FDA through self-identification, which was down from the 903 identified last year. Of those, the 103 domestic facilities (down from 148 facilities) will pay $41,926 each, while the 692 foreign facilities (down from 775 facilities last year) will pay $56,926 each.

Domestic FDF facilities will each pay $247,717 in FY 2015, and foreign FDF facilities will each pay $262,717.

The total number of FDF facilities identified through self-identification was 681, which was down from 748. Of the total facilities identified as FDF, there were 271 domestic facilities (down from 315 facilities a year ago) and 410 foreign facilities (down from 433 facilities in 2014). 

The other generic drug fee rates for FY 2015, which will be in effect from Oct. 1 thru Sept. 30, 2015, include: ANDA (Abbreviated New Drug Application):$58,730; PAS (Prior approval supplement): $29,370; DMF (Drug Master File): $26,720.

Subscribe to our FREE newsletter

Get FREE access to authoritative breaking news, videos, podcasts, webinars and white papers. SUBSCRIBE

Related products

Key Industry Events


Access all events listing

Our events, Events from partners...