According to a list published last week, 29 generic drug and associated active pharmaceutical ingredient (API) makers failed to pay facility fees to the US Food and Drug Administration (FDA) for the fiscal year 2015 as required by the Generic Drug User Fee Amendment (GDUFA).
The Amendment became law in May 2012 and requires that drugmakers pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities.
“Failure to timely submit the annual facility payment means that the FDA will not be able to receive new ANDAs [Abbreviated New Drug Application] or PASs [Post-Approval Studies] referencing these facilities,” the Agency stated.
API makers make up 19 of the 29 companies pulled up by the FDA. When broken down by country, the majority are based in Asia - eight are Indian and five are Chinese – while two are US domestic ingredient makers (Delavau and Natrium Products), one is Mexican, and the other three are Europe-based. The full list is below:
Granules, an India-based API maker, had been cited by the Agency but in a letter filed with the Bombay Stock Exchange (BSE) the firm said the annual facility fees had been paid before the October 2014 deadline, to which the FDA has since verified and removed the company from the list.
Failure to pay GDUFA fees can lead to FDA warning letters:
In October 2013, German CMO CPM Contract Pharma became the first to be hit with a letter after failing to self-identify itself as a manufacturing facility and pay registration fees, while last year India’s Marck Biosciences received an warning for failing to pay GDUFA fees for fiscal years 2013 and 2014.