Elite Pharmaceuticals Inc (ELTP)

[NASDAQ2020]

The GDUFA program fee is a fee structure for the pharmaceutical industry. The medium size operation GDUFA program fee is 40 percent of the full fee, which is $614,742, and the small business operation GDUFA program fee is 10 percent of the full fee, which is $153,68612. Under the GDUFA II fee structure, a firm and its affiliates will pay one program fee commensurate with the number of approved ANDAs that the firm and its affiliates collectively own3. GDUFA I required industry to pay approximately $300 million in fees each year of the five year program4. GDUFA II provides that user fees should total $493,600,000 annually adjusted each year for inflation5.