The US Food and Drug Administration (FDA) has announced the user fees for fiscal year 2024, setting amounts that will apply to manufacturers of pharmaceuticals, generic drugs, biosimilars, and medical devices. As per the Generic Drug User Fee Act (GDUFA), published on July 28, 2023, as of October 30, 2023, 1.320 facilities had already paid their registration fee for fiscal year 2024. This figure includes active pharmaceutical ingredient (API), finished dosage form (FDF), and contract manufacturing services (CMO) sites. Teva Pharmaceuticals topped the list of companies by facility registrations, followed by Aurobindo Pharma and Viatris. India leads in total facility registrations with the FDA for fiscal year 2024, followed by the United States and China. The GDUFA, designed to streamline access to safe generic medicines and reduce costs, was reauthorized in September 2022 as GDUFA III and will remain in effect until September 2027.
Find out why India ranks first above the United States and China by reading the full story in our Gaffel News Magazine: https://www.flipsnack.com/CCA6559BDC9/gaffel-news-edici-n-19-diciembre-2023/full-view.html