Regulatory Challenges in Filing ANDA for Immediate-Release Solid Oral Dosage Forms

Abstract

The pharmaceutical industry plays a critical role in providing safe, effective, and affordable medicines. Generic drugs, particularly immediate-release (IR) solid oral dosage forms, are essential for reducing healthcare costs and improving patient access. In the United States, generic drug approval is regulated through the Abbreviated New Drug Application (ANDA) process by the US FDA. Despite their apparent formulation simplicity, ANDA submissions for IR products face complex regulatory challenges. This study aims to identify and analyze these challenges, focusing on Chemistry, Manufacturing, and Controls (CMC), bioequivalence, dissolution testing, analytical method validation, stability studies, GMP compliance, data integrity, and eCTD submissions. A descriptive, analytical methodology was employed, using secondary data from regulatory guidelines, FDA publications, and literature reviews. The findings reveal that CMC deficiencies, BE failures, and dissolution inconsistencies are the most frequent hurdles. Strategies for improving submission quality, minimizing regulatory delays, and enhancing approval success are discussed. This study provides valuable insights for regulatory professionals and generic drug manufacturers.