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Sponsored Artificial Intelligence: A Modern Approach, Global Edition Artificial Intelligence: A Modern Approach, Global Edition

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K. Harish

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Review Open access Sep 2026

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

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...

K. Harish, K. Nagasree, P. Laxmi et al. · 0 citations

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