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USFDA Guidance: Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs
Introduction This guidance, "Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs ", published in March 2026 , provides detailed recommendations for applicants submitting Abbreviated New Drug Applications (ANDAs) for topical drug products. It focuses on physicochemical and structural (Q3) characterization, which plays a critical role in demonstrating product performance and bioequivalence (BE). Topical products, especially semisoli
Sharan Murugan
5 hours ago3 min read