COMPARATIVE ANALYSIS OF REGULATORY REQUIREMENTS FOR FIXED DOSE COMBINATIONS (FDCs) IN INDIA, US AND EU

Authors

  • Swamy Sekhar Gannabathula, Raghava.D, 3Nageswara Rao.K, Naga Sravani.P Author

DOI:

https://doi.org/10.48047/

Keywords:

Fixed Dose Combinations (FDCs), Regulatory Requirements, Drug Approval Process, Clinical Data Requirements, Post-Marketing Surveillance, Regulatory Harmonization

Abstract

Fixed Dose Combinations (FDCs) have become an essential aspect of modern therapeutic strategies, particularly for chronic and infectious diseases. However, regulatory requirements for approval and marketing of FDCs vary significantly across regions. This project aims 

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Published

2025-10-07

Issue

Vol. 16 No. 10 (2025): Volume 16 Issue 10 (2025)

Section

Articles