A Comprehensive Review of Current Trends and Regulatory Frameworks in Generic Drug Development
Year: 2025
Type: article
Abstract: Generic drug development is a scientifically rigorous process distinct from innovator drug development, focusing on bioequivalence to ensure comparable safety, efficacy, and therapeutic outcomes. As innovation-driven drug development remains time and cost intensive, many pharmaceutical industries particularly in developing countries prioritize generics as a viable alternative. Current generic drug development integrates Quality by Design (QbD) principles to enhance product and process understanding, while continuous manufacturing and Process Analytical Technology (PAT) tools are increasingly adopted to ensure real-time quality control and regulatory compliance. Despite lower costs and faster timelines, developers face complex challenges in mapping innovator quality and meeting diverse, stringent regulatory standards across global regulatory such as FDA (US), EMA (Europe), PMDA (Japan), HC (Canada), CDSCO (India), TGA (Australia) etc. This review provides a comprehensive analysis of the evolving trends, scientific strategies, and regulatory frameworks shaping generic drug development, highlighting critical stages from API, excipient selection to bioequivalence, and the role of advanced manufacturing and evaluation tools in ensuring product stability, quality and approval readiness.
Author: Chinna Reddy Palem*, Ravindar Rendla, Nishanth Kumar Nagamalli, Vamshi Krishna Lekkala, Sridhar Gumudevelli
Language: English
Subfield: Economics and Econometrics
Domain: Social Sciences
Open Access status: green
OpenAlex ID: W7085642878
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