ABSTRACT

Generic and name-brand medications have similar risks as well as benefits. They also have the same active ingredients. The Abbreviated New Drug Application is used in the United States to approve generic drugs. The outcomes of bioavailability and bioequivalence studies are essential to the approval of generic drugs. From proof-of-concept to commercialization, developing a novel healthcare product (a drug) requires resources and time. It is the result of several years of development and study. Product development should adhere to all applicable regulatory standards to cut down on the amount of time and money needed to bring items to market. By adhering to these guidelines, you may maintain development efforts enduring while guaranteeing that the product you produce meets the stringent safety and effectiveness requirements of the country or countries you are considering. The goal of the study is to understand the regulations, approval process & also provide enough drug information to ensure safety and efficacy in humans. Keywords: Generic Drugs, ANDA, FDA, Healthcare Product, Name-Brand Medications
Publication date: 01/07/2025

https://ijbpas.com/pdf/2025/July/MS_IJBPAS_2025_9229.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.7.9229