alexa Abstract | Generic Drugs-A Ground Discussion

International Journal of Drug Development and Research
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Abstract

A generic drug is a drug which is produced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active ingredient. A generic must contain the same active ingredients as the original formulation. According to the US Food and Drug Administration (FDA), generic drugs are identical or within an acceptable bioequivalent range to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic properties. By extension, therefore, generics are considered (by FDA) identical in dose, strength, route of administration, safety, efficacy and intended use. At present many health care products have been prominently provided by several pharmaceutical industries in India. Now the pharmaceutical industry is focusing on research of new chemical entities and products and development of generic products, because of the increased export market demands and competition for survival in Indian and foreign market. As more and more patents expire, sales of the generic portion of the pharmaceutical market are expected to increase day by day. The aim of this article is to access the usage of generic drugs

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Author(s): Khullar Rachit Goel Arvind Aggarwal Geeta

Keywords

Generic drugs, FDA regulations of generics, Pharmaceutical Industry

 
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