Abstract
A generic drug is a product that is comparable to brand/reference listed drug product in dosage form, potency, route of administration, quality and intended use. Generic drugs are equal and within the acceptable bioequivalence range to the brand name drugs. Branded drugs are typically sold at elevated prices as a large substantial human intervention is applied from inception to commercialization. For taking approval of generics, ANDA (Abbreviated New Drug Application) is filed. An approval of generic drug product requires rigorous standards established by the drug authority with respect to identity, strength, quality, purity, and potency. However, some variability can and does occur during manufacturing, for both brand name and generic drugs. When a drug, generic or brand name, is mass-produced, very small variations in purity, size, strength, and other parameters are permitted. Keywords: ANDA, ICH, NDA
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