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A generic is a type of drug that is not protected by a patent and can be produced and sold by other companies once the patent on the brand-name drug expires.
The companies interested in producing and selling the generic version of a drug are required to file for approval with the relevant regulatory authorities.
The companies must provide detailed information about the generic drug, including its composition, manufacturing process, bioequivalence to the brand-name drug, and safety and efficacy data.
The purpose of generic drugs is to provide more affordable alternatives to brand-name drugs, increasing competition in the market and reducing healthcare costs for consumers.
The companies must report data on the safety, efficacy, and quality of the generic drug, as well as information on its bioequivalence to the brand-name drug.
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