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Under this process, the generic manufacturer uses the safety and efficacy data supplied by the brand company, and must only prove to the FDA that its generic product is equivalent to the branded product. The FDA does not require the generic company to conduct separate and complete clinical studies for safety and efficacy because the brand drug has been used safely for many years.

In order to receive FDA approval, a generic must have the same active ingredients, same dosage form, same standards for purity and quality, same standards for manufacturing, same amount of drug absorbed over the same time, and same clinical effect as the brand product.

The FDA also requires that a generic company’s manufacturing methods conform to current good manufacturing practices (cGMP), as defined in the U.S. Code of Federal Regulations. The company must follow the cGMPs in all phases of the manufacturing process, and continually monitor compliance and measure quality control.

Once all FDA requirements are met, a generic drug is given approval and typically dispensed under the chemical name of the active ingredient, although generic manufacturers may also choose to market specific generic drugs under a unique trade-name. Occasionally generics may be a slightly different size, shape or color than their brand counterpart, but these cosmetic differences have no impact on the safety or effectiveness of a generic prescription drug.

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