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By extension, therefore, generics are considered (by the FDA) identical in dose, strength, route of administration, safety, efficacy, and intended use. 4, the FDA's use of the word "identical" is very much a legal interpretation, and is not literal.. 13 Regulation edit Most nations require generic drug manufacturers to prove their formulation exhibits bioequivalence to the innovator product. Bioequivalence, however, does not mean generic drugs must be exactly the same (pharmaceutical equivalent) as their innovator product counterparts, as chemical differences may exist (different salt or ester a pharmaceutical alternative).. When applying to sell a generic equivalent of a brand name drug, the manufacturer must prove that the product is as safe and effective as the branded version. The manufacturer must also prove to the Provincial Ministries of Health that the active ingredients in the medicine are as pure, dissolve at the same rate, and.


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