What standards do generic
drugs have to meet?
Health professionals and consumers can be assured that FDA
approved generic drugs have met the same rigid standards as the innovator drug.
To gain FDA approval, a generic drug must:
1. It should contain the same active ingredients as the
innovator drug(inactive ingredients may vary)
2. It should be identical in strength, dosage form, and route
of administration
3. It should have the same use indications
4. It should be bioequivalent
5. It should meet the same batch requirements for identity,
strength, purity, and quality
6. It should be manufactured under the same strict standards
of FDA's good manufacturing practice regulations required for innovator
products.
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