Generic drug approval

Generic drug approval is the regulatory process by which a pharmaceutical company gains permission to sell a medication that is equivalent to a brand-name drug in dosage, safety, strength, administration, quality, and intended use. The process involves demonstrating that the generic has the same active ingredients and performs the same in the body. Since the original drug’s safety and efficacy have already been established, the review is focused on confirming bioequivalence and quality standards. This streamlines approval, making essential medications more affordable while maintaining safety and effectiveness.