ABSTRACT

Generic drug products, also referred to as multi-source medicines, are drug products containing the same active pharmaceutical drug ingredient (API) in the same dosage form as that marketed by the innovator (brand) company. Generic drug products that meet national regulatory requirements for therapeutic equivalence and are approved by a regulatory agency can be substituted for their brand name counterparts with the full expectation that the generic drug product will produce the same clinical effect and safety profile as the prescribed product.