Generic Drug Manufacturing and Purchasing System
Notes: Abbreviations: FDA=Food and Drug Administration; ANDA=Abbreviated New Drug Application. The figure depicts the generic drug manufacturing and purchasing system, including regulatory approval provided by the FDA; the joint manufacturing enterprise of generic sponsors who hold ANDAs, suppliers of active ingredients and contract manufacturing organizations; drug purchasing by health systems and pharmacies who often go through intermediaries such as group purchasing organizations or wholesalers; and ultimately reimbursement that flows from patients and payers (e.g., insurance companies, Medicare) to the health systems and pharmacies that administer or dispense drugs to patients. Solid arrows indicate the direction of the flow of generic drug products or services, and dotted arrows the flow of payment.