In order to get a generic drug approved in the US, companies must submit what is called an Abbreviated New Drug Application or ANDA.

This application is normally submitted to the US Food and Drug Administration’s Center for Drug Evaluation and Research Office of Generic Drugs.

As part of the drug review by the FDA the generics company must:

• Show that the active ingredient, strength, dosage form and administration are comparable to the originator product
• Prove that the generic drug is bioequivalent to the originator product
• Show that the labelling used is essentially the same as that of the originator product
• Document the generic drug’s chemistry, manufacturing processes and quality control measures.

The FDA must also ensure that the ingredients used meet the US pharmacopeia specifications, that the drug meets the stability requirements as labelled and complies with current good manufacturing practices. The proposed manufacturing site must also pass inspection by the FDA.