ANDA
An Abbreviated New Drug Application is the route for approval of a generic medicine in the United States. Rather than repeating clinical trials, the applicant shows that the product is pharmaceutically equivalent and bioequivalent to an approved reference product. The application relies on DMFs for its API and on robust impurity data, which in turn require qualified reference standards.
Related terms
API (Active Pharmaceutical Ingredient)
An Active Pharmaceutical Ingredient is the substance in a medicine that produces its therapeutic effect. APIs…
Drug Master File (DMF)
A Drug Master File is a confidential submission to a regulator, most often the US FDA, that describes how a s…
ICH Q3A and Q3B
Two International Council for Harmonisation guidelines on impurities in new drug substances (Q3A) and new dru…
Reference Standard
A highly characterised material used as a benchmark to confirm identity, measure assay or quantify impurities…
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