ANDA (Abbreviated New Drug Application)
The US FDA application pathway for approving a generic drug, requiring bioequivalence data and a USFDA-inspected manufacturing facility.
Definition
An Abbreviated New Drug Application is the US FDA's regulatory pathway for approving a generic pharmaceutical, requiring bioequivalence studies and manufacture at a USFDA-inspected facility. It is a multi-year, high-cost process — WHO-GMP certification alone does not qualify a product for the US market.
Why It Matters
This is why finished-formulation export to the US is not a realistic near-term goal for a new merchant exporter without an ANDA-holding manufacturing partner — we're transparent about this rather than implying otherwise.
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