For purposes of self-identification and payment of fees, GDUFA defines API and
FDF manufacturers somewhat differently from the way these traditional categories
of manufacturers have been defined historically. For example, generic drug
manufacturers who mix an API when the substance is unstable or cannot be
transported on its own are considered API manufacturers and not FDF
manufacturers for self-identification and the payment of GDUFA user fees only.
GDUFA defines an FDF as:
(A) a drug product in the form in which it will be administered to a patient, such as
a tablet, capsule, solution, or topical application;
(B) a drug product in a form in which reconstitution is necessary prior to
administration to a patient, such as oral suspensions or lyophilized powders; or
(C) any combination of an active pharmaceutical ingredient (as defined in the
statute) with another component of a drug product for purposes of production of
a drug product described in subparagraph (A) or (B).
GDUFA defines an API as:
(A) a substance, or a mixture when the substance is unstable or cannot be
transported on its own, intended—
(i) to be used as a component of a drug; and
(ii) to furnish pharmacological activity or other direct effect in the diagnosis,
cure, mitigation, treatment, or prevention of disease, or to affect the
structure or any function of the human body; or
(B) a substance intended for final crystallization, purification, or salt formation, or
any combination of those activities, to become a substance or mixture described
in subparagraph
