If a generic company B is developing this manufacturer's API for their own ANDA in US market, and said USP standard is not enough in comparison to Originator's quality (impurity A = 0.1%). Then B claimed that A has to lower the imp level to 0.1%.
Q. Is it legal to use A's current API which can not meet Originator's API quality?
A. Sometimes FDA would ask for ICH standard which is stricter than USP. My understanding is that if B can pass BA /BE, it is legal to use A's material though it is inferior to originator's API.
It is possible to use API inferior to API used by originator to make dosage which is Bioequivalent to originator dosage.
Please refer to
http://www.fda.gov/cder/consumerinfo/generic_equivalence.htm
1. The Generic firm must assure the FDA that the raw materials and the finished product meet USP specifications, if these have been set.
2. Brand-name drugs are subject to the same bioequivalency tests as generics when their manufacturers reformulate them.
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