No. For ANDAs that contain multiple strengths (that are dose proportional),
three separate intermediate bulk granulations (or blends) should be
manufactured. One batch of bulk granulation (or blend) should be used to
manufacture all the strengths proposed. The other two bulk granulations (or
blends) can be used to manufacture only the lowest and the highest strengths,
in addition to the strength used in BE studies (i.e., the strength(s) tested in the
BE studies should have three batches). Stability testing should still use all
three batches of drug product.
