For chemistry, manufacturing, and controls (CMC) information, PEPFAR
ANDAs should follow the guidance for industry on Fixed Dose
Combinations, Co-Packaged Drug Products, and Single-Entity Versions of
Previously Approved Antiretrovirals for the Treatment of HIV.
For PET ANDAs, the Agency recommends a minimum of three batches at or
near the upper end of the proposed radio-concentration. If different
synthesizers (methods of synthesis) are used, three batches from each method
of synthesis at or near the upper end of the proposed radio-concentration are
recommended. Batches do not have to be made in the same facility. For any
additional manufacturing facilities, applicants should provide stability data on
at least one batch at or near the upper end of the proposed radio-concentration
from each facility, although bracketing approaches may be submitted for
review.
