If you propose to add additional sources of API for the same drug substance,
you should provide the following CMC information:
• Comparison and justification of comparability (by the applicant) of the
physico-chemical properties and impurities of the drug substance from
each source.
• Appropriate stability data on three batches of drug product qualifying
the first API source used in the bioequivalence (BE) studies as
recommended by the FDA stability guidance.
• A single pilot scale batch of the drug product bio-strength(s)
manufactured using the second or each of the other proposed API
source(s) used to support the ANDA application, along with
comparative dissolution data.
• Appropriate stability data (accelerated and long-term for 6 months at
the time of filing) on the strength(s) manufactured for each API
source. Appropriate stability data may in some cases include
intermediate condition stability data.
