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[30] The main type of vitamin B 12 deficiency anemia is pernicious anemia, [31] characterized by a triad of symptoms: Anemia with bone marrow promegaloblastosis (megaloblastic anemia)

The vitamin B12 market has experienced significant growth in recent years, with an estimated 9.8% annual growth rate in India

Injectable routes carry a particular concern for immunogenicity from peptide aggregation and impurities, and FDA noted the available certificates of analysis for AOD-9604 bulk drug substances did not consistently control for impurities, aggregates, or microbial limits