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These include 1) congenital pernicious anaemia, where there is a genetic defect in IF synthesis, leading to B12 malabsorption, 2) Imerslund-Gräsbeck Syndrome (IGS) caused by mutations in genes encoding cubulin and amnionless , 3) inherited HC or TCII deficiencies, and 4) intracellular cobalamin defects (CblA-CblG defects)

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FDA also explained that, unless specific limitations are included in a Bulks List entry, a listed bulk drug substance may be compounded for different uses and routes of administration