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According to the FDAs 503A compounding information, bulk substances must be accompanied by a valid certificate of analysis and manufactured by an establishment registered with the FDA under Section 510 of the Federal Food, Drug, and Cosmetic Act
NHEK was cultured in KBM2 supplemented with 0.4% bovine pituitary extract, 0.33 g ml 1 hydrocortisone, 0.39 g ml 1 epinephrine, 10 g ml 1 transferrin and 1.8 mM CaCl 2 , with or without hHGF or dimeric macrocycle
Yu et al., 2017)
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