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The agency said the company failed to meet CGMP requirements, including implementing and adhering to its risk-based corrective and preventive action (CAPA) procedures

Notably, in contrast to 23 (HA08), a structurally very similar epimer (HA09) which differs only with regard to one stereogenic center and exhibiting a 100-fold lower affinity to IRAP did not affect spine morphology, indicating a correlation between the capacity to inhibit IRAP and a positive impact on DSD and spine morphology

While tirzepatide does not directly affect B12 absorption like metformin, reduced intake of animal productscommon during appetite suppressionmay lead to inadequate B12 levels

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