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Obesity and obesity-related diseases are a major public health issue worldwide

With rising demand comes new challenges: capacity constraints, shifting regulatory expectations, and the unique requirements of emerging modalities, like cell and gene therapies, are reshaping the fill/finish landscape

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These include specific kidney conditions such as distal renal tubular acidosis and medullary sponge kidney, gout, hyperparathyroidism, inflammatory bowel disease (particularly Crohn's disease), and recurrent urinary tract infections

However, it is not currently FDA-approved for any condition and is expected to remain in the investigational phase for the near future