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Such data are lacking for most of these peptides Scott Brunner Therefore, the FDA will have to look at this issue from a different angle. Therefore, the FDA will have to look at this issue from a different angle. Scott Brunner Placement on the 503A Bulks List is not an approval of the drug, but a regulatory question: does the peptide meet certain criteria so that pharmacies can prepare it from bulk ingredients under a patients prescription

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The global CDMO market for peptides and oligonucleotides is projected to reach $5.67 billion by 2030, growing at 12.5% annually, and the companies announcing capacity expansions are competing for long-term supply agreements in a market where qualified manufacturing space is the limiting resource