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Challenges for Manufacturers using BPO

Quality

  • Monograph requires USP grade actives

Production

  • Must be milled and dispersed at customer location
  • Bulk BPO typically has larger particle sizes

Safety

  • Potentially explosive when milled
  • 75% USP is hazardous

Cost

  • Significant capital costs of equipment, personnel, safety/handling, storage and energy.
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