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Drug Product Manufacturing

cGMP manufacturing of drug product through phase II. Excellence in manufacturing that ensures quality products.

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Overview

Capable of manufacturing solid, liquid, and semi-solid dosage forms, BioDuro’s Drug Product Manufacturing team provides a comprehensive service for clinical trial material preparation in support of Phase 0 to Phase II studies. Our contract pharmaceutical manufacturing services are cGMP compliant and include established clinical trial material management SOPs with QA oversight.  Our highly trained manufacturing team is dedicated to on time delivery of high quality product. We believe that having a well trained and experienced manufacturing staff will streamline manufacturing efficiency and increase process reliability, positively impacting project timelines. Whatever your project, our expert staff will ensure its successful completion.

BioDuro Advantage

  • Flexible manufacturing scheduling
  • Well trained and experienced manufacturing operators
  • Full project management transparency during production
  • Strong QA oversight

Dosage Forms

  • Tablets
    • Immediate release tablets
    • Coated tablets
    • Matrix tablets
  • Capsules
    • Blend in capsules
    • Tablets in capsules
    • Liquid in capsules
    • API in a capsule (Xcelodose®)
    • Pellets in capsule
  • Beads, pellet and granules
    • Coated pellets/beads
    • Controlled release beads
  • Oral liquids
    • Liquids
    • Suspensions
    • Lipid-based delivery systems
  • Topical
    • Creams
    • Gels
    • Ointments

Process Technologies

  • Hot Melt Extrusion
  • Spray Dried Dispersion
  • Roller compaction
  • Wet Granulation
  • Milling
  • Blending
  • Tablet Compression
  • Encapsulation
  • Pan Coating
  • Wurster coating
  • Spray granulation
  • Fluid bed drying

Packaging Capabilities

  • Drum storage
  • Induction Sealed Bottles (Child Resistant Closures)
  • Automated Tablet/Capsule Counting
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