Contract Manufacturing

Neos Therapeutics is an established provider of turn-key contract manufacturing services utilizing our 100,000 square foot, state-of-the-art, cGMP facility. Our dedicated Contract Manufacturing team provides product development support for a wide range of oral dosage forms, on projects ranging from pre-clinical through manufacturing and packaging of finished product.

Neos will tailor a development program to fit your specific requirements. We pride ourselves on providing high quality, creative and timely solutions to meet your drug development and manufacturing needs.

Our Specialized Services include:

Pharmaceutical Development and Manufacturing Capabilities

  • Rx and OTC
  • Time-released formulations: IR, SR, CR and combination release profiles
  • Liquids: oral solutions, suspensions and sprays
  • Tablets and Capsules
  • Unique Dosage Forms: oral disintegrating tablets and chewable tablets
  • DEA Licensed for Schedule II – V controlled substances

Research & Development

  • Small molecule formulations
  • Reverse formulations
  • Technical transfers
  • Drug delivery development
  • Test method development
  • Dynamic Parallel Matrix Development System

Quality Assurance / Quality Control / Regulatory

  • FDA cGMP compliant
  • Full service analytical laboratories
        Raw material, microbiology, finished product, stability testing
        HPLCs, GC, dissolution baths, stability chambers
  • Engineering and validation services (method, process and cleaning)
  • Pre-clinical and clinical support
  • Regulatory strategies and submissions: IND, NDA, 505(b)(2), ANDA

Manufacturing

  • Milling and blending
  • Liquid mixing and emulsification
  • Wet granulation, hi-shear granulation, oven drying and fluid bed drying
  • Coating
  • Tablet compression
  • Encapsulation with powder, mini-tabs, beads or combination with check-weighing

Packaging

  • Solid dose bulk or bottle packaging
  • Positive displacement or pump liquid filling
  • Glass or plastic bottles from 50ml to 1000ml
  • Bottle labeling, neck-banding and body-banding

Neos Therapeutics is ready to deploy our experienced team, science and systems to ensure success for your next contract manufacturing project.

Contact Neos Therapeutics at 972-408-1300 today!