GMP Manufacturing

Xcelience specializes in Phase I-III GMP manufacturing for oral solid clinical trial needs. We provide a suite of services for a variety of drug manufacturing and small-scale commercial manufacturing requirements, including tablets and capsules, API in capsule, liquids in capsule, and non-sterile liquids.

Our GMP manufacturing capabilities include:

  • Tablets
  • Capsules
  • Reference product blinding and placebo
  • API into capsule
  • Liquid in capsule
  • Non-sterile liquid

Our GMP processes include:

  • Dispersions
  • Compounding
  • Blending
  • Spray drying
  • Wet and dry granulations
  • Direct compression
  • High shear granulation
  • Fluid bed coating and drying
  • Milling and micronizing
  • Clinical Trial Material manufacturing
  • Process optimization using Quality by Design approach (QbD)
  • Analytical methods development
  • Cleaning method development and verification
  • Stability
  • Clinical packaging and labeling
  • Clinical trial material storage and distribution
  • Small-scale commercial manufacturing