Clinical Manufacturing

cGMP manufacturing through phase I, II & III
Direct API fill into capsules (using Xcelodose 600)
Dosage form preparation and blinding
Open and blinded clinical packaging and labeling
Semi-automated and fully automated overencapsulation
Wet and dry granulation
Tableting
Coating: beads and tablets
Encapsulation for powders, granules, tablets and mixed combinations
Schedule II - V control drug manufacturing

Formulation Evaluation
  • Content uniformity evaluation
  • Dissolution testing
  • Stability assessment
Regulatory Support
  • SUPAC application support
  • GMP/FDA/ICH guidance
  • Product development strategies
Analytical Services
  • HPLC based
  • Full ICH stability conditions
  • Dissolution testing
Clinical Manufacturing
  • cGMP manufacturing
  • Direct API fill into capsules
  • Dosage form preparation and blinding




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