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Early Phase API

Early Phase API

We have been providing API development services for over 3 decades to clients from our network of development labs, kilo labs and pilot plants across the globe. Our synergistic model of delivery across Canada, India and the UK gives our clients higher speed of delivery, proximity to markets as well as flexible solutions. We have a team of more than 100 scientists across geographies supported by an infrastructure of fume-hoods, kilo labs and GMP and non-GMP pilot production areas.

Services Offered

  • Development Services
  • Analytical Services
  • Additional Services

Development services

  • Process development for pre-clinical and clinical supplies
  • Process / route selection
  • Pre-clinical (non-GMP and GMP) manufacturing
  • Manufacturing support
  • Process engineering
  • Solvent CC reduction
  • Yield improvement
  • Capacity de-bottlenecking

Analytical services

  • Analytical method validation and method transfer
  • Reference standard qualification
  • Testing of raw materials
  • Intermediates and finished product testing.
  • Third party sample analysis
  • In process checks, cleaning verification
  • Wet Chemistry and Compendial tests
  • Stability studies as per ICH guidelines
  • Stability chambers / freezers

Additional services

  • Impurities and Reference Standards
  • Sample preparation for toxicity studies
  • Critical parameter assessment
  • Documentation