Case Study II : Process Development & Contract Manufacturing

Project Scope

Develop a commercially viable Patent non-infringing process to support commercial Launch.


Customer

Mid size Pharma company, MENA region


Scope & Deliverables

  • Development & Optimization of Non Infringing Process
  • Lab scale Process validation & stability studies
  • Analytical method development & validations
  • Commercial scale up & process validation
  • On time supply of Product for Exhibit batches
  • DMF subAbout Us in CTD format with One year stability data


Value addition

  • Patent Non-Infringing route
  • Handholding for regulatory filing & compliance


Customer Delight

  • Project delivered in 15 months v/s the agreed timelines of 16 months
  • Orders by customer for commercial supplies of 3.5MT/yr
  • YOY cost reduction achieved


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