A global leader with over five decades of experience, our FDA approved cGMP state-of-the-art facility of Piramal Pharma Solutions located in Riverview, MI (USA) offers High Potency API (HPAPI) services, and a full range of scale and containment options.

Specialized Capabilities

  • Up to 4,000 L Glass Lined Reaction Vessels with a Temperature Range of -70°C to 200°C
  • Product Isolation Capabilities: Extraction, Filtration, Centrifugation, and Distillation
  • Drying/finishing facility: Scaled Rosenmund Filter Dryers with Glovebox Technology, Forced Air & Vacuum Drying Ovens, and Class 10,000 Clean Suites
  • Track record of successful launches, robust engineering controls and a stellar safety record make us a preferred 'Partner of Choice' for high potency projects

High potent API manufacturing suites with airlocks and barrier isolation systems (OELs ≥ 20ng/m3 at Kilo-lab scale)

Services Offered

  • Development and manufacture of commercial High Potent API compounds
    • Process Research, Development, Optimization and Scale-Up
    • cGMP Manufacturing for Clinical Trials
  • Comprehensive analytical and regulatory services to support early-stage development
  • Impurity Identification, Characterization, and Synthesis
  • Solid-State Characterization (XRPD, DSC, TGA and PSD)
  • Quality by Design (QbD) Services Consistent with ICH Guidelines
  • Process Safety Team – Project and Scale-up Safety Assessments
  • Safety/Hazard identification and risk assessments
  • Hazard Assessment Laboratory Instrumentation: RC-1, DSC, TSU, ARC
  • Documentation for Regulatory Submissions (IND, NDA, DMF, CTD)

Salient features

  • 15 US FDA Manufacturing Approvals (NCEs)
  • Significant experience in fast track approvals and orphan diseases
  • Successful global regulatory inspection history: US FDA, EU (QPs), Health Canada, PMDA Japan, MFDS Korea, TGA Australia, COFEPRIS Mexico, and Russia among others
  • A longstanding provider of contract research services to the National Institutes of Health (NIH) and the National Cancer Institute (NCI)