Our Riverview MI, USA facility is a USFDA, Health Canada, EU, Mexico, Korea, Australia, and Russia inspected site which can support your Drug Substance (API) needs. The site also has extensive experience in safely delivering high potency APIs (HPAPIs), and has advanced several HPAPIs from early development to commercial manufacture.

Location Address:

Piramal Pharma Solutions, 18655 Krause St, Riverview, MI 48193, USA

Contact: +1 734 282 3370

Site 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 capabilities: sealed Rosenmund filter dryers with glovebox technology, forced air & vacuum drying ovens, and class 10,000 clean suites
  • High potency manufacturing suites with airlocks and barrier isolation systems (OELs ≥20 ng/m3 at kilo-lab scale)
  • Reactor bays equipped for large scale HPAPIs

Featured Services

  • Process research FTEs, development, optimization, and scale-up
  • Commercial API manufacturing (including high potency APIs)
  • Safety/hazard assessments
  • Impurity identification, characterization, and synthesis
  • Solid-state characterization (XRPD, DSC, TGA, and PSD)
  • Analytical method development and qualification/validation

Salient Features

  • 15 US FDA manufacturing approvals (NCEs)
  • Significant experience in fast track approvals, breakthrough status, and orphan diseases
Virtual Tour
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