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.
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, optimisation and scale-up
- Commercial API manufacturing (including high potency APIs)
- Safety/hazard assessments
- Impurity identification, characterisation and synthesis
- Solid-state characterisation (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
Location address:
Piramal Pharma Solutions, 18655 Krause St, Riverview, MI 48193, USA
Contact: +1 734 282 3370
