COVID-19

Dear Partners,

Necessitated by the unprecedented situation created by Covid-19, several industry events and tradeshows across the world have been postponed or stand cancelled. While we were looking forward to meet you, we at Piramal Pharma Solutions have had to take several precautionary measures to protect both our employees and customers, worldwide.

As we move forward in these extraordinary times, we want to assure you that that we are operational by taking the right safety measures and abundant precautions to ensure that we continue to support you and your patients.

While all of us are working remotely for now, you can schedule a discussion with us and we would be glad to help ensure you meet your pharmaceutical development and supply needs and thereby, your clinical and commercial timelines.

Please feel free to reach out to us at:
Stuart.Needleman@piramal.com

Our best wishes to colleagues, friends and family.

Best Regards,
Piramal Pharma Solutions

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Riverview

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
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