Riverview, USA

With over 50 years of experience, our state-of the-art FDA approved cGMP facility in Riverview, USA, can support your HPAPI needs from early development to commercial manufacture. The site holds an impeccable safety record and has successfully launched several billion dollar NCEs and orphan drugs with numerous fast track approvals.

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Services Offered

  • Process Research FTEs, Development, Optimization and Scale-Up
  • cGMP API Manufacturing for Clinical Trials
  • Commercial API Manufacturing (including High Potency APIs)
  • Safety/Hazard Assessment
  • Impurity Identification, Characterization, and Synthesis
  • Solid State Characterization (XRPD, DSC, TGA and PSD)
  • Analytical Method Development and Validation

Site capabilities

  • Comprehensive API Development and Manufacturing Capabilities from Gram Scale to Hundreds of Kilos
  • 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, Distillation
  • Drying/Finishing Facility : Rosenmund Filter Dryers, Forced Air & Vacuum Drying Ovens, Class 10,000 Clean Suites
  • State-of-the-Art High Potency API Manufacturing Suite with Airlocks and Barrier Isolation System
  • Scaled Rosenmund Filter Dryer Capacity with Glovebox Technology to Facilitate Contained Isolations from Laboratory to Plant Scale
  • Reactor Bays Equipped with Necessary Engineering and Process Controls to Safely Handle HPAPIs at Large Scale

Salient Features

  • 14 US FDA Manufacturing Approvals (NCEs)
  • Significant experience in Fast Track Approvals and orphan diseases
  • Successful Global Regulatory Inspection History; US FDA, EMA & UK MHRA, Health Canada, PMDA Japan, MFDS Korea, TGA Australia & COFEPRIS Mexico among others
  • Recognised as a Global top 10 % CMO
      Multiple CMO Leadership Awards, Recognized in All Five Categories plus All Eight Individual Attribute Categories (2010 – 2017)
      Leader in SOCMA's ChemStewards® Program for Continuous Improvement in EHS&S Operations

Contact Details

Piramal Pharma Solutions

18655 Krause St,

Riverview, MI 48193

Contact: +1 734 282 3370


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OUR LOCATIONS

With a versatile, fully integrated network of development and manufacturing sites across North America, Europe, and Asia. Learn more about how we can serve your needs locally, wherever you are

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