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:

Our best wishes to colleagues, friends and family.

Best Regards,
Piramal Pharma Solutions

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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)