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High Potency APIs (HPAPIs)

Piramal Pharma Solutions now offers High Potency API (HPAPI) services following its acquisition of Ash Stevens, a leader in HPAPI development and cGMP manufacture. Our FDA licensed cGMP facility located in Riverview, USA offers a full range of scale and containment options for high potency APIs.

Potent molecule manufacturing is a complex process, and long-term experience, state-of-the-art facilities, robust operations and impeccable safety records make us a preferred partner for HPAPI projects.

Services Offered:

  • Development and Manufacture of High Potency APIs
    • Process Research, Development, Optimization, and Scale-Up
    • cGMP Manufacturing for Clinical Trials
    • Commercial HPAPI Manufacturing
  • Comprehensive Analytical and Regulatory Services to Support Early-Stage Development Through Registration and Commercial Manufacturing
  • Impurity Identification, Characterization, and Synthesis
  • Solid State Characterization (XRPD, DSC, TGA and PSD)
  • Quality by Design (QbD) Services Consistent with ICH Guidelines
  • Reference Standard Qualification and Stability Studies
  • Safety/Hazard Assessment
    • Process Safety Team – Project and Scale-up Safety Assessments
    • Hazard Assessment Laboratory Instrumentation: RC-1, DSC, TSUe
  • Documentation for Regulatory Submissions (IND, NDA, DMF, CTD)

Why choose us?

  • Longstanding provider of contract research services to the National Institutes of Health (NIH) and the National Cancer Institute (NCI)
  • State-of-the-art High Potency API Manufacturing Suite with Airlocks and Barrier Isolation Systems Areas
  • Scaled Rosenmund Filter Dryer Capacity with Glovebox Technology to Facilitate Contained Isolations from Laboratory to Plant Scale
  • Successful Global Regulatory Inspection History (US FDA, UK MHRA/ EU, GMP, PMDA Japan, MFDS Korea, TGA Australia & Mexican Ministry of Health)
  • Multiple Awards from SOCMA’s ChemStewards® Program for Continuous Improvement in EHS&S Operations

Location

Riverview, USA

For more information visit: http://www.ashstevens.com/

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