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