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HPAPI
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
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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)