Piramal Pharma Solutions (PPS) stands at the forefront of High Potency Active Pharmaceutical Ingredient (HPAPI) manufacturing, offering specialized capabilities that ensure safety, precision, and compliance throughout the drug development lifecycle.
State-of-the-Art HPAPI Facilities
At the heart of PPS's HPAPI services is the Riverview facility in Michigan, USA. With over 60 years of experience in handling and manufacturing highly potent compounds, the facility is equipped with:
- High potency manufacturing suites featuring airlocks and barrier isolation systems.
- Capability to handle compounds with Occupational Exposure Limits (OEL) as low as 10 ng/m³.
- Reactor volumes up to 50 liters and handling capacities up to 2 kg.
These features ensure precise and efficient production processes, adhering to current Good Manufacturing Practices (cGMP).
Comprehensive HPAPI Services
PPS offers end-to-end solutions for HPAPI development and manufacturing, including:
- Process Development: From route scouting to analytical development, ensuring optimal synthesis pathways.
- Scale-Up and Tech Transfer: Seamless transition from lab-scale to commercial manufacturing.
- Clinical and Commercial Supply: Flexible production scales to meet varying project needs.
- Regulatory Compliance: Facilities inspected and approved by global regulatory bodies, including the US FDA, Health Canada, and PMDA Japan.
Integrated Global Network
PPS's global footprint includes facilities across North America, Europe, and Asia, enabling:
- Access to a diverse range of specialized services, including peptide and hormonal API manufacturing.
- Efficient project management through integrated services and collaborative teams.
- Rapid response to market demands and regulatory requirements.
Commitment to Quality and Patient Centricity
Piramal Pharma Solutions is dedicated to delivering high-quality HPAPI manufacturing services that prioritize patient safety and therapeutic efficacy. Their commitment to operational excellence and continuous improvement ensures that clients receive reliable and innovative solutions tailored to their specific needs.
For more information on PPS's HPAPI capabilities, visit their official page: High Potency API (HPAPI) & Peptide API Manufacturing Services.
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