Working with our customers, we have supported more than 50 product approvals in our 25-plus years of commercial manufacturing service. Products range from ANDAs, NDAs and orphan drugs across a range of complex parenteral and oral drugs.
COMPREHENSIVE GMP PHARMA MANUFACTURING
Your CDMO Partner for Turnkey Pharmaceutical GMP Manufacturing Solutions
At Pii, quality is at the foundation of everything we do. We strive to be a reliable commercial manufacturing and packaging partner by building exceptional quality systems as the foundation for our well-designed facilities, proven technologies, broad scientific expertise, and Pharmaceutics Know-HowTM.
In Pii’s 25-plus years of providing contract manufacturing and packaging services, we have been approved to manufacture more than 50 commercial products, many of those developed by our own experienced R&D team. During our years of collaborating with customers, Pii has gained the trust of small and large U.S. and international pharmaceutical and biotech companies. Working with regulatory authorities, we’ve hosted multiple product PAIs and inspections to support our customers’ filings to get them to final approval. Many of the NDAs and orphan drug products have been marketed to treat very sick patients in need.
- Our customer include fully integrated global pharmaceutical companies, biotech, virtual, and orphan drug companies. Dosage forms include soft gels, tablets, capsules, suspensions, oral liquids, and injectable products.
- Our parenteral manufacturing capabilities include compounding and filling into vials, syringes, and cartridges, as well as lyophilization services. Pii’s aseptic suites house our new Robotic AST GENiSYS® R - line, our Groninger syringe line, M&O Perry and larger scale Bosch vial filling lines, and a Millrock lyophilizer. We provide fill-finish, aseptic filtration, and terminal sterilization.
- Pii’s oral manufacturing capabilities include high and low sheer granulation (aqueous and solvent), blending, tableting, encapsulation, aqueous and solvent coating, fluid bed processing, soft gel production, and media milling.
- Our packaging capabilities include bottles, blisters, labeling, secondary cartons and serialization.
- We support commercial manufacturing, packaging, serialization, and labeling for oral and parenteral products for the U.S. and EU markets.
From Safety to Compliance to Accuracy and Tracking
- Inspected and approved by the FDA, EMA, and other international regulatory bodies
- Currently approved to manufacture more than 50 commercial products
- Facilities with flexible capacity based on our 70 GMP production suites
- Capabilities for handling hormones, potent and cytotoxic compounds, and DEA-controlled substances
- Fully equipped analytical and micro laboratories for product testing and final release as well as stability support
Regulatory Integrated Support - Ensuring Compliance at Every Stage
Pii’s commercial manufacturing services are supported by our quality management team as well as dedicated project managers who work with our clients every step of the way to ensure seamless quality manufacturing from receipt of API to product release.
With almost three decades of commercial manufacturing experience, Pii brings you the quality, expertise, and capabilities you need to ensure your reliable commercial supply chain.