We have more than 46 product approvals in 25 years of commercial manufacturing service for our customers ranging from orphan drugs to complex AB-rated generics and 503B compounding outsourcing for parenteral and oral products.
COMPREHENSIVE cGMP PHARMA MANUFACTURING
Your CDMO Partner for Turnkey Pharmaceutical cGMP Manufacturing Solutions
At Pii, quality is the foundation of everything we do. We strive to be a reliable commercial manufacturing and packaging partner by building exceptional quality systems matched by our well-designed facilities, proven technologies, broad expertise, and knowledgeable personnel.
In the 25 years that Pii has provided contract manufacturing and packaging services, we have been approved to manufacture more than 46 commercial products, many of those developed here at Pii. In this short time, Pii has gained the trust of U.S. and international regulatory bodies, as well as large and small pharmaceutical companies. Our current and near-term commercial product portfolio includes NDAs, site transfers to US-based manufacturing facilities, and ANDAs.
- Our customers include fully integrated global pharmaceutical companies and virtual biotechs. Dosage forms include oral, parenteral, injectable and aseptic products.
- Our parenteral manufacturing capabilities include vial filling for liquids and lyophilization, syringes and cartridges using our AST, Groninger, M&O Perry and Bosch filling lines utilizing single-use technologies, as well as, lyophilizers from Millrock and autoclave from Fedegari.
- Our oral manufacturing capabilities include granulating (aqueous and solvent), blending, tableting, encapsulation, pan coating, fluid bed coating and media milling.
- Our packaging capabilities include bottles, blisters, labeling, cartoning and serialization.
- We manufacture, package, warehouse and distribute oral and parenteral products for the US 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 46 commercial products
- More than 70 cGMP production suites
- Capabilities for handling hormones, potent and cytotoxic compounds and DEA-controlled substances
- 30,000 sq-ft warehousing space
Regulatory Integrated Support - Ensuring Compliance at Every Stage
Pii’s commercial manufacturing services are supported by full analytical services, quality assurance, and project management. We work with our clients every step of the way to ensure seamless manufacturing from receipt of API to product release.
With more than two decades of commercial manufacturing experience, Pii brings you the expertise and capabilities you need to ensure your reliable commercial supply.