We have had more than 46 product approvals in just 25 years. Pii supports commercial manufacturing services for customers, ranging from orphan drugs to complex AB-rated generics and 503B compounding for parenteral, topical, and oral pharmaceutical drug products.
COMPREHENSIVE CGMP PHARMA MANUFACTURING
Your CDMO Partner for Turnkey Pharmaceutical cGMP 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, which is matched by our well-designed facilities, proven technologies, broad expertise, and knowledgeable personnel.
In the 25-plus years that Pii has provided contract manufacturing and packaging services, we have been approved to manufacture more than 50 commercial products, many of those developed here at Pii. In this short time, Pii has gained the trust of US and international regulatory bodies, as well as large and small pharmaceutical and biotech companies. Our current and near-term commercial product portfolio includes NDAs, ANDAs, NADAs, ANADAs, and support for new site transfers to our US-based manufacturing facilities.
- Our customers include virtual as well as fully integrated global pharmaceutical companies, orphan drug companies, and small- and large-scale biotechs. Dosage forms include oral, parenteral, and topical drug products.
- Our parenteral manufacturing capabilities include small- and large-scale vial filling for liquids, lyophilization, pre-filled syringes, and cartridges using our Robotic AST GENiSYS® R, Groninger, M&O Perry, and Bosch filling lines and utilizing single-use technologies, as well as Millrock lyophilized and Fedegari autoclaves.
- Our oral manufacturing capabilities include granulation (both aqueous and solvent), blending, roller compaction, soft gels, tableting, encapsulation, aqueous and solvent pan coating, fluid bed processing and coating, liquids/suspensions, and media milling.
- Our packaging capabilities include bottles, blisters, labeling, cartooning, and serialization.
- We manufacture and package oral and parenteral products for the US and EU markets, while also providing full analytical and microbiology support to release products and support stability studies.
From Safety to Compliance to Accuracy and Tracking
- Inspected and approved by the FDA, EMA, and other international regulatory bodies
- Currently approved to manufacture over 50 commercial products
- US-based facilities include more than 70 cGMP production suites
- Capabilities for handling hormones, potent and cytotoxic compounds, and DEA-controlled substances
- 30,000 sq. ft. of warehousing space to support short-term commercial storage
- DEA vault and cold storage
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.