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Commercial Manufacturing

More than 45+ commercial approvals in 25 years of commercial manufacturing service

 

At Pii, quality is the foundation of everything we do.  We strive to be a reliable commercial manufacturing partner by building exceptional quality systems matched by our well-designed facilities, broad expertise, and knowledgeable personnel. In the 25 years that Pii has provided contract manufacturing 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 US and international regulatory bodies, as well as large and small pharmaceutical companies. Our current and near-term commercial product portfolio include NDAs, NADAs, site transfers, ANDAs and ANADAs.  

 

Clients include fully integrated pharmaceutical companies and virtual biotechs.  Dosage forms include oral, topical and injectable products.

 

Experience:

  • 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 ft warehousing space

 

Robust Facilities & Integrated Support

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 commercial supply.