PII

Technology Transfer and Scale-Up

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Commercial Manufacturing

More than 40 commercial products in just 20 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 20 years that Pii has provided contract manufacturing services, we have been approved to manufacture more than 40 commercial products, many of those developed here at Pii. In this short time, Pii has gained the trust of US and international regulatory bodies and large and small pharmaceutical companies. Our current and near-term commercial product portfolio include NDAs, site transfers, and ANDAs.

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

Capabilities:

  • Oral (tablets, capsules, powders and liquids)
  • Soft gel and liquid-fill 2 piece hardshell capsules
  • Aseptic: Vials, Syringes, and Lyophilized products
  • Topical: Creams, Ointments and Gels
  • Inhaled / Respiratory Drug Delivery: DPIs and pMDIs

With core competency in the development and manufacture of challenging compounds and complex dosage forms, Pii experiences and capabilities including:

  • Controlled Substances (DEA Schedules I-V)
  • Hormones, Potent & Cytotoxic Compounds
  • Controlled Release Formulations, including Tablet-in-Tablet & Bi-layer Tablets
  • Advanced Drug Delivery Systems: Solid Dispersions, Nanotechnology & Lipid Delivery

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We work hard to meet your specific needs – whether it’s a challenging compound, niche product, or conventional dosage form. Our equipment capacities range from small scale orphan drugs to batch sizes of more than 1,200 kilograms.   We match our capabilities to your specific project requirements to ensure long-term success and profitability.

Experience:

  • Inspected and approved by the FDA, EMA and other international regulatory bodies
  • Currently approved to manufacture 40 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 (including QP Release Services) and project management.  We work with our clients every step of the way to ensure seamless manufacture from receipt of API to product release. With more than two decades of commercial manufacturing experience, Pii brings you the experience and capabilities you need to ensure your commercial supply. Read More »

 

 

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