Product Lifecycle Experience

With a fully integrated pharmaceutical operation in the United States, Purdue offers capabilities and expertise at all stages that transform an idea into a new healthcare product. When you partner with Purdue, your company benefits from experience that spans the entire product lifecycle.

Product Lifecycle

  • Intellectual Property (IP)—Purdue has a track record of successfully defending IP rights with highly effective results
  • Development—Purdue has developed market-leader pharmaceutical products that have earned FDA approval and become therapies prescribed or recommended by healthcare professionals for patient care
  • Regulatory Affairs—With decades of experience with controlled substances for medications that help patients manage chronic pain, Purdue has acquired the strong regulatory affairs expertise that is needed to ensure compliance with the strict safety requirements of government agencies, such as the U.S. Food and Drug Administration (FDA) and the U.S. Drug Enforcement Administration (DEA)
  • Manufacturing—Our goal is to manufacture products that meet and/or exceed current Good Manufacturing Practices (cGMP) with the highest levels of customer service
  • Commercialization—Purdue’s Marketing organization has the critical mass and skills to commercialize new products quickly and effectively
  • Distribution—Purdue can offer partners an optimized distribution strategy and an extensive distribution operation

Quality, a Competitive Advantage for Purdue, Enhances the Approvability of New Products

Our track record in quality is a competitive advantage for Purdue, enhancing the approvability of new products and ensuring a continuing supply of healthcare products to the market. The reach of the quality organization extends from discovery through manufacturing, commercialization, and distribution.

The Purdue Quality Organization provides a foundation for compliance throughout the company, setting the standards and policies that govern the manufacturing and supply of our products. Quality Assurance (QA) and Quality Control (QC) colleagues work side by side with manufacturing to ensure that all medicines are produced to the highest standards and precise specifications for our customers. From raw material and finished product testing to ongoing stability studies and analysis, our QC Laboratories ensure that products meet quality specifications. Counterparts in QA provide guidance on procedures and policies and conduct audits to ensure that cGMP and Good Laboratory Practices (GLP) are maintained in our facilities and those of our suppliers.

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Purdue Ensures Quality in Manufacturing, Supply Chain, and Distribution Through World-Class Processes

Purdue takes great pride in fostering a culture of compliance and continuous improvement throughout our manufacturing and distribution operations. Our culture combines teamwork, knowledge, technology, and state-of-the-art facilities to create an effective and efficient supply chain for each product. Using a fully integrated supply chain, we build strategic alliances with quality suppliers of raw materials and components, and with contract service providers to reliably produce and distribute our products.

Manufacturing is located in our modern solid-dose manufacturing facilities in North Carolina. Purdue uses technology platforms such as SAP, POMS, LIMS, and AIDC to ensure a robust and secure supply chain for products. Purdue was one of the first pharmaceutical companies to provide fully integrated anti-counterfeit packaging to enable authentication and traceability of our products throughout the distribution chain.

For example, unique ID tags and color-shifting ink are integrated into the packaging for OxyContin® (oxycodone HCl extended-release tablets) CII.

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Partnering With Purdue Connects Your Company to Our Network

Marketing—Develops and defines the objectives and positioning strategies for Purdue brands. This team ensures that Purdue maintains its leadership position within specific therapeutic areas and successfully brings new products to market by collaborating with Licensing & Business Development to explore and evaluate new product possibilities.

Market Access—Responsible for gaining and maintaining formulary coverage for all Purdue products in various market segments, including managed care, long-term care, Medicaid, and Medicare markets. This group maintains strong working relationships with decision makers at managed care organizations (MCOs), group purchasing organizations (GPOs), national retailers and pharmacies, Department of Veteran’s Affairs, Department of Defense, Medicare, and Medicaid.