Bring Your Drug to the U.S. Market Without Packaging Risk

Key-Pak® and Key-Pak® Plus

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Produced with renewable, printable paperboard and available in a variety of sizes and formats. Fold-out panel for customization and additional content Calendarized blister reminds patients to take their medication. Important reminders and branding stay with the inner card for the duration of therapy. Offers versatility for a wide range of medications. Sturdy, protective outer carton. Child-resistant, senior-friendly packaging.

Supplying India-based
pharma with pre-qualified
CR packaging for over a decade

To learn more or to request a free sample of Key-Pak® or Key-Pak® Plus, CLICK HERE.

Key-Pak® and Key-Pak® Plus are innovative and versatile paperboard blister pack solutions which can be designed for standard tablets and capsules or for challenging dosage forms, including friable tablets, gel caps, and liquid-filled products. Their unique functionality make them ideal for complex dosing situations such as titration regimens and multi-pill dosing. With their large billboard space, Key-Pak® and Key-Pak® Plus offer clear, easy-to-read instructions, ensuring better patient compliance to dosing regimens.

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De-Risk Your ANDA Packaging vs Dose Packs

Discover how Key-Pak can help you get faster approval while
reducing risk vs traditional dose pack formats

10 Key Benefits of the Key-Pak Blister Wallet:

  1. CR-equivalent blister wallet solution
  2. Supports FDA submissions
  3. Reduces regulatory and commercialization risk
  4. Replicates RLD packaging strategy
    (dose pack alternative)
  5. Leverages CR equivalence data
    (avoid re-testing in many cases)
  1. Proven in U.S. commercial launches
  2. Documented FDA acceptance vs RLD
  3. Minimizes risk of delays
  4. Meets CR testing requirements
  5. Keystone acts as your regulatory partner, not just a packaging supplier
Key-Pak® Child Resistant Packaging
Key-Pak® Child Resistant Packaging

Dose Pack vs Key-Pak

Worried that Key-Pak is not in line with Reference Listed Drug (RLD)?

Rest assured…

  • Key-Pak Plus is structurally and functionally similar to traditional dose pack formats
  • CR functionality is achieved at the dose level
  • Alternative packaging is acceptable with proper justification
  • Keystone supports equivalence strategy and documentation
  • Key-Pak has been used by pharmaceutical manufacturers across the globe for decades

Key-Pak is Trusted by Indian Pharmaceutical Manufacturers

  • Keystone has experience supporting U.S. market submissions from India
  • We have familiarity with FDA expectations
  • Key-Pak is scalable for large-scale commercial supply
  • Key-Pak is compatible with standard blister tooling and processes

Key-Pak Offers Cost
and Operational
Advantages

  • Key-Pak offers a lower total system cost vs  multi-component formats
  • The package is simple to assemble
  • It offers standard heat-seal compatibility
  • Streamlined scalability to meet growing demand

Key-Pak Delivers Child Resistance Regulatory Compliance

  • Meets U.S. CPSC standards
  • Supports equivalence arguments
  • Enables regulatory alignment