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Highly Potent Active Pharmaceutical Ingredients

HPAPI, HORMONE, AND CYTOTOXIC HANDLING CAPABILITIES

Catalent is the #1 Drug Development, Delivery and Supply Partner for the global pharmaceutical and biotech industries.

With over 20 years of experience in potent handling and more than 80 years in pharmaceutical delivery solutions, Catalent offers integrated analytical, development, manufacturing, and clinical supply solutions for highly potent products.

Catalent’s long history of expertise in handling high potent molecules includes more than 300 Category 3 & 4 compounds across 12 sites in the global Catalent network, including hormones and cytotoxics. Catalent has also recently acquired a state-of-the-art facility in Greenville, N.C. which features fit-for-scale capacity with extensive potent handling capabilities.

TECHNOLOGYPOTENT (10 to 1UG/M3-OEL)HIGHLY POTENT (1UG/M3 or less)CYTOSTATICCYTOTOXICHORMONESDEA I-V
TECHNOLOGY
POTENT (10 to 1UG/M3-OEL)
HIGHLY POTENT (1UG/M3 or less)
CYTOSTATIC
CYTOTOXIC
HORMONES
DEA I-V
Oral Solids
Yes
Yes
Yes
No
No
Yes
Softgel
Yes
Yes
Yes
Yes
Yes
Yes
Zydis
Yes
Yes
Yes
No
No
Yes
Micronization
Yes
Yes
Yes
Yes
No
Yes
Spray Drying
Yes
Yes
No
No
No
No
Analytical
Yes
Yes
Yes
Yes
Yes
Yes
Development
Yes
Yes
Yes
Yes
Yes
Yes
Manufacturing
Yes
Yes
Yes
Yes
Yes
Yes
Clinical Packaging
Yes
Yes
Yes
Yes
Yes
Yes
Clinical Supply
Yes
Yes
Yes
Yes
Yes
Yes

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HIGHLY POTENT SOLUTIONS OVERVIEW

From API optimization, particle size optimization and formulation services, to drug delivery technology and final dose form design services, Catalent can help you at the earliest stages of the drug development process and provide end-to-end solutions to accelerate your programs to clinic and to market, utilizing our broadest expertise, best technologies and rigorous science.

  • Global supply chain expertise
    • Development
    • Analytical services
    • Delivery technologies
    • Clinical and commercial manufacturing
    • Packaging services
    • Clinical storage and distribution
  • Highly potent, hormonal, cytotoxic compounds
  • Multiple oral dose form technologies and services
  • Robust controls for special handling and containment
    • Engineering and PPE controls
    • Comprehensive risk assessment processes
    • Highly-trained and experienced personnel
    • Expertise in special handling protocols
  • Controlled substance handling (DEA I-V)

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BROAD RANGE OF ORAL TECHNOLOGIES

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EXTENSIVE SUITE OF ORAL MANUFACTURING CAPABILITIES

  • Compression and encapsulation
  • Extrusion/spheronization
  • Blending and milling
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    FACILITIES WITH POTENT HANDLING CAPABILITIES

    Our high potent handling facilities have strong track records for both quality and regulatory compliance.

    Oral Solids Development and Manufacturing

    Softgel Technologies

    Stand-Alone Analytical Services

    Clinical Supply

    Get an up-close look at these sites and more, explore Catalent’s 360⁰ virtual tours.

    All molecules have a challenge. We have a solution.  For an expert consultation of how we can assist with your highly potent molecule challenges contact us and an expert will get back to you shortly.