OVERVIEW

Catalent Benefits      Catalent Services

Catalent announces approval of the first generic MDI since the removal of CFC-based inhalers from the market. Catalent is proud to provide the development and manufacturing services necessary to make this product a reality.

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CATALENT BENEFITS

• Experience in commercializing HFA-based MDIs
• End-to-end development and manufacturing services to take your API from particle to patient
  • Particle size reduction
  • Material characterization
  • Formulation feasibility
  • Product development
  • Process development
  • Clinical-scale manufacture
  • Clinical-supply services
  • Commercial-scale manufacture
  • Packaging QC / Release testing
• Deep inhalation product development expertise
  • Decades of inhalation product development experience
  • Expertise in Quality-by-Design
  • Engaged with and influential among inhalation expert groups
  • Integrated preformulation and formulation services
  • Development across all common dosage forms (MDI, Nebules, Nasal, DPI)
• Reliably supplied with an exemplary regulatory track record
  • Global project and supply chain management to ensure high-quality delivery
  • Thorough understanding of U.S. and European regulatory requirements for both generic and new chemical entity drug-device combination products
  • Assistance in defining submission strategies on Chemistry, Manufacturing and Controls (CMC)

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CATALENT SERVICES

• Dosage form development
  • Formulation selection and optimization
  • Characterization of aerosols
  • Device performance
  • Pump and container selection
  • cGMP compliance
• Product testing
  • Manufacturing validation support (process and cleaning validation)
  • Release and finished product testing
  • Particle size distribution
    • Next Generation Pharmaceutical Impactor (NGI)
    • Anderson Cascade Impactor (ACI)
  • MDI plume geometry
  • Spray and droplet analysis
  • Automated actuators
  • Thermogravimetric analysis
  • Drug and delivery assays
  • Stability studies (ICH and custom conditions)
  • Structural elucidation of drug-related impurities and degradation products
  • Extractables and leachables studies
• Clinical and commercial manufacturing
  • Complete clinical trials materials preparation in support of Phase I – IV studies and provide seamless technology transfer to our commercial manufacturing facilities:
    • Class 10,000 space
    • Cannister filling and packaging
    • Potent compound handling capabilities
    • DEA-controlled substances licenses
    • Flexible manufacturing and warehouse space
    • Warehousing
    • Vendor qualifications