Injectables

Extreme precision with optimized manufacturing services

Catalent has over 70 years of experience in providing specialized scientific and manufacturing expertise in complex injectable treatments. As the market leader in sterile manufacturing, we offer the latest in innovative fill-finish processes as well as advanced needle safety to improve performance and ensure a patient’s safety. Backed by our global network of manufacturing sites that maintain the highest FDA and EMEA standards, we are committed not only to customizing solutions to your unique needs but also providing the most cost-effective options.

Benefits

We provide a true end-to-end solution that gets your product to market faster.

• The latest in innovative fill-finish processes
• Proprietary technologies that ensure safe, accurate dosing
• Customized product in ready-to-fill or bulk syringes
• Syringe-filling capacity for 100 million units
• Unparalleled in-house design capabilities
• Opportunity for single-dose administration of your products
• Reliable supply with products that meet the highest-quality standards
• Supply site-to-site connectivity supported by global infrastructure

Therapeutic areas

• Low molecular weight heparins
• Monoclonal antibodies
• Oncology products
• Anti-inflammatory
• Ophthalmics
• Vaccines
• Fungicides
• Diluents

Catalent Capabilities

We offer customized solutions for easier administration:

• Syringe-filling
  • Terminal sterilization of filled syringes
  • Syringe top: Luer, Luer Lock, or with needle
  • Automatic needle-shielding system
  • Graduation of the syringes
  • Filling of viscoelastics
  • 100% visual control: fully automatic, semi-automatic, or manual
• Labeling, blistering, and cartoning of syringes
• Prefilled syringes
  • Safety
    • No preservatives equals no allergic reactions
    • Reduces the likelihood of medication-dosing errors
    • Decreases the risk of needle-stick injury (see our Protector Safety Shield System™ below)
  • Convenience
    • Provides an accurate single dose in a convenient, ready-to-use format
    • Cost effective
    • Precise filling eliminates costly waste
  • Reimbursement
    • Supports in-home care of chronic diseases (a growing Medicare trend) rather than more costly outpatient treatment.
    • Catalent’s ASI™` autoinjector, provided through a collaboration with The Medical House: offering enhanced ease of use for health care providers and facilitating patient’s self-administration
  • Product differentiation
    • Offers maximum flexibility and customization via our expertise in a wide variety of container closure systems, combined with our packaging design services
  • Global capabilities
    • Extends your global reach  - with extensive site registrations by FDA, EMEA, and Japanese health authorities.
  • The Catalent advantage
    • Access to our expertise and capabilities across a full range of services, from formulation development to packaging/clinical supply services
• ASI™ Autoinjector and ultra-compact ASI Mini™ Autoinjector
  • Tailored to meet your requirements
  • Clinician and patient preference
  • Simple, but intuitive operation
  • Versatile technology
• Diluents in prefilled syringes
  • Stability studies of WFI (water for injection) and saline solutions in prefilled syringes, now available for our customers
• IV bag filling
  • Filling and packaging of flexible bags
  • (50ml to 3L - aseptic or terminally sterilized)
  •  Aseptic filling of bags
  • Unique capability (niche product  250 ml => 5,000 ml)
  • Terminal/final sterilization
  • PVC bags/PP bags (40ml => 4,000ml)
  • Dual chamber bags
  • Provides ability to provide infusion bags when working with complex solutions

Facilities

All of our sites are subject to annual review so we can remain in compliance with:

• FDA/cGMP
• Canadian HPB
• British MHRA
• European community
• Brazilian authorities

We have two manufacturing facilities in Europe that serve Injectable needs:

• Brussels, Belgium
  • Facility stats
    • Total (2 floors): 9,060m
    • Sterile: 2,600m
    • Packaging: 1,750m
    • Warehouse: 2,450m
    • Lab: 760m
    • Office: 1,500m
  • Compliancy
    • EMEA approved
    • FDA approved
  • Capacity
    • 200 million PFS
    • Pre-treated syringes (SCF, RTF): from 0.5ml to 50ml
  • Development capabilities
    • Aseptic filling
    • Autoinjectors
    • Safety-device capabilities
    • Marking, labeling – 4 lines
    • Final packaging in blister and cartoning – 2 high-speed lines
  • Advantages
    • State-of-the-art facility
    • High filling capacity and speed
    • Flexible options for PFS size
    • High capacity for vaccines storage
  • Compounding
    • 1 solution preparation room per filling line
    • 1 separated solution preparation room for long prep
    • Diluent capabilities, including water for injection system
    • Centralized and permanent environmental monitoring
• Limoges, France
  • Specialties
    • Injectables since 1977
    • Bulk system pre-filled syringes – filling and packaging
    • Aseptic filling or terminal sterilization of intravenous bags
      • Pediatric parenteral nutrition products
      • Organ-keeping solution
      • Generics
  • Capabilities
    • Syringes
    • Bulk system: 0.5ml syringe with needle (bulk = washing, siliconization, sterilization made in-house)
    • SCF syringes to be available
    • Needle shield capabilities available
    • IV bag filling

ASI and Protector Safety Shield System are trademarks of The Medical House