Precise dosage perfectly administered
With more than 70 years of sterile manufacturing experience with injectables and a global infrastructure of cGMP and FDA-compliant facilities, we have the expertise, processes, and resources to meet all of your syringe-filling needs. Backed by our team of over 1,000 highly trained scientists, we offer the latest in innovative fill-finish processes, and specialty devices such as auto-injectors and safety shields. Our syringe-filling capacity is over 100 million units.
We do not currently offer development and formulation for prefilled syringes.
Catalent Benefits
- Develop and manufacture specialized delivery technologies that ensure patient’s safety and accurate dosing
- Provide cost-effective, customized manufacturing options for your complex treatments
- Reliably supply products that meet the highest quality standards
- Provide additional services to help you get to market faster and compete more successfully, including:
- Development (stability tests)
- Contract work (quality control – logistics)
- Process development
Catalent Capabilities
- Extensive range of syringe solutions
- 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
- Solution prepared by Catalent or supplied by the customer
- Choice between ready-to-fill or bulk syringes
- Ongoing stability studies of WFI (water for injection) and saline solutions in prefilled syringes
- Expanded ASI™ autoinjector
- Now offered through our collaboration with Bespak, the patented ASI™ autoinjector is a convenient, single-use device that makes assisted injection easier - ideal for self-administration of medications by patients and family members or other non-clinicians
Facilities
- Brussels, Belgium
- 2 Floors: 9,060m
- Sterile: 2,600m
- Warehouse: 2,450m
- Lab: 760m
- Office: 1,500m
- EMEA, FDA, ANVISA approved
- Canadian, Japanese, Australian approved
- Limoges, France
- Total: 12000 sq. meters
- Mfg: 3000 sq. meters
- Packaging: 1200 sq. meters
- Warehouse: 6000 sq. meters
- Lab: 700 sq. meters
- Office: 800 sq. meters
- EMEA, ANIVISA, pending FDA approval
All of our sites are subject to annual review so we can remain in compliance with:
- FDA/cGMP
- Canadian HPB
- British MHRA
- European community (EMA)
- Brazilian authorities
ASI and Protector Safety Shield System are trademarks of The Medical House.