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Expertise from formulation to commercial-scale manufacturing
Catalent Benefits
In-depth expertise and significant investment in talent and technologies across the entire inhalation field
Comprehensive services that can help expedite your product from concept to market
Dosage form selection and technology assessment
Formulation development and analytical testing
Supplying toxicological and clinical trial materials
Commercial-scale manufacturing
Packaging services
Track record of regulatory success around the globe
Catalent Services
Dosage form development
Formulation selection and optimization
Technical requirements
Characterization of aerosols
Device performance
Pump and container selection
cGMP compliance
Product testing
Manufacturing validation support (process and cleaning validation)
In-vitro bioequivalence testing
Release and finished product testing
Article sizing and spray analysis
Drug and delivery assays
Stability studies (ICH and custom conditions)
Structural elucidation of drug-related impurities and degradation products
Extractables and leachables studies – world-renowned scientific staff
Clinical and commercial manufacturing
Complete clinical trials materials preparation in support of Phase I - IV studies for all pulmonary and nasal dosage forms and seamless technology transfer to our commercial manufacturing facilities:
MDI, DPI, nasal sprays, and nebulizer production capabilities
Fully automated MDI production lines
Class 10,000 space
Potent compound handling capabilities
DEA-controlled substances licenses
Flexible manufacturing and warehouse space
Customized facilities built to suit
Both sterile and preserved production capabilities
