Clinical and Commercial Manufacturing
Pharmaceutical pipelines today require more flexibility in manufacturing than ever before. There is an increasing demand in accelerated development programs (i.e., orphan drugs, fast track, breakthrough therapy, accelerated approvals, and priority review) and oncology drugs that require smaller batch sizes, expedited development and manufacturing timelines, and the ability to efficiently adjust production volumes to meet market demands. Therefore, flexibility and adaptability are key to getting your drug to market quickly.
For over 80 years, Catalent has provided flexible manufacturing solutions for pharmaceutical, biologic, and consumer health customers around the world. With our manufacturing expertise, breadth of scalable development and delivery technologies, and our exceptional quality standards, we can support your program requirements with reliable supply to global markets.
Catalent’s FDA, EMA and other domestic and internationally-approved facilities, we can provide flexible manufacturing at the right scale for your project’s clinical and commercial manufacturing needs. Our proven expertise in technical transfers, product launches, dedicated suites, special handling, and manufacturing technologies, Catalent can strategically support a wide range of small- to- large-scale manufacturing services.
- Over 70 billion doses annually, over 30 worldwide locations, and 20 manufacturing facilities
- Manufacturing expertise for oral, biologic, and inhaled dosage forms
- Technical Transfers
- Scale- up and Product Launches
- Dedicated Suites- Catalent forms strategic partnerships with our customers to adapt to unique program requirements. We have dedicated suites within our network of manufacturing sites to accommodate programs with specific air handling, humidity control and/or containment requirements
- Special Handling-Catalent’s growing expertise in supporting potent compounds and controlled substances from development to commercial supply
- Manufacturing Technologies- Catalent has a wide range of manufacturing technologies to provide bioavailability enhancement, increase efficiency and enhance reliability
- Integrated, state-of-the-art facilities in the U.S., Europe, Latin America, and Asia Pacific
- Fast, efficient, reliable global supply through our NEW OptiForm® Total Supply
- Expertise in global product launch
- Scalable manufacturing and commercial packaging solutions
- Manufacturing options for product differentiation, product line extensions, and lifecycle management