Mallinckrodt Pharmaceuticals Outsourcing

Products and Services

As a business unit of Mallinckrodt Pharmaceuticals, we can use the synergy within our Pharmaceuticals Group to take your projects from API sourcing to a successful launch of your commercial product.  Our facilities are audited by a wide range of regulatory bodies, including: Food and Drug Administration (USA), Drug Enforcement Agency (USA), Therapeutic Products Directorate (CANADA), Medicines and Healthcare Products Regulatory Agency (UK).

Our major contract manufacturing services include:

        •  Bulk API
        •  Process Development
        •  Clinical Trials Materials Manufacturing
        •  Analytical Development and Validation
        •  QA/QC Stability Testing Programs
        •  Regulatory Consultation/Submission (IND, NDA, ANDA)
        •  Process Scale-Up and Validation
        •  Commercial Manufacturing and Packaging
        •  Unit Dose Blister Packaging and Barcoding
        •  Product Improvements and Extension
        •  Phase IV