PARTICLE SIZE AND PRODUCT BREADTH
As one of the world’s largest API suppliers—and only Western supplier of acetaminophen—Mallinckrodt Pharmaceuticals offers customers a broad array of products and specifications. We provide assistance in your product development with custom solutions, formulations and product performance so you can deliver better value to your customers. The breadth of our controlled substance API offerings and particle size of our acetaminophen products positions us as a true partner in your success.
- We collaborate with you every step of the way to manufacture the exact API ingredients and combinations for your precise needs. Our research and development (R&D) staff works directly with you to produce stable APIs that meet the physical property requirements of your specific application—e.g., polymorphism, particular size distribution and bulk density—that lead to improved flow, mixing and compression characteristics.
- We offer the right mix of API and excipient products to support various delivery systems, including oral dosage, immediate- and extended-release, liquid suspensions, adhesive patches, pharmaceutical coatings and taste masking.
- Our experienced technical staff can also assist you in determining the right product and/or particle size for improved handling, blending, dry compaction, granulation, spray drying, tableting and coating.
- Flexible production facilites allow us to manufacture orders from 50 grams up to thousands of kilos. We work directly with customers to develop small lots for clinical trials, and have the capacity to produce large lots when you bring your new product to market.
- As you develop new products, our regulatory and R&D teams work with you to help ensure you have the right regulatory paperwork and specifications to receive approval from regulatory bodies like the United States (US) Food and Drug Administration, the European Medicines Agency and others around the world.
- Mallinckrodt continues its multi-decade partnership with the US Drug Enforcement Administration (DEA) striving/working to match the industry demand for controlled substances with the appropriate annual production of controlled substance APIs. We have a long history and solid reputation with the DEA as an importer, exporter, manufacturer and researcher of controlled substances. This allows us to help customers navigate DEA systems and provide support with quota requests.
Your customers have diverse needs, and Mallinckrodt has the diverse product portfolio to help you meet them. With more than 125 years of experience in API manufacturing, we have both the products and the depth and breadth of experience to help you deliver superior products to your customers. We look forward to servicing your business as your supplier of choice.