From complete process development and clinical scale-up services to commercial manufacture, we offer a full range of development and manufacturing solutions to our partners.
Our commercial manufacturing operations are located in Grand Rapids, Michigan, encompassing more than 200,000 square feet of space, including compounding, conversion and packaging equipment with a capacity to manufacture well over 100 million patches annually.
Our GMP facilities are FDA and DEA registered, ISO9001 and ISO13485 certified and are licensed to handle scheduled drugs and compounds requiring hazardous material handling. We are qualified for the manufacture of over-the-counter (OTC), medical device and prescription transdermal, dermal, mucosal and wound care products.
In addition to batch compounding and continuous solvent cast technology necessary for the manufacture of many types of transdermal, dermal and mucosal products, Corium is one of a very few companies to utilize extrusion technology for the manufacture of these products. This extrusion technology enables greater formulation flexibility to achieve optimal drug delivery and results in lower product costs by avoiding solvents and requiring less cycle time and labor due to the single-step, continuous nature of the process.
Corium has manufactured millions of transdermal patches over the years and has expertise in all stages and types of transdermal, dermal and mucosal manufacturing, including:
- Process development and scale-up
- Prototype, pilot, and commercial manufacturing
- Primary, secondary and tertiary packaging
- Liquid compounding using hazardous solvents and Active Pharmaceutical Ingredients (APIs)
- Twin screw extrusion and mixer-extrusion capabilities
- High speed, high accuracy die cutting and customization (including integrated die cutting and pouching); and
- Analytical method development, validation and quality control with physical testing and analytical method capabilities