Drug Product Manufacturing
Clinical and Commercial Scale
Quality systems with strong audit history
BioDuro-Sundia has been a center of excellence for Clinical Trial Material (CTM) Phase I/II/III and Commercial manufacturing of oral solid dosages for nearly three (3) decades through legacy manufacturing sites. Our manufacturing technologies include: immediate release (IR), modified release (Delayed Release, Sustained Release and Customer Release) and enabling technologies (Solvent/Aqueous Spray Drying and Hot-Melt Extrusion) for granules, pellets, multi-particulates, powders, sprinkles in the form of tablets, mini-tablets, capsules, and sachets.
Irvine Commercial Capabilities
Our Irvine California Campus offers a total of 100,000 sq. ft. for Phase I, Phase II, Phase III and of Commercial oral solid manufacturing. We provide contract services for the development, manufacture, and analysis of pharmaceutical products. Activities include analytical development and validation, formulation development, manufacture, release and stability testing, packaging, labeling, and storage of clinical supplies and commercial products. The site capabilities include aqueous and organic solvent processes for fluid bed and coating capabilities, amorphous solid dispersion, along with multiple high speed tableting and encapsulation machines with a supply capacity of > 3 billion dosses annually. Our Irvine Facility has also partnered with FDA to showcase and provide training for FDA Consumer Safety Officers and FDA Medica Product Analysts pharmaceutical new and novel technology.