IRISYS’ expertise includes specialty commercial manufacturing of single source products and registration batches for Abbreviated New Drug Applications (ANDAs), formulations for rare diseases and orphan drugs. We have a successful track record with a wide range of therapeutic agents having varied physicochemical properties.

The FDA Orphan Drug Designation program provides orphan status to drugs and biologics intended for the treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of development and marketing. Given the limited financial opportunity it is especially important that orphan drug development, and rare disease drug manufacturing, be conducted as efficiently as possible.