Lauren Auten

IRIX Pharmaceuticals

IRIX Pharmaceuticals, Inc. is a privately held company engaged in the generation of process technology for new and existing drugs. IRIX offers the full capability of supplying API's and complex pharma intermediates from pre-clinical stages, through all phases of clinical trials, registration/validation batches, launch and ongoing commercial quantities. Formed to provide the Pharmaceutical Industry with a low-cost alternative for bringing new drugs to market rapidly, IRIX operates three sites for Process R&D and Clinical through Commercial cGMP production of API's. Process R&D and early stage clinical supply for API's is based in Florence, South Carolina. Late-stage clinical supply and commercial production is located in Greenville, South Carolina. IRIX ensures compliance with all regulatory and quality requirements. Both the Greenville and Florence site were visited by the FDA in 2008 and 2009, respectively, with no 483s issued for either site. IRIX supports new drug development in all functions necessary to bring a pharmaceutical candidate from discovery to market. IRIX provides seamless technology transfers both to/from Clients and internally for API syntheses. The demonstrated expertise of the IRIX staff and the company's emphasis on quality, economics, and timely delivery make it a choice CRMO (Contract Resources and Manufacturing Organization) for innovative pharmaceutical clients desiring to bring new drugs to the market rapidly. Operating as an extension of the internal resources, IRIX offers sharp process solutions for an accelerated time to market at a very competitive cost.