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Facilities
Our development and production facilities
offer our clients the choice of continued development through all clinical
phases validation, registration, and commercial supply.
With Process R&D
facilities located in Florence, South Carolina, IRIX can evaluate and
conduct small-scale laboratory and safety testing necessary for a
candidate’s continued development towards pilot scale and ultimately
commercial production. The Florence laboratories are comprised of four large
non-cGMP process R&D laboratories and three smaller cGMP laboratories for
early stage, small volume clinical supply. |
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IRIX Pharmaceuticals, Inc., operates pilot plants—all cGMP—in Florence and
Greenville, South Carolina. The pilot facilities contain fourteen fixed
reactors, ranging from 200 liter to 2000 liter, and can operate at
temperatures down to (-) 100 Cş.IRIX Pharmaceuticals, Inc. also provides a unique service in laboratory
development of b-Lactams. Pressures of 1000 psig can be reached at
specific facilities.
The Florence facility was visited by the FDA in June 2006 with no 483s issued
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IRIX also operates a stand-alone commercial cGMP facility in Greenville,
South Carolina, with vessels ranging from 800 liter to 8000 liter. This
commercial facility is designed to aid clients in the production of
registration and validation batches and can meet the "niche" commercial
volumes of many of the newer API’s being developed today. IRIX's commercial high-containment,
high-pressure and Cryogenic/low-temp equipment is located at the Greenville site.
The Greenville facility was visited by the FDA in May 2006 with no 483s issued. |
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With the complement of development
laboratories, multi cGMP pilot plants, and a new commercial cGMP facility,
IRIX Pharmaceuticals, Inc. has truly become one of the leading CRMO’s in the
pharmaceutical industry today.
Facility
Locations |
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