SAFC Pharma, a member of the Sigma-Aldrich Group, plans a $30 million expansion to its Madison, WI facility to increase its capacity to produce commercial scale High Potency Active Pharmaceutical Ingredients (HPAPIs). The investment includes the purchase of 15 acres of land in Verona, WI near its existing HPAPI production site, where the company will build a new 45,000-sq.-ft. manufacturing facility that will house commercial scale reactors capable of producing HPAPI batch sizes of 4,000 liters. Construction is expected to be complete by year-end 2009.
The facility's design will maximize efficiencies and safe handling in high potency development and adhere to Category IV standards. The site will seek Safebridge certification upon completion. The facility will include state-of-the-art development labs, a 150-liter mini-processing plant and two large-scale cGMP manufacturing suites. The building will have quality control labs, a potent compound packaging area and warehouse and office space, as well as space to expand.
"Currently, there is minimal manufacturing capacity to support market demand for large-scale HPAPI production," said Dave Feldker, SAFC Pharma vice president of sales and manufacturing, U.S. "We are committed to providing customers with the best possible HPAPI manufacturing services, and our new investment at Madison will enable us to continue to meet the increasing demand for HPAPI production and put us at the forefront in manufacturing commercial- scale high potency materials."