ACC Receives Approval To Manufacture Pyrotell® and Pyrotell®-T at New Facility

East Falmouth, MA - Associates of Cape Cod, Inc. (ACC), a leading manufacturer of endotoxin and beta-glucan detection products and a major supplier to the pharmaceutical and medical device industries, today announced that the U.S. Food and Drug Administration (FDA) has granted approval to manufacture two of the Company's most prominent products at its new Falmouth Technology Park facility. These two products, Pyrotell® 5 mL gel-clot reagent and Pyrotell-T® turbidimetric reagent, are used for release testing of injectable drugs, biologicals and medical devices for bacterial endotoxin contamination.

This announcement follows the successful completion of a rigorous audit in which FDA Inspectors conducted a comprehensive evaluation of the facility and the Pre-Approval Submission (PAS). These products had previously been manufactured at ACC's Main Street facility in Falmouth, Massachusetts for twenty years. The Company's new state-of-the-art facility is designed specifically for the manufacture of Horseshoe Crab blood extract, or Limulus Amebocyte Lysate (LAL), reagents and associated products. Submission for the approval of manufacturing of ACC's other licensed products at the new facility will be proposed to the FDA in the near term.

"We are very pleased with the outcome of the FDA audit," said President and Chief Executive Officer of ACC, Dr. A.J. Meuse. "The FDA's approval further illustrates our commitment to produce the highest quality product possible and to deliver products and services which completely satisfy our customers' expectations."

SOURCE: Associates Of Cape Cod