Associates of Cape Cod, Inc. Receives FDA Approval to Manufacture Pyrotell® Single Test Vials (STV) at New Facility

East Foulmouth, 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, recently announced that the U.S. Food and Drug Administration (FDA) has granted approval to manufacture one of the Company's most prominent products at its new Falmouth Technology Park facility. This product, Pyrotell® Single Test Vial (STV) gel-clot reagent is used for release testing of injectable drugs, biologicals and medical devices for bacterial endotoxin contamination.

Previously, this product was 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.

"With the FDA's approval of our Pyrotell® 5mL and Pyrotell(R)-T in March, we are now poised to manufacture our full line of Pyrotell® products at our new facility," said President and Chief Executive Officer of ACC, Dr. A.J. Meuse. "This consolidation of our products into our new facility will help us quickly meet our customer's requests as well as allow ACC to maximize our efficiencies in large scale manufacturing."

SOURCE: Associates Of Cape Cod