Associates of Cape Cod, Inc. Receives FDA Approval to Manufacture at New Facility
Associates of Cape Cod, Inc. (ACC), the 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(R) 5 mL gel-clot reagent and Pyrotell-T(R) turbidimetric reagent, are used for release testing of injectable drugs, biologicals and medical devices for bacterial endotoxin contamination.
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 shortly.
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