Positron Corp., a molecular imaging and solutions company specializing in Nuclear Cardiology and Cardiac PET, announced on August 10 the opening of a cGMP ready (current good manufacturing practices) facility in Indiana. The company will manufacture both radioactive and non-radioactive pharmaceutical products and devices at the plant.
"While our plan is to focus on small batch, radioactive PET products, the facility will also be utilized to support current and future Positron equipment, as well as, expand into new markets. We are presently in discussions with several entities that can utilize our contract manufacturing services," said John Zehner, COO of Positron.
The 10,000 square foot facility, with room for expansion, contains clean room space and laboratory equipment to support the production of pharmaceutical and support products for both industrial and medical use. These products will meet or exceed Food and Drug Administration (FDA) current good manufacturing practices (cGMPs), the company said. This will allow for the production of products under 510ks, ANDAs, NDAs and INDs, as well as, certified compounding products for pharmacy use.