Positron Corporation, a molecular imaging and solutions company specializing in nuclear cardiology and a provider of Cardiac PET, has opened a cGMP ready (current good manufacturing practices) facility in Indiana for the manufacturing of both radioactive and non-radioactive pharmaceutical products and medical devices.
Positron said that the approximate 10,000 square foot facility, with room for expansion, contains ample clean room space and laboratory equipment to support the production of device support products for both industrial and medical use.
The products are expected to meet or exceed FDA current good manufacturing practices (cGMP’s), which allows the production of products under 510k’s, ANDA’s, NDA’s and IND’s, as well as, certified compounding products for pharmacy use.
John Zehner, COO of Positron, said: “The opening of this facility marks a significant milestone in Positron’s expansion into the consumables market that began with the acquisition of Dose Shield in 2008.
“Radioactive and non-radioactive pharmaceutical products are a key component of our company’s growth strategy, the opening of such a facility affords us significant advantages in every aspect of our business, which enables us to remain competitive in the future.
“The opening of the manufacturing facility was critical to our plan, as we are equipped with the staff, equipment and space necessary to manufacture a variety of radioactive and non-radioactive pharmaceutical products. While the company’s plan is to focus on small batch, radioactive PET products, the facility will also be utilised to support current and future Positron equipment, as well as, expand into new markets.”
Positron product portfolio include the Attrius, a PET imaging device, Pulse, a SPECT imaging device, Nuclear Pharm-Assist, an automated radiopharmaceutical distribution device and Tech-Assist, a radiopharmaceutical injection shield.