Positron Announces Opening of cGMP Manufacturing Facility
Facility to Focus on Production of Positron Emission Tomography Pharmaceuticals
INDIANAPOLIS, Aug 10, 2010 (BUSINESS WIRE) -- Positron Corporation /quotes/comstock/11k!posc (POSC 0.08, 0.00, 0.00%) , a molecular imaging and solutions company specializing in Nuclear Cardiology and a leader in Cardiac PET, announced today the opening of a cGMP ready (current good manufacturing practices) facility in Indiana for the manufacturing of both radioactive and non-radioactive pharmaceutical products and devices.
"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," stated John Zehner, COO of Positron. "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 this manufacturing facility was critical to our plan, as we are now 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 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," concluded Mr. Zehner.
The Company noted the approximate 10,000 square foot facility, with room for expansion, contains ample 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 (cGMP's). This will allow for the production of products under 510k's, ANDA's, NDA's and IND's, as well as, certified compounding products for pharmacy use.
About Positron: Positron is a molecular imaging company focused on Nuclear Cardiology. Positron utilizes its proprietary product line to provide unique solutions to the Nuclear Medicine community ranging from imaging to radiopharmaceutical distribution. Positron products include: the Attrius(TM), a PET imaging device; the Pulse(R), a SPECT imaging device; the Nuclear Pharm-Assist(R), an automated radiopharmaceutical distribution device; and the Tech-Assist(TM), a radiopharmaceutical injection shield. More information about Positron is available at www.positron.com.