Positron’s 10,000 square foot facility contains ample clean room space and laboratory equipment to support the development and production of pharmaceutical and related products for both industrial and medical use. These products are developed and manufactured to meet or exceed Food and Drug Administration (FDA) current good manufacturing practices (cGMP’s). The facility includes an 800 sq. ft. class 7 clean room, RO water, HPLC, Gamma/Beta HPLC, TLC, controlled media storage, laminar flow hoods, radiation detection and monitoring equipment, air quality monitoring, and hot cell. This will allow for the production of products requiring 510k’s, aNDA’s, NDA’s and IND’s, as well as, certified compounding products for pharmacy use.
Positron’s Crown Point manufacturing facility is fully staffed and optimized for both proprietary and third party contract manufactured products. This facility has the capacity to manufacture small to medium batches of radioactive products. Indium Oxine is currently in pre-production, with several additional radioactive products under development.
For more information about Positron's radiopharmaceutical offerings click here.
