Bio-Nucleonics

Bio-Nucleonics Inc. is a privately held, life sciences company located in the United States. The company develops, manufactures, and markets radiopharmaceuticals, medical devices, and imaging agents to detect and treat cardiovascular, oncological, and neurological diseases. Approved by the U.S Food and Drug Administration (FDA), the U.S. Nuclear Regulatory Commission, and the Florida Board of Pharmacy,[1] it is the only U.S. company focused on the development and production of generic radiopharmaceuticals.[2]

Regulations

The company is regulated by the U.S. Food and Drug Administration (FDA), the U.S. Nuclear Regulatory Commission, the Florida Bureau of Radiation Control,[3] and the Florida Board of Pharmacy. Its products undergo rigorous validation and testing in accordance with current Good Manufacturing Practice, Good Laboratory Practice, and Quality System Requirements.[4]

Products and services

Bio-Nucleonics' lead product is Generic Strontium Sr-89 Injection USP (Strontium-89),[5] which is the generic version of Metastron.[6] Generic Strontium-89 is an option to consider for cancer bone pain therapy. It imitates the behavior of calcium and is preferentially absorbed by bone, concentrating at sites of painful metastatic bone disease. Generic Strontium-89 injection is a pure beta emitter, and selectively irradiates sites of primary and metastatic bone involvement with minimal irradiation of soft tissues distant from bone lesions.[7]

Honors and awards

Bio-Nucleonics Inc., received the 2009 "Best of Doral Award" in Radioactive Diagnostic Substances,[8] as well as Miami's Beacon Council "Key to the County", in recognition of its importance to the Miami-Dade County economy.[9]

References

  1. ↑ "Board Overview - Florida Board of Pharmacy - Board Overview". Doh.state.fl.us. Retrieved 2011-06-13.
  2. ↑ "Bio-Nucleonics, Inc.: Private Company Information - BusinessWeek". Investing.businessweek.com. 2011-06-07. Retrieved 2011-06-13.
  3. ↑ Department of Health, Division of Environmental Health, Environmental Health. "Radiation Control". Doh.state.fl.us. Retrieved 2011-06-13.
  4. ↑ "Quality System (QS) Regulation/Medical Device Good Manufacturing Practices". Fda.gov. Retrieved 2011-06-13.
  5. ↑ "Bio-Nucleonics Continues Production of Cancer Drug". MarketWatch. 2011-06-07. Retrieved 2011-06-13.
  6. ↑ "First-Time Generics - January 2003". Fda.gov. 2009-04-30. Retrieved 2011-06-13.
  7. ↑ "Radiopharmaceuticals Metastron® (Strontium-89) and Samarium-153 (Quadramet) for Metastatic Bone Pain". Aetna.com. Retrieved 2011-06-13.
  8. ↑ "Bio-Nucleonics, Inc Receives 2009 Best of Doral Award « Inspired By Innovative Ingenuity". Biobulletinblog.wordpress.com. Retrieved 2011-06-13.
  9. ↑ "Project Recognition Key Ceremony 2008 « Inspired By Innovative Ingenuity". Biobulletinblog.wordpress.com. Retrieved 2011-06-13.

External links

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