1/6/03 - Celsus Laboratories, Inc. (Cincinnati OH) GMP-manufactures in an FDA-inspected facility Heparin Sodium and derivatives thereof from porcine raw material collected entirely in countries without a history of mad cow disease or bovine transmissible spongiform encephalopathy (TSE). Only porcine raw material that tests negative for prion antigens is processed by Celsus using procedures validated for the removal of TSE and viral infectious agents in compliance with EU regulatory guidelines prEN 12442-3 and Ordinance No. 210 of the Ministry of Health, Labor and Welfare (MHLW) of Japan. Heparin Calcium and Heparin Sodium are offered in bulk for further manufacture into Anticoagulant Heparin Solutions, Heparin Lock Flush Solutions, Heparin Calcium Injection, Heparin Sodium Injection and bulk Low Molecular Weight Heparin (LMWH) in Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, Ecuador, Egypt, England, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Iran, Indonesia, Ireland, Israel, Italy, Japan, Korea, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Peru, Philippines, Poland, Portugal, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, the United Kingdom, the United States, Uruguay, or Venezuela. For use in diagnostics and medical devices, Celsus offers for direct sale various water-insoluble and water-soluble heparin salts such as Ammonium Heparin, Benzalkonium Heparin, Lithium Heparin and Zinc Heparin as well as low molecular weight heparin fragments containing free amine or aldehyde moieties for covalent bonding. For additional information, contact Alan D. Cardin, Ph.D. at 800-heparin.
|
||||||
