About Celsus Laboratories Inc
Celsus is FDA-registered to manufacture heparin active pharmaceutical ingredients (API’s) in an establishment that has been approved by the USDA to handle restricted animal by-products.
Bulk compendial products and API’s are manufactured in compliance with current good manufacturing practices (cGMP), enforced by periodic FDA-inspections, in a dedicated manufacturing facility in Cincinnati in continuous operation since 1988.
Celsus uses compendial and other validated test procedures to certify the strength, quality and purity of its heparin derivatives. All laboratory tests are performed by Celsus in-house.
Quality Assurance personnel, who are authorized and directed to independently audit manufacture and controls, enforce conformity with cGMP.