Global Distribution

Celsus manufactures more than 12 heparin derivatives. The regulations that control the manufacture and sale of these products depend on the intended use of the products at the time of sale. For purposes of defining intended use, the objective circumstances between Celsus and its customers control (21 CFR 201.128). When the intended use is a drug substance it is subject to the adulteration provisions of 21 USC §351 (a) and (b). Under (a), a drug is adulterated if it fails to conform to cGMP. Under (b), if a drug with a compendial name fails to have the strength, quality and purity specified in the monograph it is adulterated. Where the intended use is for a component of a device, Celsus is the manufacturer of a component for purposes of 21 CFR §820.1 but under 21 CFR §820.50 its customer has the responsibility to evaluate and control the condition of the component it receives.

Celsus dispatches its products to destinations throughout the world for use in the global distribution prophylaxis and treatment of thrombo-embolic disorders, cardiac surgery, hemodialysis and other extracorporeal procedures, catheter lockflush, blood collection and analysis, blood-interacting medical devices, and affinity chromatography. In support of its global strategy, Celsus maintains drug master file credentials with regulatory authorities in Australia, Canada, the European Union, Japan, and the United States.