Jubilant Organosys Ltd, headquartered in India, announced that its subsidiary in Canada, Draxis has received approval for the generic Sestamibi from Health Canada.
Draximage Sestamibi is a generic Kit for the Preparation of Technetium (Tc 99m) Sestamibi Injection, a diagnostic cardiac imaging agent used for the diagnosis and localization of myocardial infarction; and for the diagnosis and localization of ischemic heart disease and coronary artery disease.
The approval from Health Canada indicates that the agency has concluded Draximage Sestamibi, the generic product, to be safe and effective for use as recommended in the submitted labelling.
Commenting on the approval, Jubilant Organosys chairman and co-chairman, Shyam S Bhartia and Han S Bhartia said, "The approval of Draximage Sestamibi reflects the product quality and capability of Draxis in handling specialized products. This further strengthens our portfolio of radiopharmaceuticals in this market."
The product will be manufactured at the Sterile injectible facility of Draxis at Montreal and will be commercialized later this year post patent expiry. Through the introduction of this product, the company will be expanding the access to generic Sestamibi for a larger patient population in Canada.
The Sestamibi Kit is used in nuclear medicine imaging to show how well the heart muscle (myocardium) is supplied with blood (perfused) both at rest and during strenuous activity.
Jubilant Organosys is an integrated pharmaceutical industry player, one of the largest custom research and manufacturing services (CRAMS) and drug discovery and development services companies out of India.
Draxis Specialty Pharmaceuticals Inc, provides products in three categories; sterile products, non-sterile products and radiopharmaceuticals. Sterile products include liquid arid freeze-dried (lyophilized) injectables plus sterile ointments and creams.