Jubilant Organosys Ltd, headquartered in India, announced today 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 Hari 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 we will be expanding the access to generic Sestamibi for a larger patient population in Canada.
DRAXIMAGE® Sestamibi is a generic of Cardiolite®1.
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About Cardiac Imaging with Tc-99m Sestamibi
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. The radioisotope Technetium-99m is attached to the sestamibi molecule forming Tc-99m Sestamibi. When injected into the bloodstream this radiopharmaceutical agent is distributed throughout the heart muscle in proportion to the blood flow received by various portions of the heart. Heart images are then obtained using a gamma camera that can detect the Technetium-99m. Two sets of images are typically taken, one while the patient is at rest and a second set while the patient is under stress, often by exercising on a treadmill or stationary bicycle. The resulting two sets of images are compared with each other to diagnose the presence of coronary heart disease by detecting areas of the heart that may not be receiving normal blood flow. This imaging technique is known as cardiac stress testing or myocardial perfusion imaging (MPI).
About Jubilant
Jubilant Organosys Ltd. 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. The company has a presence across the pharmaceutical value chain for products and services such as proprietary products ,exclusive synthesis, active pharmaceutical ingredients, contract manufacturing of sterile injectables (liquids and lyophilized) products, non-steriles (ointments, creams and liquid) and radiopharmaceuticals, drug discovery services, medicinal chemistry services, clinical research services ,generic dosage forms and Healthcare. Jubilant Organosys has geographically diversified manufacturing facilities at ten locations worldwide. Together, these help Jubilant cater to 150 customers across more than 50 countries around the world.
For more information: visit www.jubl.com
About DRAXIS
DRAXIS Specialty Pharmaceuticals Inc., provides products in three categories: sterile products, non-sterile products and radiopharmaceuticals. Sterile products include liquid and freeze-dried (lyophilized) injectables plus sterile ointments and creams. Non-sterile products are produced as solid oral and semi-solid dosage forms. Radiopharmaceuticals are used for both therapeutic and diagnostic molecular imaging applications. Pharmaceutical contract manufacturing services are provided through DRAXIS Pharma General Partnership and radiopharmaceuticals are developed, produced, and sold through the DRAXIMAGE division. DRAXIS employs approximately 500 staff in its Kirkland (Québec) facility.
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