Fleming Pharmaceuticals, maker of ThyroShield®– the only FDA approved liquid potassium iodide product indicated for thyroid protection in radiation emergencies – announced today that it has implemented the changes necessary to ramp up production to meet increased domestic and international demand.
ThyroShield is an over-the-counter iodide solution which, when taken orally, saturates the thyroid gland so radioactive iodine cannot be absorbed. ThyroShield is especially effective for babies and children, who are most at risk during radiation exposure.
"The March 11 incident at Japan's Fukushima Daiichi power plant has increased awareness of the need for preparedness in the event of a major nuclear emergency," stated Phill Dritsas, president of Fleming Pharmaceuticals. "Based on the number of inquiries we have received in the past month from governments, hospitals and others around the world, it is clear to us that we need to do everything within our power here at Fleming to help meet the need for global and domestic relief. We've responded by taking steps to ensure that we can significantly increase production of ThyroShield."
Working closely with the FDA, Fleming Pharmaceuticals has qualified a new potassium iodide (KI) supplier to ensure a steady supply of quality raw materials to manufacture ThyroShield. The company has also established new agreements with vendors to shorten lead times needed to complete orders for ThyroShield package components such as bottles, caps and droppers. Finally, Fleming Pharmaceuticals has completed a thorough audit to identify production line logistics that can be immediately implemented to fulfill any significant new orders for ThyroShield.
"ThyroShield was developed under the Orphan Drug Act – a federal law designed to encourage the development of pharmaceuticals that have limited commercial potential," Dritsas said. "It has always been made-to-order, rather than produced in mass quantities like other, more common over-the-counter medications. With the production changes we've implemented over the past six weeks, we are confident that we can now fulfill increase in demand for the product."
SOURCE Fleming Pharmaceuticals