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news.Rhei Pharmaceuticals, Access Pharmaceuticals' MuGard partner in China, has received regulatory and marketing approval for MuGard from the State Food and Drug Administration (SFDA) to treat oral mucositis in cancer patients.
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In 2011, Access and RHEI have signed a $30m supply agreement for MuGard to ensure manufacturing capacity of up to a minimum of $30m of product in the licensed territories.
Access also approved a sub-license agreement between RHEI and Jian An Pharmaceuticals to leverage Jian’s sales, marketing and regulatory infrastructure for the launch of MuGard in China and Taiwan.
The company plans to begin manufacturing of MuGard in the US to meet the demand created by Jian An.
Access Pharmaceuticals president and CEO Jeffrey Davis said that receiving final marketing approval from the SFDA of China is a transformative milestone for their global MuGard program.