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Amphastar Pharmaceuticals Receives Approval for Amphadase Supplement

Marks the first product from its China facility

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The U.S. Food and Drug Administration (FDA) granted approval of the Amphastar Pharmaceuticals’ new drug application (NDA) supplement for Amphadase (hyaluronidase injection). This marks the first FDA approved starting material from the company’s subsidiary, ANP, located in Nanjing, China, and signifies that this facility has been qualified by the FDA. Amphadase will compete in the hyaluronidase market, which had sales of $23 million for the 12 months ended March 31, 2015, according to IMS Heal...

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