How the FDA helped this drugmaker overcome its manufacturing dilemma

A recent decision by the Food and Drug Administration will allow Keryx Biopharmaceuticals to overcome a large obstacle in the manufacturing of its kidney drug Auryxia, according to the Boston Business Journal.

In August, the Boston-based drugmaker stopped manufacturing Auryxia due to issues with its manufacturer over converting active pharmaceutical ingredients into finished pills.

On Wednesday, the FDA approved the use of a second manufacturer, allowing Keryx to reinitiate manufacturing processes and supply the drug to wholesalers.

"Getting a second drug product manufacturer approved was an important step to ensuring long-term supply of Auryxia is consistently available to patients," said Keryx CEO Greg Madison in a statement.

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