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Akorn Gets First Lyo-Product Approval for Decatur Site

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The FDA has granted supplemental NDA approval for Akorn, Inc.’s IC-Green for Injection, USP. This approval is Akorn’s first lyophilized product approval for manufacture in its Decatur, IL production facility.     The company has invested approximately $23 million in a new liquid and lyophilized injectable manufacturing fill line at its Decatur facility. In December 2007, the company announced successful results of an FDA pre-approval inspection (PAI) for lyophilized products.     Art...

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