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ADMA Receives FDA Approval for Increased IVIG Production Scale

Increases plant manufacturing capacity from 400,000L to 600,000L.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

ADMA Biologics, an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, has received approval from the FDA for the company’s expanded manufacturing process, enabling fractionation and purification of a 4,400-liter plasma pool for the manufacture of Intravenous Immune Globulin (IVIG).   “The FDA approval of the 4,400-liter IVIG plasma pool production scale process is a transformative milestone for the ADMA organiz...

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