ADMA Biologics [NASDAQ: ADMA] Gets FDA Approval for Increased IVIG Production Scale

ADMA Biologics, Inc. [NASDAQ: ADMA] disclosed Wednesday that it has got the FDA authorization for the expanded manufacturing process of the firm. It will allow the firm the purification of a 4,400-liter plasma pool for the making of Intravenous Immune Globulin IVIG. This authorization for a 4,400-liter IVIG plasma pool is the greatest achievement for the firm.

This authorization will further help the firm to produce more IVIG for the U.S. market and for sufferers experiencing immune deficiencies. The firm revealed that the expanded plasma pool will enable the firm to attain revenues in excess of $300 million. This authorization fixes the pathway to meaningful gross margin development commencing likely in the second half of 2021 and stimulating throughout 2022. 

Shares of ADMA Biologics skyrocketed 26.84% at $2.41 at the time of writing on Wednesday. The strong performance of the firm demonstrated the positive sentiments of investors after the firm has got the FDA approval. Additionally, the firm is also reemphasizing its anticipations for quarter-over-quarter revenue increase throughout 2021 and beyond.

Furthermore, the 4,400-liter IVIG plasma pool scale for BIVIGAM will enable ADMA to grow its manufacturing plant’s total processing capacity from 400,000 liters to an expected peak throughput of up to 600,000 liters. After the approval of the FDA, the firm has the ability to speed up the BIVIGAM in expanded capacity in the same way as the earlier production capacity.