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ADMA Biologics Achieves Milestone With FDA Approval For Enhanced Production Process

$ADMA

ADMA Biologics, Inc. (NASDAQ:ADMA) has recently marked a significant achievement with the US Food and Drug Administration’s approval of its innovative immunoglobulin production process. The approved process, which is the first of its kind in the US, allows ADMA Biologics to increase its production yields by approximately 20% from the same starting plasma volume.

This is a crucial development for the company as it continues to leverage its FDA-licensed plasma fractionation and purification facility in Boca Raton, Florida. Through its subsidiary, ADMA BioCenters, the company also operates as an FDA-approved source plasma collector, which provides a steady supply of blood plasma for product manufacturing.

Adam Grossman, President and CEO of ADMA Biologics, expressed his enthusiasm about the FDA’s approval, stating, “This approval represents a pivotal milestone for ADMA, unlocking the opportunity for meaningful acceleration in our revenue and earnings trajectory beginning in late 2025 and accelerating further into 2026 and beyond.” He also highlighted the company’s commitment to advancing its production capabilities and developing novel pipeline programs, which include SG-001, a pre-clinical, investigative hyperimmune globulin targeting S. Pneumonia.

ADMA Biologics is well-known for its comprehensive approach to biopharmaceutical manufacturing, marketing and development, focusing on specialty biologics for the treatment of immunodeficient patients at risk for infection. The company’s portfolio includes three FDA-approved plasma-derived biologics: ASCENIV™, BIVIGAM® and NABI-HB®, each designed to address critical needs in immune-compromised patient populations.

The company’s innovative approach to production not only strengthens its market position but also underscores its role as a leader in the biopharmaceutical industry. As ADMA continues to expand its production capabilities and advance its R&D efforts, it remains at the forefront of addressing the complex challenges faced by immune-compromised populations.

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