ADMA Biologics Receives FDA Approval for VanRx Aseptic Fill-Finish Machine and Related Operations Inbox

ADMA Biologics, an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, announced that the FDA has granted approval for the Company’s in-house aseptic fill-finish machine, the VanRx SA25 (“VanRx”).

“The FDA approval of the VanRx marks the successful completion of ADMA’s multi-year supply chain enhancement initiative, firmly establishing ADMA as the only American domiciled end-to-end producer of specialty plasma-derived biologic drugs. Today’s announcement is expected to have transformative financial and strategic implications for ADMA as the Company now joins an elite group of U.S.-based drug manufacturers with comprehensive in-house control of its critical manufacturing functions,” said Adam Grossman, President and Chief Executive Officer of ADMA. “The VanRx approval provides ADMA with internal fill-finish operations, capable of sufficiently addressing all forecasted production requirements for our commercial products. With the VanRx operational, we are anticipating meaningfully improved gross margins, enhanced patient supply consistency, accelerated inventory production cycle times, and increased control and visibility of commercial product lot releases, creating more predictable near-term revenue results.

The VanRx fill-finish machine utilizes a state-of-the-art closed isolator design, allowing for the removal of human interventions and providing safe drug products for patients. The VanRx machine has the capability of rapidly switching between different container and closure formats, enabling aseptic filling in a variety of different fill volumes and presentation sizes. The combination of the FDA-approved increased BIVIGAM® manufacturing production scale earlier this year as well as the enhanced vertical integration resulting from this approval of the VanRx machine is expected to allow ADMA to bring its products to market faster, improve gross margins and substantially increase ADMA’s end-to-end control over its critical manufacturing process. ADMA will continue to work with its third-party contract manufacturing organization (CMO) fill-finish partner who will continue to fill a portion of ADMA’s production at their site. The CMO’s site will remain in ADMA’s FDA-approved product Biologics License Applications to provide the Company with alternatives on a go-forward basis to ensure continued supply-chain robustness.

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