Business
ADMA Biologics Receives FDA Approval for VanRx Aseptic Fill-Finish Machine and Related Operations
Expected to Provide Improved Gross Margins, Enhanced Patient Supply Consistency, Accelerated Inventory Production Cycle Time and Increased Control and
About this update from Adma Biologics Inc
[{"type":"text","content":"Expected to Provide Improved Gross Margins, Enhanced Patient Supply Consistency, Accelerated Inventory Production Cycle Time and Increased Control and Visibility of Commercial Product Lot Releases Additional Opportunity for Contract Manufacturing Filling Services and Capabilities to Third Parties RAMSEY, N.J. and BOCA RATON, Fla., Sept. 08, 2021 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, announced that the U.S. Food and Drug Administration (“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 approval of the VanRx will also provide ADMA with the opportunity to onboard new fill-finish contract manufacturing opportunities with third parties. This additional revenue stream can provide the Company with the ability to potentially exceed previous financial targets, which we will update as progress unfolds. With extensive vertical integration successfully established and the Company’s more meaningful capital investment initiatives having now concluded, ADMA is entering the next phase of its profit-focused growth strategy. We look forward to sustaining quarter-over-quarter revenue growth f...