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ADMA Biologics Announces FDA Approval of Extended Shelf Life for ASCENIV™ & BIVIGAM® from 24 to 36 Months
Approval of 36-month shelf life encompasses all ASCENIV & BIVIGAM vial sizes, production scales, as well as internal and external fill-finishing Extended
About this update from Adma Biologics Inc
[{"type":"text","content":"Approval of 36-month shelf life encompasses all ASCENIV & BIVIGAM vial sizes, production scales, as well as internal and external fill-finishing Extended shelf life ASCENIV & BIVIGAM now commercially available to U.S. healthcare providers RAMSEY, N.J. and BOCA RATON, Fla., March 25, 2022 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, announced the United States Food and Drug Administration’s (“FDA”) approval to extend the expiration dating from 24 to 36 months for both its ASCENIV and BIVIGAM immune globulin (“IG”) drug product stored at 2-8°C. The expiration date extension applies to all existing ASCENIV and BIVIGAM lots currently in the commercial supply chain as well as to future production of ASCENIV and BIVIGAM in all vial sizes, production scales as well as internal and external fill-finished drug product. “The extension of ASCENIV’s and BIVIGAM’s shelf life to 36 months dating is a meaningful enhancement of each product’s go-to market offering as it should provide for a more efficient net working capital cycle for the Company as well as allow for more versatile utilization and inventory management by providers,” said Adam Grossman, President and Chief Executive Officer of ADMA. “The approval represents an important milestone as it pertains to the culmination of remediation initiatives enacted since ADMA acquired the Boca Raton, FL manufacturing facility in 2017. We believe this FDA approval of shelf-life extension clearly demonstrates ADMA’s IG portfolio and production processes are of a high-quality and meet all requirements for stability in the eyes of regulators.” Mr. Grossman continued, “The milestone approval validates the optimization of ADMA’s manufacturing processes and ongoing regulatory compliance, which has been spearheaded by the Company’s industry-leading regulatory, compliance, quality, production and supply chain teams. In an IG market faced with volatile supply and demand dynamics, we believe this approval will lend confidence to our distribution partners and caregivers in their procurement decision making. The new 36-month dating for ASCENIV and BIVIGAM now puts ADMA’s IG portfolio on a level playing field with competitor product offerings. We look ...