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ADMA Receives Department of Health and Human Services U.S. License
RAMSEY, N.J. and BOCA RATON, Fla., April 02, 2019 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA" or the "Company"), a vertically integrated
About this update from Adma Biologics Inc
[{"type":"text","content":"RAMSEY, N.J. and BOCA RATON, Fla., April 02, 2019 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) (\"ADMA\" or the \"Company\"), a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that manufactures, markets and develops plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases, announces that the U.S. Food and Drug Administration (\"FDA\") has issued a Department of Health and Human Services U.S. license No. 2019 to the Company in connection with the approval of ASCENIV™ Immune Globulin Intravenous, Human - slra 10% Liquid.The license covers the Boca Raton, FL manufacturing facility which has demonstrated compliance with FDA requirements as well as authorizes ADMA to manufacture and enter into interstate commerce with ASCENIV™.About ADMA Biologics, Inc. ( ADMA )ADMA Biologics is a vertically integrated commercial biopharmaceutical company that manufactures, markets and develops specialty plasma-based biologics for the treatment of Primary Immune Deficiency Disease (\"PI\") and the prevention and treatment of certain infectious diseases. ADMA's mission is to develop and commercialize plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases. The target patient populations include immune-compromised individuals who suffer from an underlying immune deficiency disease, or who may be immune-compromised for other medical reasons. ADMA has received U.S. Patents 9,107,906, 9,714,283, 9,815,886 and 9,969,793 related to certain aspects of its products. For more information, please visit www.admabiologics.com.About ASCENIV™ (Formerly referred to as RI-002)ASCENIV™, Immune Globulin Intravenous, Human - slra 10% Liquid, is a plasma-derived, polyclonal, intravenous immune globulin (\"IVIG\"). ASCENIV™ is protected by U.S. Patents: 9,107,906, 9,714,283 and 9,815,886. ASCENIV™ is manufactured using our unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and plasma from donors tested using our proprietary microneutralization assay. ASCENIV™ contains naturally occurring polyclonal antibodies. ASCENIV™ is indicated for the treatment of Primary Humoral Immunodeficiency (\"PI\") in adults and adol...