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ADMA Biologics Expands Global Regulatory Approval Presence and Announces FDA Approval to Commence Hepatitis B Plasma Collections

Nachrichtenquelle: globenewswire
03.03.2021, 14:00  |  101   |   |   

RAMSEY, N.J. and BOCA RATON, Fla. and KENNESAW, Ga., March 03, 2021 (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, today announced that its plasma collection center located in Kennesaw, Georgia received approval from the Korean Ministry of Food and Drug Safety (MFDS) for the sale of source plasma into South Korea. In conjunction with the South Korean approval, ADMA additionally announced the Kennesaw plasma collection center received FDA approval to implement a Hepatitis B immunization program, enabling ADMA to collect source plasma from donors immunized with an FDA-licensed Hepatitis B vaccine.

“These approvals demonstrate ADMA’s strict adherence to the regulatory requirements of the global plasma community and build upon the significant regulatory milestones already achieved by our Company in 2021,” said Adam Grossman, President and Chief Executive Officer of ADMA Biologics. “The approvals announced today further enhance our existing global presence as a source plasma provider, which includes the United States and now South Korea. Our BioCenters expansion strategy remains comfortably on track, and these approvals represent another important step towards our objective of further securing our raw material supply chain and enhancing our end-to-end control of manufacturing operations.”

About ADMA BioCenters

ADMA BioCenters is an FDA licensed facility specializing in the collection of human plasma used to make special medications for the treatment and prevention of diseases. Managed by a team of experts who have decades of experience in the specialized field of plasma collection, ADMA BioCenters provides a safe, professional and pleasant donation environment. ADMA BioCenters strictly follows FDA regulations and guidance and enforces cGMP (current good manufacturing practices) in all of its facilities. For more information about ADMA BioCenters, please visit www.admabiocenters.com.

About ADMA Biologics, Inc. (ADMA)

ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. ADMA currently manufactures and markets three United States Food and Drug Administration (FDA) approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: BIVIGAM (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA BioCenters subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of its blood plasma for the manufacture of its products. ADMA’s mission is to manufacture, market and develop specialty plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations who suffer from an underlying immune deficiency, 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, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

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ADMA Biologics Expands Global Regulatory Approval Presence and Announces FDA Approval to Commence Hepatitis B Plasma Collections RAMSEY, N.J. and BOCA RATON, Fla. and KENNESAW, Ga., March 03, 2021 (GLOBE NEWSWIRE) - ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty …

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