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ADMA BioCenters Receives FDA Approval for Third Plasma Collection Center
Oct. 03, 2018 09:07AM PST
Pharmaceutical InvestingADMA Biologics (NASDAQ:ADMA) a vertically integrated commercial biopharmaceutical company that develops, manufactures and markets specialty plasma-based biologics for the treatment of Primary Immune Deficiency Disease and the prevention and treatment of certain infectious diseases, announces that the Company’s wholly-owned subsidiary, ADMA BioCenters, has received U.S. Food and Drug Administration approval for its third plasma collection …
ADMA Biologics (NASDAQ:ADMA) a vertically integrated commercial biopharmaceutical company that develops, manufactures and markets specialty plasma-based biologics for the treatment of Primary Immune Deficiency Disease and the prevention and treatment of certain infectious diseases, announces that the Company’s wholly-owned subsidiary, ADMA BioCenters, has received U.S. Food and Drug Administration approval for its third plasma collection center, located at 166 Ernest W Barrett Parkway, NW, Marietta, Georgia.
As quoted in the press release:
The facility commenced operations and initiated source plasma collection in December 2017, and is now FDA licensed to collect and enter into interstate commerce to sell and use the human source plasma for further manufacturing in the U.S.
Additionally, ADMA BioCenters has received FDA approval for a license supplement to collect whole blood from donors with a rare blood type to produce source plasma that contains high levels of Anti-D antibodies which is the basis for producing Rhoₒ (D) Immune Globulin (Anti-D Ig). Other plasma products manufacturers use this Anti-D high-titer plasma to make a hyperimmune globulin which is used to prevent and treat conditions associated with Rh negative blood type. Market prices for Anti-D plasma can be as much as two times that of normal source plasma.
“FDA approval of our third plasma collection facility is an important milestone that enables us to continue to internally supply a portion of our raw material, as well as collect other hyperimmune source plasma for the manufacturing of ADMA’s products in our Boca Raton, FL facility or for sale to other customers,” stated Adam Grossman, President and CEO of ADMA Biologics. “As a vertically-integrated plasma products manufacturer, operating raw-material source plasma collection facilities allows us to continue to leverage our know-how and potentially expand our ADMA BioCenters business in the future to meet our growing demands. I am pleased that we obtained approval of this facility and our license supplement well ahead of our expected timeline and we are grateful to our dedicated and knowledgeable staff for meeting this important milestone.”