Search This Blog

Monday, March 7, 2022

ADMA Receives FDA Approval for Fifth Plasma Collection Center, in GA

 FDA approval supports corporate goal of plasma supply self-sufficiency and ongoing revenue growth

Company positioned to meet or exceed target of 10 or more FDA-approved plasma collection centers by year-end 2023

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 it has received U.S. Food and Drug Administration (“FDA”) approval for its fifth ADMA BioCenters plasma collection facility located in Conyers, Georgia. This plasma collection facility commenced operations and initiated source plasma collection in the third quarter of 2021. With the approval announced today, this facility is now FDA-approved to collect and introduce into interstate commerce, human source plasma for further manufacturing in the U.S.

“The successful expansion of ADMA’s plasma collection network supports the Company’s goal of plasma supply self-sufficiency and ongoing revenue growth objectives, and importantly, further solidifies the pathway towards profitability. The approval is a testament to the BioCenters team’s tireless commitment, and we thank the FDA for its efforts and expeditious review of the Conyers, GA Biologics License Application (“BLA”), which came well in advance of the agency’s targeted approval date,” said Adam Grossman, President and Chief Executive Officer of ADMA.

“ADMA now has ten plasma collection centers under its corporate umbrella at various stages, five of which are now FDA-approved to collect normal source and RSV hyperimmune plasma. The Company remains on track to have ten or more of its BioCenters locations FDA-approved by year-end 2023. ADMA’s growing internal plasma collections are currently being supplemented by third-party supply contracts as well as the yield enhancements resulting from the implementation of the Haemonetics’ NexSys Persona® system. We anticipate our encouraging plasma supply position will enable ADMA to continue to expand its customer base and grow revenues in the U.S. immunoglobulin market,” said Brian Lenz, Executive Vice President, Chief Financial Officer, and General Manager, ADMA BioCenters.

No comments:

Post a Comment

Note: Only a member of this blog may post a comment.