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ADMA Biologics (ADMA) Receives FDA Approval for its Fourth Plasma Collection Center Located in Goose Creek, SC

January 18, 2022 7:03 AM EST

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 fourth ADMA BioCenters plasma collection facility located in Goose Creek, South Carolina. In conjunction, the facility was issued a compliance certification from the International Quality Plasma Program (“IQPP”), confirming the center meets facility and donor criteria for IQPP Certification. This plasma collection facility commenced operations and initiated source plasma collection in the second quarter of 2021. With today’s approval, this facility is now FDA-licensed to collect and introduce into interstate commerce, human source plasma for further manufacturing in the U.S.

“ADMA is off to an excellent start to 2022 across its business segments, and the approval of the Goose Creek plasma collection center represents another regulatory milestone achievement as well as an important step in ADMA’s ambitions to further secure raw material plasma supply,” said Adam Grossman, President and Chief Executive Officer of ADMA.

“ADMA now has four FDA-approved plasma collection centers, two additional centers operational and collecting plasma, and three additional centers in the planning and construction phases. The successful execution by our BioCenters team positions ADMA to meet or exceed the Company’s target of having 10 or more plasma collection centers FDA-licensed by year-end 2023,” said Brian Lenz, Executive Vice President, Chief Financial Officer, and General Manager, ADMA BioCenters.

“ADMA remains on track towards growing its plasma supply, a commitment that is underpinned by the collective benefits of contractually committed third-party supply agreements, yield enhancements being realized from the implementation of the Haemonetics’ NexSys Persona®, and the aggressive BioCenters expansion strategy. With broader industry plasma collection headwinds anticipated to persist in early 2022 due to COVID-19 and other factors, ADMA believes its uniquely strong plasma supply position will support the continued acquisition of new customers in the in the supply-constrained U.S. immunoglobulin market. We thank the FDA for its efforts and expeditious review of the Goose Creek Biologics License Application (“BLA”), which came well in advance of the agency’s targeted approval date,” concluded Mr. Lenz.

This new, state-of-the-art plasma collection center features automated registration, high-tech collection equipment designed to shorten the donation process, free Wi-Fi wireless network in the donor collection area, individual flat-screen TVs with cable at each donor station, and highly trained and certified staff who put donor comfort and safety first. At full capacity, the plasma center expects to maintain a staff of 50 highly trained healthcare workers. This center is approved to use the state-of-the-art Haemonetics NexSys Persona® plasma collection system.

To learn more about the ADMA BioCenters donation process, and to schedule an appointment, please visit: www.admabiocenters.com, or visit in person at: 214 Saint James Avenue, Goose Creek, S.C. 29445.



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