2020-12-01 07:14:11 ADMA Adma Biologics
12/01/20 12/0107:14 12/01/2007:14 | ADMA Biologics submits BLA seeking approval for third plasma collection centerADMA Biologics announced commencement of operations and initiation of collections at its newest ADMA BioCenters plasma collection facility located in Maryville, Tennessee. ADMA also announced the submission of a Biologics License Application to the U.S. Food and Drug Administration seeking approval for this third plasma collection center. 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. The FDA regulatory process for obtaining approval for this plasma collection center includes a site inspection and an approximately 12-month BLA review period. As such, ADMA expects to receive an approval decision for this third plasma facility in the fourth quarter of 2021. In the meantime, ADMA is permitted to collect plasma donations at this site, and once FDA approved, it can use the plasma collected for production of its FDA approved immunoglobulin products. |
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