ADMA Biologics Inc. (NASDAQ: ADMA) has announced that US FDA has approved its fourth ADMA BioCenters plasma collection facility in Goose Creek, South Carolina.
Plasma gathering facility commenced operation son Q1 2021
In addition, the International Quality Plasma Program (“IQPP”) provided a compliance certification to the facility, certifying that it satisfies the facility and donor standards for IQPP Certification. In Q1 2021, this plasma gathering facility began operations and began collecting source plasma. Now, the facility is FDA-licensed to receive and bring human source plasma into interstate commerce for further production in the United States, thanks to today’s approval.
CEO and President ADMA Adam Grossman said, “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.”
ADMA BioCenters CFO, General, and EVP Brian Benz stated, “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.”
ADMA on track to grow plasma supply
Lenz added, “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 US 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.”
