- The FDA has approved ADMA Biologics Inc's ADMA expanded manufacturing process, enabling fractionation and purification of a 4,400-liter plasma pool to manufacture Intravenous Immune Globulin (IVIG).
- The 4,400-liter IVIG plasma pool scale for BIVIGAM will allow ADMA to expand its manufacturing plant's total processing capacity from 400,000 liters to an anticipated peak throughput of up to 600,000 liters.
- Due to the expanded plasma pool production scale, the company now sees peak revenues over $300 million and gross margin expansion beginning potentially in the second half of 2021 and accelerating throughout 2022.
- With this approval, ADMA will now offer BIVIGAM in two vial sizes, both the 50 mL and 100 mL configurations.
- Price Action: ADMA shares are 18.4% at $2.25 in the premarket session on the last check Wednesday.
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