US FDA Approves ADMA Biologics Inc’s (NASDAQ: ADMA) Extended Manufacturing Process to Produce IVIG

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ADMA Biologics Inc (NASDAQ: ADMA) announced US FDA approval for its expanded manufacturing process. It allows the company to manufacture IVIG (Intravenous Immunoglobulin) from a pool of purified plasma of 4,400 liters.

FDA approval meets requirements for IVIG in the United States

ADMA CEO Adam Grossman said receiving FDA approval for the purification of a 4,400 liter plasma pool for the manufacture of IVIG is an important milestone. It enables the company to increase production of IVIG and meet demand from patients with immune deficiencies and in the United States.

Expected revenue of $ 300 million

ADMA expects to achieve revenues of over $ 300 million from the expanded plasma pool. It strengthens gross margins in H2 2021 and accelerates in 2022.

With FDA approval, ADMA expands its total processing capacity to 600,000 liters, up from 400,000 currently. It will use the same equipment, labor, disposables, and the same release test tests and maintain high quality. ADMA can now supply BIVIGAM in 100ml and 50ml configurations.

Live conference call

ADMA will release its financial results for the first quarter of 2021 on May 12, 2021, after the close of hours in the United States. ADMA’s leadership team will host a live conference call on May 12, 2021 at 4:30 p.m. ET to discuss company updates and financial results.

Inaugurates a plasma collection facility in SC

ADMA inaugurated its BioCenters donor plasma collection center in Goose Creek, SC

Grossman said the company is happy to open its plasma collection center in South Carolina. He is also grateful for the support provided by Henry McMaster, Governor of South Carolina, and his staff.

It can safely collect plasma using skilled manpower and impressive infrastructure in the state. The company will also expand its operations in South Carolina in the future.

ADMA operates seven plasma collection centers under the corporate brand, and they are in various stages of development and approval. It aims to maintain ten plasma collection centers in 2024.

Grossman added that securing raw materials is essential. The expansion of BioCenters is expected to improve QoQ revenues in 2021 and beyond. He said the supply of products to customers is not wavering and is generating significant value for investors. The company must find sponsors for the collection of plasma donations three months before applying for a BLA.


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