ADMA Biologics Inc (NASDAQ: ADMA) has announced approval from the U.S Food and Drug Administration (FDA) to change the BIVIGAM and ASCENIV immune globulin’s (IG) expiration date to 36 months from 24 months when stored between 2°C and 8°C.
This conviction is similar for all BIVIGAM and ASCENIV drug products, whether they are now in the market or not. It also applies to external and internal finished products, different production scales, and vial sizes.
Benefits of the extension to the company
According to ADMA’s CEO and President, Adam Grossman, this change allows pharmacies and other providers to have more flexible inventory and utilization management. It also allows the company to have a better cycle of net working capital.
Grossman adds that the extension of the expiration date is proof that ADMA Biologics creates quality and stable medication that meets all regulators’ requirements. It also shows that ADMA has an efficient manufacturing process.
Moreover, it shows the company’s dedication to the current regulatory standards, which was met by its top supply chain, production, quality, compliance, and regulatory teams.
The change will enable the company to compete in the market
ADMA has assured patients and doctors that the expiration extension is now in effect to help them make more informed decisions about the best medications.
Grossman believes that the change will allow the company to keep up with its competition and give customers one more reason to choose it over other medications. It will also enable the company to better penetrate the market with ASCENIV, BIVIGAN, and other immune globulin therapies and service patients and doctors worldwide.
ADMA Biologics is a pharmaceutical company that focuses on developing, marketing, and manufacturing therapies for patients with immunodeficiency and those at risk of certain diseases.
Its portfolio includes three medications that the FDA has approved. These are NABI-HB, ASCENIV, and BIVIGAM. ASCENIV treats primary humoral deficiency disease. BIVIGAM not only treats the same illness but also various genetic conditions such as congenital agammaglobulinemia.
Furthermore, it makes IG products at a purification fractionation facility, Boca Raton. The facility, which is in Florida, has received licensing from the FDA.
