Posted by Michael Wonder on 17 Jul 2023
Green Cross resubmits BLA for its immunoglobulin blood product to FDA
17 July 2023 - Green Cross said it has submitted a biologics license application to the US FDA for Alyglo, its 10% intravenous immunoglobulin.
According to the company, the FDA conducted a pre-license inspection of the Ochang blood product manufacturing facility in April, which was delayed due to the COVID-19 pandemic last year. The company completed the biologics license application submission last Friday after consultation with the FDA.
