Posted by Michael Wonder on 28 Feb 2022
GC Pharma receives complete response letter from the U.S. FDA for Alyglo
27 February 2022 - GC Pharma today announced that it has received a complete response letter from the U.S. FDA in response to its biologics license application for Aklyglo (immunoglobulin (human), 10% liquid).
The FDA recommended a pre-license inspection of GC Pharma Ochang facility in order to support approval of the Company’s application.
