Will GC Pharma enter the US blood product market in 2013?
By Chon, Seung-Hyun | translator Kwon Sung-Yong
23.07.18 06:19:02
Reapplying for approval of immunoglobulin to FDA
Ochang plant GMP inspection completed
GC Pharma has challenged the US immunoglobulin blood product market worth 13 trillion won. For the past 13 years since it officially entered the US market in 2010, it has experienced growing pains such as failure to obtain permits and delays, but has attempted to enter the US market again. According to the industry on the 18th, GC Pharma submitted a BLA for its immunoglobulin blood product ALYGLO to the US Food and Drug Administration (FDA). ALYGLO applied for approval for primary immunodeficiency indication. GC Pharma satisfied all efficacy and safety evaluation parameters according to FDA guidelines in the North American phase 3 clinical trial completed in 2020. In the phase 3 clinical trial, ALYGLO was administere
Chon, Seung-Hyun(1000@dailypharm.com)