Korea Pharma Bio Co. said on the 10th that it has developed the nation's first domestically made sodium acetate injection, "Neonatrium Inj.," a national essential medicine, successfully localizing production.
The product received item approval from the Ministery of Food and Drug Safety on the 28th.
Sodium acetate is an essential ingredient used to treat and prevent metabolic acidosis in newborns and children, but because there had been no domestically produced product, Korea had relied entirely on imports. As a result, it was difficult to set stable procurement plans due to fluctuations in supply and drug prices from overseas manufacturers.
Metabolic acidosis refers to a condition in which the acid in the body increases excessively or the ability to neutralize acid declines, causing the blood acid–base balance to break down rapidly.
The company said the approval has established a system that allows more stable supply to medical settings by securing a domestic production base for the sodium acetate injection, moving away from reliance on imports.
Korea Pharma Bio Co. plans to launch Neonatrium Inj. next month. Chair Nam Bong-gil of Korea Pharma Bio Co. said, "Sodium acetate is an essential component in treating metabolic acidosis in newborns and children that is difficult to replace," adding, "Even if the marketability is low, we will continue to invest in indispensable medicines such as national essential medicines."