[Asia Economy Reporter Hyungsoo Park] HLB Therapeutics announced on the 16th that its subsidiary Hwajin Medical's syringe "Sofjec" has received sales approval from the U.S. FDA. Hwajin Medical is a medical device manufacturer wholly owned (100% stake) by HLB Therapeutics.
In August 2021, Hwajin obtained sales approval for Sofjec through AMTC, a U.S. medical device distribution specialist. This is the first time Hwajin has been directly approved by the FDA. Hwajin currently exports syringes to countries including the U.S., Saudi Arabia, Vietnam, and Mongolia, as well as domestically.
To handle the rapidly increasing order demand, Hwajin is in discussions with its affiliate HLB Life Science's Medicare Division to expand production capacity. Top 10 pharmaceutical companies by sales have requested supply volumes from Hwajin.
Sofjec enhances safety compared to conventional syringes. In medical settings, when drawing medicine from glass ampoules using syringes, incidents can occur where tiny glass shards or rubber fragments from the ampoule enter the syringe. The Sofjec membrane syringe is equipped with a filter paper on the needle to block such harmful substances in advance.
A Hwajin Medical official stated, "Even after the COVID-19 pandemic, the syringe market continues to grow due to the increasing global elderly population and chronic disease patients such as those with hypertension and diabetes," adding, "We will strive to supply syringes stably worldwide, including the U.S."
According to a report by Allied Market Research, the global functional syringe market is projected to grow from $6.872 billion in 2019 at an average annual growth rate of 8.7%, reaching $14.1855 billion by 2027.
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