Author : adminDate : 2021-08-24 15:27

Hwajin, a subsidiary of HLB, gained the U.S. FDA's approval for Sofjec syringes

Sofjec, a syringe produced by HLB subsidiary Hwajin Medical, recently received an approval from the U.S. FDA. Hwajin Medical is a syringe company owned 100% by HLB.

With the spread of the Delta mutation, the number of confirmed coronavirus cases in the U.S. alone surpass 150,000 a day, and the shortage of syringes has long been an urgent issue for the treatment of patients. Particularly, with the first official approval of the Pfizer vaccine on the 23rd (local time), vaccination will be mandatory for faculty and soldiers, and booster shots will be in full swing, which will continue to increase demand for disposable syringes for vaccination. Under these circumstances, Hwajin Medical's ‘Sofjec’ is expected to be highly preferred throughout the U.S. as it is equipped with LDS (low dead space) function to vaccinate more people without wasting vaccines.

Under the approval, Hwajin Medical will be able to supply syringes to the U.S. federal government through AMTC, a U.S. medical device distribution company. Apart from the approval, Hwajin will push for the distribution of ‘Sofjec’ on its own, while also pushing for separate approval to supply the new digital syringe ‘Digital Infusion Pen’, which can be injected remotely. With the FDA's approval for use, the ‘Sofjec’ is expected to be approved quickly in many other countries, including Europe. Currently, export inquiries from European and Middle Eastern countries such as Poland, Oman, Qatar, Spain and Saudi Arabia are surging.

Hwajin Medical plans to expand its production facilities in the near future following FDA approval. Currently, Hwajin produces 15 million syringes per month through GMP (Excellent Drug Manufacturing and Quality Control) certified production facilities.

Lee Woo Jun, the president of Hwajin said "With the FDA's approval, our products, which focused on the domestic market, will be exported to the world including the U.S. in the long term. As Hwajin’s Sofjec is also expected to be used for the COVID19 vaccine 'Nanocovax', which HLB has recently gained the global rights, its growth is likely to continue.”