Huons, a subsidiary of Huons Global Inc., has won an Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration for its 0.9 percent physiological saline injection, company officials said Monday.
Huons휴온스’ 0.9 percent 5mL/10mL physiological saline injection has proved to be biologically equivalent to U.S. pharmaceutical Hospira’s physiological saline injection. It is the first Korean-made finished injection product to receive the FDA approval.
Physiological saline solutions have strict quality standards regarding the production facilities, process, and uniformity, making it difficult to obtain approval from the FDA.
With Huons succeeding in obtaining the ANDA approval from the FDA, the company will be able to export physiological saline injections to the U.S. pharmaceutical market in earnest and is receiving recognition for the quality of their products and injection equipment production facilities, the company said.
Huons will continue to seek to register its flagship products with the FDA, including its lidocaine injections that are currently in the process of being approved.
"We are very pleased to receive the ANDA approval from the FDA for the injection of physiological saline based on the state-of-the-art cGMP facility of the Jecheon plant in Korea,” said Yoon Seong-tae, vice chairman of Huons Global. "We have been actively pursuing new businesses, such as ‘Hutox,’ a costridium botulinum toxin type A injection, following the increase in consignment and overseas exports and the brisk specialty pharmaceuticals business through our business diversification strategy.”
Yoon went on to say, “We will take this opportunity to become a global healthcare company through the successful acquisition of ANDA approval by the FDA.”
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