Huons said that the U.S. Food and Drug Administration has approved the company's abbreviated new drug application (ANDA) for bupivacaine hydrochloride in 8.25-percent dextrose injection.
|Huons headquarters in Seongnam, Gyeonggi Province|
With the approval, the company has received three sales approval for its injectable products, following saline injection in 2017 and lidocaine injection in 2018.
"Unlike the two previous approvals, which used the terminal sterilization process to produce the drugs, the most recent ANDA approval is significant as it was produced using the more rigorous and demanding aseptic process," the company said. "The approval has once again shown Huons's excellent production and quality control system."
Bupivacaine hydrochloride injection is one of the company's flagship topical anesthetic injections, and Huons has demonstrated its bioequivalence with Hospira's Marcaine spinal injection 0.75-percent, the company added.
According to the FDA, the 0.75-percent bupivacaine hydrochloride 2mL ampoule has been in short supply since February 2018 due to a steady increase in demand.
Huons plans to quickly expand exports to address local shortages and to bolster its influence in the local anesthetic market with the 1-percent lidocaine injection 5mL, which has already been launched in the U.S.
The company said it also seeks to get sales approval for two local anesthetics injections while applying for U.S. current good manufacturing practice (cGMP).
"The company's top priority, which is quality management through strict procedures, has allowed us to receive approval from the FDA for three consecutive years," Huons Global Vice Chairman Yoon Sung-tae said. "As a result of installing advanced automation equipment and excellent manpower at Huons' plant in Jaecheon, North Chungcheong Province, we will be able to concentrate all our capabilities on becoming a global total healthcare company."