Huons Global said that the Ministry of Food and Drug Safety has granted the Korean good manufacturing practice (KGMP) certification to its second manufacturing plant for Hutox, the company's botulinum toxin (BTX) product,
|Huons headquarters in Seongnam, Gyeonggi Province|
According to the company, its second BTX plant was constructed to match the production capacity and advanced system for entering the global market, including the U.S. and Europe. The plant can produce six million vials per year, six times higher than the first plant's production capacity of one million vials.
"Huons Global plans to achieve excellent performance in the Korean and global BTX market by flexibly responding to local and overseas demand based on increased production capacity," the company said in a press release.
Huons Global has been exporting Hutox to several countries, including Japan, the Middle East and Southeast Asia, as well as signing large-scale export contracts, promoting local clinical trials, and applying for sales approval with countries in Europe, China, and Latin America last year.
The company also plans to sign contracts with major countries, such as the U.S., to increase its influence in the global BTX market.
In Korea, the company will focus on aesthetics aspects, such as wrinkle improvement, through Humedix based on the improved production capacity. It will aim to rapidly expand the indications for the drug to strengthen its competitiveness. Hutox has already won approval to treat forehead wrinkles.
To this end, the company is conducting phase 3 clinical trial for eye wrinkles and phase 1 clinical trial for treating upper extremity muscle stiffness after stroke. Also, the company will apply for an investigational new drug (IND) to treat square jaws soon.
"With the expansion of the second plant, which has GMP levels to cope with local and overseas needs, the company will be able to respond to global demand flexibly," Huons Global CEO Kim Wan-sup said. "Starting in 2020, our company will increase sales based on enhanced productivity."