Medytox said on the 22nd that its affiliate Numeco won product approval on the 19th from the Ministery of Food and Drug Safety for the botulinum toxin product "NEWLUX injection 200 units (Clostridium botulinum toxin type A)."
NEWLUX is a lyophilized botulinum toxin product that Numeco developed after receiving a transfer of next-generation toxin candidate technology from Medytox.
According to the company, applying the latest manufacturing process has improved Production yield and quality. The company said that among 900 kDa (kilodalton) products, it is the first to use only non-animal media in the strain culture process, reducing the risk of contamination from animal-derived components.
The newly approved NEWLUX injection 200 units has the same formulation and indications/effects as the NEWLUX injection 100 units approved in Korea in 2023, but doubles the active ingredient content. Production is set to take place at Medytox's Osong Plant 3, Building E.
A Numeco official said, "Through domestic product approval for this 200-unit product, we have laid the groundwork to strengthen competitiveness in future global approvals and export expansion," adding, "We will continue to enhance the NEWLUX brand value based on differentiated quality competitiveness and research and development capabilities."