Pharma Research Bio said it obtained approval from the Ministry of Food and Drug Safety to export its botulinum toxin “Re N Tox” on Friday.
The company has spent four years to develop the botulinum toxin A product.
The government gave the green light to the company’s clinical trial plan in January. The latest export approval provides the drugmaker with an opportunity to conduct a trial and ship the anti-wrinkle product overseas simultaneously.
The ministry’s Good Manufacturing Practice (GMP) inspection on drug manufacturing and quality control confirmed that the company’s factory was optimized for producing botulinum toxin.
“With the export approval, we will begin selling the treatment in Japan. We will also accelerate discussions with global partners including Chinese one to reach a sizable revenue as quickly as possible,” an official at Pharma Research Bio said.
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