April 26, 2024

• 

[THE INVESTOR] Daewoong Pharmaceutical said on June 19 it has received a Good Manufacturing Practice certificate from the European Medicines Agency for its facility for self-developed botulinum toxin Nabota in Korea.

The certificate was awarded after the UK’s Medicare and Healthcare Products Regulatory Agency conducted an inspection of the site in Gyeonggi Province in February. 

Daewoong Pharmaceutical factory

Daewoong has been banking on Nabota to make inroads in global markets to compete with other wrinkle fighters, seeking approval in the US, Canada and EU.

With the EU GMP certificate, Nabota is required to clear one major regulatory hurdle -- marketing authorization from the EMA -- for sale in the EU, which accounts for some 30 percent of the global botulinum toxin market. In July last year, the EMA accepted to review the company’s request to approve Nabota.

“We expect a high increase in overseas sales from next year if Nabota obtains marketing authorization in the EU for commercialization,” an official at the firm said.

In May, the company was granted GMP certificate for the plant from health regulators in the US and Canada where the product is currently under review.

By Park Han-na (hnpark@heraldcorp.com)