Hugel said that the European Medicines Agency (EMA) has granted good manufacturing practice (GMP) certification to its Geodu Plant that manufactures the company's botulinum toxin (BTX) product, Letybo.

Geodu Plant, located in Chuncheon, Gangwon Province, is Hugel's second BTX factory with a production capacity of five million vials a year.

The approval comes after Hugel applied for product approval to EMA to enter the European BTX market in June last year. As part of the approval process, EMA conducted a three-day on-site inspection from Oct. 12- 14 to determine whether the Geodu Plant was suitable for EU GMP certification.

The certification is expected to speed up Hugel’s entry into the European market.

The document review process for EMA approval is now in its final stage, and the company expected that its entry into the huge European botulinum toxin market following China would not be far off.

Besides, the U.S. Food and Drug Administration (FDA) also completed the due diligence for Geodu Plant in September, setting an outline for the company entering the global Big 3 markets – China, EU, and the U.S. – next year, according to company officials.

By adding the Big 3 markets to the existing 28 countries, Hugel aims to grow into a company that covers 95 percent of the global BTX market, realizing its mid- to long-term goal of achieving 80 percent of its sales from overseas.

"Through the two JP Morgan Healthcare Conferences in 2019 and 2020, our company has presented a vision to grow into a global market leader and is smoothly expanding overseas markets," a company official said. "As Hugel's goal of entering the Big 3 BTX market has taken one more step with EU’s GMP certification, we plan to do our best to promote the excellence of K-toxin in the global market."