Hugel, a Korean aesthetics and therapeutics developer, said the European Medicines Agency (EMA) has completed an on-site inspection of its plant in Chuncheon, Gangwon Province, manufacturing its botulinum toxin (BTX) brand, Letybo.

The plant produces more than five million BTX vials a year with the latest automated system to supply the global market.

EMA inspected it from Tuesday to Thursday to determine whether Hugel’s facility meets the European Union’s (EU) standard for good manufacturing practice (GMP).

The company said it expects to acquire EU’s GMP certification without difficulty as the regulator’s inspection proceeded smoothly. Before the EU inspection, the U.S. Food and Drug Administration also conducted a current GMP (cGMP) testing in August, raising the company’s expectations for authorizations for its BTX products in the U.S. and European markets.

Hugel plans to respond to EMA’s feedback on the recent inspection quickly and aims to obtain approval by the end of 2021, speeding up the last step for entering Europe.

The European market, estimated to be worth about 1 trillion won ($845 million), is an attractive field, accounting for 70 percent of the global BTX market combined with the U.S. market.

In 2019, Hugel completed phase 3 Bless 1 and 2 studies with its Austrian partner, Croma-Pharma, in Poland and Germany and applied for approval in June 2020.

The company aims to gain above 10 percent of the market share within three years by targeting young consumers in the U.K., France, Italy, Germany, and Spain, which account for 70 percent of the European market, once Letybo wins regulatory approval.

“With the recently completed EMA’s inspection on our plant, we have taken a step forward to European market following the exports to China which began last year,” a Hugel official said. “We will grow as a global BTX company that can cover 95 percent of the global BTX market by completing inspections by all major regulators this year, including Europe, and entering the U.S. in 2022.”