Daewoong Pharmaceutical said Tuesday that it has received good manufacturing practice (GMP) certification from the European Medicines Agency (EMA).

The plant, which can produce up to 4.5 million vials of Nabota a year, is equipped with state-of-the-art production facilities and an advanced quality control system, Daewoong said.

The approval comes after Daewoong submitted a marketing authorization application to EMA through a centralized procedure last June and filed a license application in July. The EMA carried out due diligence on the Nabota Plant located in Gyeonggi Province for five days from Jan. 29 to Feb. 2.

U.K.’s Medicare and Healthcare Regulatory Agency (MHRA) inspected Daewoong’s plant. This is the first time that a local biopharmaceuticals company passed MHRA inspection.

“The U.K. MHRA is known to have a high-level and demanding investigation process among European regulators, which makes the EU GMP approval more meaningful,” said Park Sung-soo, head of Daewoong’s Nabota business division. “If Nabota acquires the European sales license as it has done in the U.S. and Canada, the company expects overseas sales will increase significantly next year.”

Europe is the second-largest drug market in the world, followed by the United States, with a market share of 25-30 percent in the botulinum toxin market, too.