Daewoong Pharmaceutical said Thursday that it has received good manufacturing practice (GMP) certification from the Canadian government.

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 the of Canadian federal health department inspected the company’s factory from May 14 to 18. The company received the certification on May 18.

Daewoong has also filed an NDS (New Drug Submission) application for Nabota to Health Canada in July of last year. The Canadian authorities had accepted the filing in October.

Canada's GMP approval is one of the major screening procedures that companies must pass to receive drug approval. The GMP certification has ensured that the company’s plant complies with the Canadian drug production facility regulations and produces and manages pharmaceuticals safely and systematically.

Canada, a G7 member, is the fifth member to register at the International Commission on the Regulation of Medicines (ICH), after the U.S., EU, Japan, and Switzerland.

“The company has succeeded in acquiring GMP certifications from Canada and U.S. after systematically preparing for the certification,” said Park Sung-soo, head of Daewoong’s Nabota business division.

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