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Daewoong renews EU GMP certification for BTX plant
  • By Lee Han-soo
  • Published 2019.11.25 11:55
  • Updated 2019.11.25 15:57
  • comments 0

Daewoong Pharmaceutical said that it has renewed its EU good manufacturing practice (GMP) certification for its Nabota plant. Nabota is the company’s botulinum toxin (BTX) product. Nabota is also known as Jeuveau in the U.S. and Nuceiva in the EU.

Daewoong headquarters in Samsung-dong, southern Seoul.

“The Nabota plant has completed the Finnish Medicines Agency GMP due diligence on quality assurance systems, manufacturing facilities and utilities, and storage from Oct. 16 to 22,” the company said. “Afterward, the company successfully renewed its EU GMP certification by acquiring GMP compliance certification last Wednesday.”

The company completed preliminary due diligence from the U.K. Medicare and Healthcare Products Regulatory Agency for its plant and obtained EU GMP certification in June last year.

According to EU regulations, factories must undergo regular inspections to maintain GMP certification of its manufacturing facilities.

“Our Nabota plant has been recognized for its excellence after a rigorous examination by regulatory agencies in developed countries such as the EU, U.S., and Canada,” Nabota plant manager, Kim Joon said. “We are producing and managing products that meet global standards through superior manufacturing facilities and advanced quality management systems based on the plant's state-of-the-art automation equipment.”


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