Daewoong Pharmaceutical said on Nov. 25 that its Nabota plant has renewed its EU GMP certification from the European Medicines Agency (EMA).
The Nabota plant completed due diligence on GMP by the Finnish Medicines Agency (Fimea) for five days from Oct. 16-22 on all manufacturing facilities and quality control, including quality assurance systems, manufacturing facilities, utilities and storage.
It succeeded in renewing its EU GMP certification by obtaining a GMP-compliant certificate on Nov. 20.
The Nabota plant successfully completed a preliminary inspection by the British Medicare and Healthcare Products Regulatory Agency (MHRA) early last year and was certified as an EU GMP in June last year.
"The Nabota plant has been recognized for its excellence after rigorous screening by EU GMP, U.S. FDA cGMP, and Canadian GMP. We produce and manage products that meet global standards through superior manufacturing facilities and advanced quality management systems based on state-of-the-art automated facilities," a Daewoong Pharmaceutical official said.
Meanwhile, the botulinum toxin product, developed and manufactured by Daewoong Pharmaceutical, won an item license from the European Commission in September under the name of "Nuceiva," and is set to be released in 31 European countries in 2020.