[Edaily Reporter KIM JI-WAN ] JETEMA Co.,Ltd.(216080)announced on the 21st that its Wonju Plant in Gangwon Province, the company’s main production facility, has successfully passed the final Good Manufacturing Practice (GMP) inspection conducted by Brazil’s National Health Surveillance Agency (ANVISA, hereinafter referred to as ANVISA).
ANVISA is known for its rigorous GMP certification process. To enter the Brazilian market, companies must undergo a strict review of their manufacturing facilities, production processes, and overall quality management systems. Through this inspection, JETEMA Co.,Ltd. confirmed that the production and quality management systems at its Wonju plant comply with ANVISA’s standards.
The Wonju plant, which was the subject of this inspection, is a key production base responsible for the global supply of JETEMA Co.,Ltd.’s botulinum toxin product, “Zetema Dertoxin.”
Building on this successful GMP inspection, JETEMA Co.,Ltd. plans to finalize the Brazilian GMP certification process and then sequentially proceed with follow-up procedures for local product registration.
A JETEMA Co.,Ltd. official stated, “Successfully passing the GMP inspection by Brazil’s ANVISA is a significant achievement that recognizes Onejoon Co., Ltd.’s manufacturing and quality control capabilities as meeting strict global regulatory standards,” adding, “Building on this achievement, we will proceed smoothly with the follow-up procedures for entering the Brazilian market and continue to expand our business foundation in the Latin American market.”
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