Kolmar BNH Obtains Australian TGA GMP Certification for Eumseong Plant

Kolmar BNH announced on Aug. 16 that its Eumseong plant, located in North Chungcheong Province, has received GMP certification from the Australian Therapeutic Goods Administration (TGA). Previously, Kolmar BNH’s Sejong plant was certified by TGA GMP in 2021. The TGA oversees pharmaceuticals and medical devices in Australia, issuing GMP certifications after a comprehensive assessment of product efficacy, safety, and suitability of the production process.

Drawing on the experience from the Sejong plant’s Australian TGA certification, Kolmar BNH revamped the Eumseong plant system. They established a Standard Operation Procedure (SOP) in line with international GMP standards for finished pharmaceutical manufacturing and quality control, and incorporated domestic pharmaceutical production procedures like annual product evaluation and suitability assessments. Additionally, they implemented a real-time production monitoring system and significantly expanded testing parameters to ensure product quality.

A Kolmar BNH representative stated, “The Eumseong plant has already established its credibility in the global market, producing the ‘Centrum’ multivitamin brand for Helion, a global dry formulation company. With this Australian TGA GMP certification, we plan to accelerate our entry into the global market.”