malaysiang
KUALA LUMPUR, Kolmar BNH immune-boosting health supplement, ‘HemoHim’, has earned international recognition for its quality from both the United States (US) Food and Drug Administration (FDA) and Australia’s Therapeutic Goods Administration (TGA), enhancing its credibility in the global marketplace.
In a statement, Kolmar BNH announced its Sejong plant obtained a No Action Indicated (NAI) classification following an inspection by the US FDA in September.
This classification, which confirms that the facility fully complies with US Current Good Manufacturing Practice (cGMP) standards for quality control, has further intensified Kolmar BNH’s competitiveness as a leading global Original Development Manufacturer (ODM) in the health supplement industry.
‘We are committed to enhancing our competitiveness in global markets through ongoing quality innovation and additional global certifications, with HemoHim at the forefront of our efforts,’ said an official from Kolmar BNH.
The FDA inspection was conducted to eva
luate the company’s quality management capabilities, particularly in response to the increasing exports of HemoHim to the US.
The NAI classification reflects a comprehensive evaluation of key factors, including manufacturing processes, hygiene standards, quality control procedures, and employee training.
Meanwhile, HemoHim’s quality has previously been recognised in Australia, where the Sejong plant obtained Good Manufacturing Practice (GMP) certification from the TGA in 2021.
To meet the Australian TGA’s GMP standards, Kolmar BNH implemented a Standard Operating Procedure (SOP) at the Sejong plant that aligns with international GMP guidelines for pharmaceutical production and quality control.
Building on its success with FDA and TGA certifications, Kolmar BNH plans to expedite HemoHim’s expansion into global markets.
Launched in 2006 and distributed by Atomy, HemoHim is Korea’s first individually approved immune-boosting supplement, made from Korean natural ingredients, with the product currently export
ed to approximately 20 countries.
Source: BERNAMA News Agency
