Kolmar BNH has received endorsement from the US Food and Drug Administration (FDA) and Australia’s Therapeutic Goods Administration (TGA) for its immune-boosting supplement, HemoHim.
The international recognition for its quality is expected to enhance HemoHim’s credibility in the global marketplace.
Kolmar BNH’s Sejong plant received a No Action Indicated (NAI) classification after an FDA inspection in September.
This classification confirms full compliance with the US Current Good Manufacturing Practice (cGMP) standards, enhancing Kolmar BNH’s competitiveness as a global Original Development Manufacturer (ODM) in the health supplement industry.
The FDA inspected Kolmar BNH to assess its quality management considering rising HemoHim exports to the US.
The NAI classification reflects a thorough evaluation of its manufacturing processes, hygiene standards, quality control procedures, and employee training.
HemoHim, a low-acid liquid dietary supplement, showed positive results in extensive tests covering raw material quality, pH levels, and stability.
The product’s quality was previously recognised in Australia, where the Sejong plant received Good Manufacturing Practice (GMP) certification from the TGA in 2021.
The TGA, which regulates pharmaceuticals and health supplements in Australia, grants GMP certification after evaluating product efficacy, safety, and production processes.
To meet the Australian TGA’s GMP standards, the South Korea-based Kolmar BNH implemented a Standard Operating Procedure (SOP) at the Sejong plant, aligning with international pharmaceutical production and quality control guidelines.
The company introduced a real-time production monitoring system and conducted quality tests that surpassed Korean regulatory standards, ensuring defect-free products.
Building on its FDA and TGA certifications, Kolmar BNH aims to accelerate HemoHim’s global market expansion.
In May, the company introduced HemoHim in Taiwan.
A Kolmar BNH official said: “The US FDA’s inspection is a critical benchmark for ensuring product safety and efficacy through a thorough and organised process.
“Receiving a No Action Indicated (NAI) classification is a significant achievement for Kolmar BNH, as it validates the quality of our products on the global stage.”
Launched in 2006, HemoHim is said to be Korea’s first individually approved immune-boosting supplement, made from natural ingredients like Angelica gigas, Cnidium officinale, and Paeonia japonica.
Distributed by Atomy, a key partner, the immune-boosting supplement is exported to about 20 countries, including the US and China.