[THE INEVSTOR] Kyongbo Pharmaceutical, an affiliate of Chong Kun Dang Holdings, said on Aug. 14 that it was awarded the Good Manufacturing Practice certificate from the French health regulator for its antibiotics facility, paving the way for its overseas business expansion.
The French National Agency for Medicines and Health Products notified Kyongbo that it has passed an audit on the facility and quality system that was conducted in March, according to the company. The plant is located in Asan, South Chungcheong Province.
The audit was the last regulatory hurdle that the company was required to clear to export its cefotaxime and ceftriaxone to France.
“We will further boost the sales of antibiotics active pharmaceutical ingredients to major European countries in the future,” a company official said.
Cefotaxime and ceftriaxone, third-generation cephalosporin antibiotics used in therapies for pneumonia and bronchitis, are Kyongbo’s flagship products that it exports to Japan and China. The global market for the two drug ingredients is valued at around US$2 billion.
The Asan plant had received similar certifications from the US Food and Drug Administration and the European Directorate for the Quality of Medicines in 2016.
By Park Han-na (hnpark@heraldcorp.com)