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USFDA grants Kyongbo Pharm facility approval

June 27, 2016 - 13:40 By Korea Herald
[THE INVESTOR] Korean pharmaceutical giant Chong Kun Dang’s raw materials manufacturer Kyongbo Pharmaceutical has got approval from the US Food and Drug Administration for its sterile GMP facility, its chief executive said June 27. 

CEO Kang Tae-won said the approval was granted to Kyongbo after the company applied for USFDA’s facility clearance evaluation for ceftriaxone, a core ingredient in producing antibiotics for pneumonia and bronchitis, last February. The raw material has already entered Japan and China and is scheduled to enter the US market. 

“We plan to promote our sales in the US market following the approval,” an associate of the company said. “Furthermore, we also plan to get approval from authorities in other overseas markets to target potential ceftriaxone markets, estimated to be US$ 1.4 billion.”

By Jung Min-kyung  (mkj1105@heraldcorp.com)