Kyungbo Pharmaceutical Hits Upper Price Limit on News of Passing U.S. FDA Production Site Inspection

On March 18, Kyungbo Pharmaceutical hit the upper price limit during intraday trading following news that it had passed the U.S. Food and Drug Administration (FDA) production site inspection.

As of 10:23 a.m. on the same day, Kyungbo Pharmaceutical was trading at 7,130 won on the Korea Exchange, up 29.87% from the previous session.

Earlier that day, Kyungbo Pharmaceutical announced that it had passed the FDA production site inspection after receiving a Voluntary Action Indicated (VAI) rating.

This inspection was conducted at Kyungbo Pharmaceutical's Asan plant in South Chungcheong Province and focused on the production facilities for two products: the fifth-generation cephalosporin antibiotic 'Ceftobiprole,' and the immunomodulatory anticancer agent 'Lenalidomide,' both of which are scheduled for sale in the United States.

The FDA reviewed the plant's manufacturing and process design, quality systems, and raw material management to ensure compliance with cGMP regulations throughout pharmaceutical production. While some areas for improvement in the production process were identified, the FDA determined that they did not have a significant impact on product quality and that no additional regulatory action was necessary, assigning a VAI grade to Kyungbo Pharmaceutical's Asan plant.

This content was produced with the assistance of AI translation services.