April 24, 2024

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[THE INVESTOR] Concerns over Celltrion having received a Form 483 from the US Food and Drug Administration is disproportionate, said eBEST Investment and Securities on Aug. 8, maintaining a “buy” recommendation and 450,000 won (US$402.14) target price. 

FDA has issued a warning letter, noting an issue related to vial stoppers, in January and did a follow-up inspection last month. The company stated that this Form 483, or Notice of Inspectional Observations, is unrelated to the contents of warning letter, hinting that the level of inspection will be advanced to Voluntary Action Indicated from Official Action Indicated. 

Celltrion is holding talks with FDA to draw a conclusion by mid-August and VAI classification, if granted as presumed, will not pose any problem in gaining an approval for applications, said analyst Shin Jae-hun.

The fast-track status of its global CMO partner Teva’s drug candidate remains unchanged as well, added the analyst. 

By Hwang You-mee (glamazon@heraldcorp.com)