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FDA greenlights Celltrion HIV drug manufacturing facility in South Korea

Published on 16/03/20 at 10:23am

South Korean biopharma firm Celltrion has revealed that one of its key manufacturing facilities has been given the all-clear by the FDA following an on-site inspection in January.

The visit to the site in Cheongju, the largest city in the nation’s North Chungcheong Province, was for an additional inspection in order to review new technology which was omitted in the facility’s most recent Current Good Manufacturing Practice (CGMP) report, with the FDA finding no issues requiring intervention.  

 The US regulator has since postponed its overseas inspection in light of the ongoing global coronavirus pandemic.

Among the products manufactured at the facility is the drugmaker’s three-in-one oral treatment for HIV, known as CT-G07, which is currently awaiting approval from the FDA for commercialisation in the US. Celltrion is hoping for a decision as early as April this year.

Matt Fellows

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