FDA to inspect Hanmi’s drug manufacturing site in May

The US Food and Drug Administration will carry out a pre-approval inspection in May at Hanmi Pharmaceutical’s drug manufacturing facilities and packaging sites in Gyeonggi Province’s Pyeongtaek that produces the novel drug Rolontis, the Korean company said Wednesday.

The US FDA was slated to approve Hanmi’s manufacturing of the given drug on Oct. 24 last year, but the schedule was temporarily shelved due to restrictions on overseas business trips amid the escalating COVID-19 pandemic.

“Hanmi will exercise its best efforts to get ready for the inspection and receive the commercialization approval from the US,” said Hanmi CEO Kwon Se-chang.

The Korea drugmaker earlier licensed Rolontis to US-based Spectrum Pharmaceuticals in 2012 and the US pharma firm applied to the FDA for an approval, after finishing its three-phase study.

Rolontis is a treatment for Neutropenia, an abnormally low concentration of neutrophils -- a type of white blood cell -- in the blood, making those with the condition more vulnerable to infections.

By Shim Woo-hyun (ws@heraldcorp.com)