MFDS Temporarily Suspends Manufacture and Sale of Dongkoo Bio & Pharma's 'Roxolis'

The Ministry of Food and Drug Safety announced on the 27th that it has decided to impose a provisional suspension of manufacturing and sales, as well as a recall, on Donggu Bio Pharmaceutical for manufacturing and selling pharmaceuticals differently from the approved specifications, and distributed a related drug safety alert.

Exterior view of Donggu Bio Pharmaceutical Hyangnam Plant

This measure was taken for two products: the non-steroidal anti-inflammatory drug Loxoris tablets and the diabetes treatment drug Gliphaem tablets. The Ministry of Food and Drug Safety explained that after inspecting Donggu Bio Pharmaceutical’s compliance with Good Manufacturing Practice (GMP) standards, it confirmed violations of the Pharmaceutical Affairs Act, such as arbitrarily changing additives and manufacturing differently from the approved specifications, and falsifying manufacturing records to appear as if they were produced according to the approved specifications.

This suspension of manufacturing and sales will remain in effect until Donggu Bio Pharmaceutical completes necessary safety measures such as recalls and product approval changes. Subsequently, to verify the quality appropriateness of the two products, tests and inspections will be conducted at testing institutions designated by the Minister of Food and Drug Safety, and the results must be submitted.

Additionally, through the drug safety alert, medical professionals are advised to suspend prescribing and dispensing the affected products, patients currently taking them are urged not to stop taking them arbitrarily but to consult with doctors or pharmacists, and doctors and pharmacists are requested to cooperate to ensure the prompt recall of the related products.