Production halted at Korean pharma after regulators find unauthorized additives in 13 drugs
Months after the South Korean pharma Vivozon was ordered to recall and discard 13 drugs after violating good manufacturing practice standards, the Ministry of Food and Drug Safety has ordered suspensions for a number of drugs involved.
Any drugs that were found to have unauthorized additives have been suspended for four months, the Korea Biomedical Review reported Friday. Tablet production is suspended for a month and 29 days, while capsule production was suspended for six weeks, and syrup production for five.
Meanwhile, Vivozon said that it has either withdrawn its permit for the drugs or transferred them to a contract manufacturing organization. Among the drugs involved are Decorafen, Rebadmi, Rebaratin, and Mucopid. Eleven of the 13 will be made at another site.
Vivozon was found to have made drugs with unauthorized additives and bypassed safety testing in December 2021. Samsung Pharma and Binex have been hit with punishments by Korean regulators for similar reasons. The Korean regulatory agencies said last year that it confirmed that the pharma fabricated documents to cover up the use of unauthorized additives.
The company fell victim to the NDMA problem that has plagued pharma manufacturing for the past few years. Regulators recalled 150 mg capsules of Alzatine back in March after there were traces of the cancer-causing agent detected. That followed the recall of two more drugs in January for the same reason.
A number of pharmas have been hit hard by traces of nitrosamines found in their drugs. Pfizer recalled five lots of its blood pressure drug Accupril just this week, as it has been forced to recall several drugs for the same reason. Viona Pharmaceuticals, Sandoz and Nostrum Laboratories all recalled drugs this year for traces of cancer-causing agents.