The Ministry of Food and Drug Safety has ordered a temporary suspension of making and selling six ethical drugs (ETC) by Samsung Pharmaceutical after confirming various violations in making the drugs.
The six drugs include five Samsung Pharmaceutical’s drugs – Geramin, Moarex, Combicin, and Combicin 3.5 and 4 gram – and one Aprogen Pharmaceutical drug, Healthnamine.
The suspension is in accordance with the special inspection conducted by the ministry’s “Good Manufacturing Practice (GMP) Special Planning and Inspection Group,” which confirmed the violations of the Pharmaceutical Affairs Act, such as arbitrarily using additives without permission to change, and creating false manufacturing records, at Samsung Pharmaceutical’s plant.
The ministry has distributed a safety bulletin to doctors, pharmacists, and consumer groups asking for the cooperation of experts in converting the six items into alternative medicines and the products’ proper recall.
The ministry also asked the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service to take measures so that hospitals and clinics do not prescribe the items.
“We will continue to take necessary measures placing top priority on patients’ safety, such as regular year-round inspections of drug manufacturing facilities,” the food and drug safety ministry said.
Samsung Pharmaceutical was unavailable for comments regarding the situation.
The company's stock price tumbled upon the news. As of noon Thursday, the company's share stood at 7,320 won ($6.40), down 14.78 percent from the previous trading day.
Samsung Pharmaceutical has become the latest company punished by the regulatory agency for manufacturing drugs through an illegal process since the latter activated an inspection team to check drugmakers' manufacturing practices in March.
The regulatory move comes after the ministry disciplined Binex and Vivozon for manufacturing drugs using unauthorized methods, such as arbitrarily using additives or fabricating documents to cover up their violations, earlier this year.
In May, the ministry’s GMP inspection Group also suspended the making and selling of six drugs commissioned to HanAll Biopharma after confirming data manipulation.
Meanwhile, a Samsung Pharmaceutical official said the company has no relations with the Samsung Group or its subsidiary, Samsung Biologics.