The regulator ordered multinational pharmaceutical firms, including MSD Korea, to suspend drug imports after the companies failed to comply with the local safety regulations.
The Ministry of Food and Drug Safety ruled that Ferring Pharmaceuticals Korea, MSD Korea, and Merz Korea would be banned from importing some of their drugs for two weeks, a week, and a month, respectively.
Ferring Korea did not receive approval for change of manufacturer even though it changed the manufacturer of the main ingredient of Propess Vaginal SR Tab. (ingredient: dinoprostone).
Propess Vaginal SR Tab. is used for induction of a pregnant woman’s delivery. A drugmaker must obtain the ministry’s permission to change the manufacturer of the main ingredient, which affects product quality.
The ministry ordered a 15-day suspension of the import of Propess Vaginal SR Tab. from July 9-23.
MSD Korea imported Stocrin Tab. (Efavirenz) without reflecting the changed approval condition to the drug label and released it in the local market. Stocrin Tab. (Efavirenz) is a drug for the treatment of HIV-1 infection and is administered in combination with other antiretroviral drugs.
The ministry suspended the import of Stocrin Tab. for a week from July 9-15.
Merz Korea is banned from importing Xeomin Inj., botulinum toxin, for a month from July 2 to Aug. 1. The company had to receive state shipment approval by the serial number but applied for approval three days after the drugs passed the customs.
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