The Ministery of Food and Drug Safety said on the 13th it ordered a three-month suspension of sales operations for the anti-inflammatory painkillers Ifpen tablets and Ifpen W tablets, manufactured and sold by Korea Syntex Pharmaceutical.
According to the Ministery of Food and Drug Safety, Korea Syntex Pharmaceutical received an administrative disposition on the 27th of last month after it was confirmed that the labeling on the product container differed from the approved or filed information. The disposition period runs until July 9.
Korea Syntex Pharmaceutical had previously received an administrative disposition in December last year for violating Good Manufacturing Practice (GMP). At the time, for reasons including failure to conduct raw material quality tests, failure to validate cleaning according to the company's own manuals, and failure to conduct stability tests, 58 items were ordered to suspend manufacturing operations for three to four months.
In November 2023, it was found to have manufactured drugs by arbitrarily adding an excipient and received a disposition canceling its GMP compliance determination, and in April 2024, it became a second cancellation case after it was confirmed to have arbitrarily changed an excipient during manufacturing without filing a change report. The company filed an administrative suit against the disposition but lost in the first trial and is known to have accepted the ruling afterward.