Hanmi’s eye drop faces 2-month sale ban after failing to submit drug reevaluation data
2023-07-13 Lee Han-soo
Hanmi Pharm received a two-month administrative suspension from selling Eyeporin Eye Drops for failing to submit drug equivalencye test data on July 6, according to the Ministry of Food and Drug Safety.
The treatment is used for ocular inflammation associated with dry keratoconjunctivitis.
Accordingly, Hanmi will not be able to market the product from July 20 to Sep. 19.
This is the second time that the treatment has faced administrative penalties from the MFDS.
In 2020, the MFDS issued a one-month administrative suspension of manufacturing the treatment from Jan. 2 to Feb. 1.
During that time, the company had manufactured and sold the treatment using a different main ingredient but had failed to report such changes.