Binex, a Kosdaq-listed biopharmaceutical CDMO, has been subjected to a two-month suspension of sales operations for Bimo 5mg (ingredient: minoxidil), a hair loss treatment, for failing to submit necessary documents for the 2023 drug equivalence reevaluation.

The product in question will not be available for sale from March 11 to May 10.

The decision was made following the company's non-compliance with the requirements set forth under the Pharmaceutical Affairs Act.

This is not the first time that Binex has faced administrative penalties.

The Ministry of Food and Drug Safety is also investigating media reports after a former employee of Binex claimed that he had reported bacterial detection in the eye drop production line at the company's Busan plant, but no significant actions were taken.

The employee also alleged data manipulation during the production process and drug efficacy checks whenever issues arose.

The company also previously came under fire in March 2021 for illegal drug manufacturing practices, including manipulation of the active pharmaceutical ingredient dosage and manufacturing methods, which led to a suspension of its manufacturing operations.