Binex was suspended from manufacturing all synthetic drugs at its Busan plant due to violating the Pharmaceutical Affairs Act.
Binex maintains that the discipline would have little effect on its marketing. However, given the broad scope of products hit by the administrative disposition, sales losses appear inevitable, according to industry watchers. Binex said it would file an administrative suit against the Busan Regional Food and Drug Administration Office.
Binex has become subject to administrative punishment after it violated good manufacturing practice (GMP) by, for instance, manipulating raw material capacity and manufacturing drugs contrary to permission last year. The latest move seems to be the follow-up step of the violation.
The office ordered Binex to suspend the manufacturing of all products for one month, suspend production of tablets and capsules for one month and seven days, suspend the production of Rofsin Tab. 250 mg (ciprofloxacin) for four months and 15 days, suspend the Daxfen Tab. (dexibuprofen), Amorin Tab. (glimepiride), Xelectin Cap. (fluoxetine), and Xelectin Cap. 10 mg for four months, suspend the production of Dimen Tab. (caffeine anhydrous dimenhydrinate) for four months, and suspend the Cadil Tab. 1 mg (doxazosin) for five months and 15 days.
According to Binex, its sales from the products subject to one month of manufacturing suspension (from Nov. 14 to Dec. 13) total about 74.8 billion won ($54.3 million). The company can replace 23 with fines and continue their production and sales. Also, sales from tablets and capsules for one month and seven days (from Nov. 14 to Dec. 20) total about 50.5 billion won, and the company can replace 26 with fines.
Among the targets of administrative disposition, the manufacturing suspension has already ended for Rofsin Tab. 250 mg, Daxfen Tab., Amorin Tab., Xelectin Cap., and Xelectin Cap. 10 mg. Dimen Tab. will enter into a suspension for four months (from Nov. 14, 2022, to March 3, 2023), but the company can continue its production and sales by replacing the disposition with fines. In the case of Cadil Tab., the company voluntarily withdrew item permission, excluding it from the disposition.
Binex also received a “warning” aside from the manufacturing suspension order from the food and drug safety ministry’s Busan chapter.
"The production stoppage is about the suspension of manufacturing of items, having little impact on the product sales due to the inventory that has been produced so far,” the company said. "However, we will respond to the Busan Regional Food and Drug Administration Office's suspension of manufacturing operations through administrative litigation.”