The Ministry of Food and Drug Safety initiates administrative disposition on items manufactured differently from license requirements
Possibility of additional administrative disposition depending on the results of the factory investigation
The Ministry of Food and Drug Safety (Director Kang-rip Kim) announced that some items of Binex, which produced pharmaceuticals in a manner different from the approved manufacturing method, may be temporarily suspended from manufacturing and sales, and that the number of target items may increase.
The Busan Regional Food and Drug Administration started an on-site investigation on Binex’s manufacturing plant yesterday (8th), and stopped manufacturing and selling six products with problems, and carried out collection and disposal.
An official from the Ministry of Food and Drug Safety said, “The recovery measures for 6 drugs manufactured differently from the currently reported manufacturing method have been carried out as of the 8th.” “Recovery operations such as front-line pharmacies will take place in earnest,” said an official from the Ministry of Food and Drug Safety.
He added, “Currently, we are investigating whether there is a safety problem with drugs produced by other manufacturing methods,” he said. “Because the number of products is large and investigations are underway across the manufacturing plant, it will take some time for the results of the investigation on safety to come out.”
Currently, a total of 7 generic drugs are being produced at Binex’s Busan Plant 1, which is currently undergoing field investigations, and interest is drawing on whether it will lead to additional administrative measures.
Among the products produced by this factory, items that are not subject to administrative disposition are ▲Neuroxacin tablet of Guju Pharmaceutical (ciprofloxacin hydrochloride hydrate) ▲Lopesin tablet of Binex 250mg (ciprofloxacin hydrochloride hydrate) ▲Cho-A Pharmaceutical’s ciflocq tablet 250mg (ciprofloxacin hydrochloride hydrate) ▲ Jinyang Pharmaceutical’s siroxin tablet 250mg (ciprofloxacin hydrochloride hydrate) ▲Icure’s siroktan tablet 250mg (ciprofloxacin hydrochloride hydrate) ▲Hana Pharmaceutical’s cipron tablet 250mg (ciprofloxacin hydrochloride hydrate) ▲Punglim Mujae’s Poonglim Ciprofloxacin Hydrochloride hydrate 7 products to be.
An official from the Ministry of Food and Drug Safety said, “Currently, we have conducted an on-site investigation for the plant one day. We will continue to conduct field investigations to check whether there are any additional violations of the Pharmaceutical Affairs Act.”
“According to the results of the survey, administrative disposal items can be concluded with the current six items, and if additional problems are found, the number of items subject to an increase can be made.”
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