On the 9th, Binex, which manufactured drugs differently from the approval requirements, received provisional suspension of manufacture and sale of 32 items (24 companies) of contract manufacturing drugs and withdrawal from the Ministry of Food and Drug Safety on the 9th. This is an additional measure in addition to the six items of Binex announced by the Ministry of Food and Drug Safety.
The Ministry of Food and Drug Safety announced that it has identified 32 items of other pharmaceutical companies that are manufactured in the same manner as six items during the on-site investigation of Binex.
Specifically, 4 items including dexibuprofen component ▲Decken tablet ▲Dicarol tablet ▲Sonyfen tablet 300mg ▲Excifen tablet, and ciprofloxacin hydrochloride hydrate component ▲Nuroxacin tablet ▲Sifloxine tablet 250mg ▲Cyroxine tablet 250mg ▲Siloctan tablet ▲Ceflon tablets 250mg ▲Punglim ciprofloxacin hydrochloride hydrate tablets and 6 other items.
In addition, fluoxetine hydrochloride component ▲Diffmax Capsule 20mg ▲Slicetin Capsule ▲Young Proctin Capsule ▲Oxetine Capsule ▲Oxygreen Capsule ▲Well Fit Capsule ▲Unique Capsule 20mg ▲Ponoxetine Capsule 20mg ▲Frucetin Capsule 20mg ▲Floxen Capsule ▲ 11 items including pronin capsules, ▲ slycetin capsules 10mg ▲ young proctin capsules 10mg ▲ obetin capsules ▲oxetine capsules 10mg ▲wellfit capsules 10mg ▲unizac capsules 10mg ▲pronin capsules 10mg ▲floctin capsules 10mg ▲ 9 items, including 10mg of flumine capsules, and 2 items including glimepiride ingredients, ▲ grilled tablets and ▲ glutinous tablets.
On the 8th day, Vinex’s ▲Daxfen tablet (ingredient name dexibuprofen) ▲Ropesin tablet 250mg (ingredient name ciprofloxacin hydrochloride hydrate) ▲Selectin capsule (ingredient name fluoxetine hydrochloride) ▲Selectin capsule 10mg (ingredient name fluoxetine hydrochloride) ▲Amorine tablet (ingredient name Glimepiride) ) ▲Cadyl tablets 1mg (ingredient name doxazosinmesylate), etc. 6 items have been subject to administrative disposition.
Among them, there is no record of consignment manufacturing of Doxazosin Mesylate-based drugs by Binex.
The Ministry of Food and Drug Safety said, “The safety bulletin has been distributed to related organizations such as doctors and pharmacists so that medicines and pharmacists can convert the product into alternative medicines and retrieve the product properly. · We requested a restriction on the prescription of the product in the clinic, etc.,” he said.
He added, “As the proportion of production performance is not high for the items to be taken, it is expected that there will be no impact on domestic supply and demand.”
In fact, a number of items existed as a result of looking at drugs with the same ingredients as those taken through the KPDA.
First of all, the dexibuprofen-based drugs include Anguk Pharmaceutical’s’Anifen Tablet 300mg’ and Hanmi Pharmaceutical’s’Maxibufen® Tablet 300mg’. 250mg’, etc.
The fluoxetine hydrochloride component and glimepiride component pharmaceuticals include Myeongin Pharmaceutical’s’Furoctin Capsule’ (10mg, 20mg) and Handok’s’Amaryl Tablet 2mg’, respectively.
