‘Pharmaceutical raw material manipulation’ spreads the wavelength of Binex… Disposal of a pile of consignment manufacturing items

Input 2021-03-09 16:04 | Revision 2021-03-09 16:04


Binex received an administrative disposition for its products due to the suspicion of manipulating the dosage of raw materials for pharmaceuticals, followed by a large number of consignment manufacturing items.

The Ministry of Food and Drug Safety announced on the 9th that Binex, a pharmaceutical company, will temporarily suspend manufacturing, sales, and recall measures for 32 items manufactured by 24 companies that are entrusted by other pharmaceutical companies.

Earlier, on the 8th, the Ministry of Food and Drug Safety submitted a voluntary recovery plan for six items manufactured by Binex that differed from those approved or reported to the Busan Regional Food and Drug Administration.

In addition, the Ministry of Food and Drug Safety decided to temporarily suspend manufacturing and sales as a precautionary measure.

These six products are ▲ Amorin Tablet (ingredient name glimepiride) ▲ Selectin Capsule (fluoxetine hydrochloride) ▲ Daxfen Tablet (dexibuprofen) ▲ Ropsin Tablet 250 mg (ciprofloxacin hydrochloride hydrate) ▲ Selectin Capsule 10 mg (fluoxetine hydrochloride) ▲ Car Dil tablet 1mg (doxazosin mesylate), etc.

In this regard, the Ministry of Food and Drug Safety initiated an on-site investigation of Binex, and took additional measures on the items that the company consigned to manufacture.

The Ministry of Food and Drug Safety explained, “During the on-site investigation of Binex, it was determined by confirming 32 items of other pharmaceutical companies that were manufactured in the same way as those that had been suspended for manufacturing and sales.”

However, the item subject to this measure is not expected to affect domestic supply and demand as the proportion of production performance is not high.

The Ministry of Food and Drug Safety said, “The safety bulletin has been distributed to related organizations such as medical, pharmacist and consumer agency, asking experts such as doctors and pharmacists to convert the product to other alternative medicines and cooperate so that product collection can be performed properly.”

Meanwhile, the Ministry of Food and Drug Safety plans to promptly complete the Binex site investigation and necessary measures.



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