Binex’s arbitrary dosage of main raw materials for pharmaceuticals and manipulation of manufacturing methods continues. The Ministry of Food and Drug Safety has temporarily suspended the manufacture and sale of Binex’s consignment manufacturing items along with the on-site investigation, and it will be decided whether or not to continue the sale of these items according to the results of the investigation by the Ministry of Food and Drug Safety in the future.
Binex side was optimistic about the situation due to reasons such as voluntary reporting and sales volume, but it is not easy to point out that this situation clearly shows the lack of drug safety management due to the outsourced life.
Regarding this controversy, the Ministry of Food and Drug Safety (FDA) temporarily suspended manufacturing and sales on six items that had a problem with changing the raw material capacity and manufacturing method on the 8th, and on the 9th, the 32 items that Binex had commissioned from other manufacturers to produce were tentatively made. Designated as a target for suspension of manufacturing and sales.
The Ministry of Food and Drug Safety also began an investigation on the site of the Busan factory that triggered the incident on the 8th.
Accordingly, Binex is in a position that there will be no expansion of items subject to disposal as it voluntarily reported six items that may have problems through its own investigation to the Ministry of Food and Drug Safety.
A Binex official said in a call with this magazine, “We are accepting the disposition of the Ministry of Food and Drug Safety such as suspension of sales, and we are watching what decisions will be made after the investigation.”
In addition, Binex predicted that as the sales of these products are not large, the impact of the suspension of sales this time will not be very large.
According to the contents of Binex’s voluntary disclosure on the 8th, the total sales of six items (including consignment products) for which the Ministry of Food and Drug Safety decided to temporarily suspend manufacturing and sales and take measures were about 2.5 billion won, and sales as of 2020 (approximately 132.9 billion won). ) Of 1.88%.
The official said, “We expect that there will be no sharp problems with other pharmaceutical companies.”
The pharmaceutical companies that have entrusted the manufacture of drugs to Binex in relation to the Binex incident are observing the results of the investigation by the Ministry of Food and Drug Safety.
A pharmaceutical company that sells an item that has been temporarily suspended from manufacturing and sales by the Ministry of Food and Drug Safety said, “It seems that it is not yet a step to take action (the pharmaceutical company that consigned the generic).
Another pharmaceutical company official asked, “Isn’t it necessary to ask Binex how to deal with consignment companies?”
Another pharmaceutical company official who refused to disclose the name of the company said, “We have not been informed of this incident and the temporary suspension of sales of consignment items from Binex.” It is difficult for me to make a plan.”
Some say that this situation is serious enough to simply cut the scale of sales as Binex claims. It is pointed out that the blind spot of the foster caregiver’s management has been revealed.
An official in the pharmaceutical industry pointed out, “It is an old-fashioned behavior that could only exist in the 1970s, before the standards for drug manufacturing management were established.”
The Korean Pharmacopoeia also issued a statement on the 9th and pointed out that the KFDA’s suspension of manufacturing and sales of 6 drugs of Binex and review of the consignment production generics of the relevant items was a precautionary measure.
The Korean Pharmaceutical Association said, “In a CMO pharmaceutical company specializing in consignment production of pharmaceuticals, manufacturing process control and quality control are the core of management, and the minimum moral obligations of pharmaceutical companies that produce pharmaceuticals.” It is a misunderstanding caused by the manufacturing process of synthetic drugs, and it is argued that there is no problem with the consignment production of the Corona 19 vaccine.”
“This is by no means a problem for Binex alone. In the name of fostering K-Pharmaceuticals, the nation’s new growth engine, we will have to look back on the reasons for the existence of the KFDA, which neglects quality control while operating an unlimited consignment biotechnology and joint development system.”
The Korean Pharmacopoeia urged the Ministry of Food and Drug Safety to face public anxiety and suspicion over the overall pharmaceutical products and to check the quality control of pharmaceutical products at all manufacturing sites.
On the other hand, the Ministry of Food and Drug Safety designated 32 items from 24 companies as targets for temporary suspension of manufacturing and sales on the 9th.
Antipyretic and analgesic drug Daxfen tablet (ingredient name dexibuprofen) for consignment manufacturing items ▲ Decfen tablet (Kyungbo Pharmaceutical) ▲ Dicarol tablet (Ildong Pharmaceutical) ▲ Sony Pen tablet 300mg (JW new drug) ▲ Exifen tablet (Hanall Biopharma), etc. 4 It is an item.
Antimicrobial drug Ropesin Tablet 250mg (ingredient name Ciprofloxacin Hydrochloride Hydrate) In the case of consignment manufacturing items ▲Neuroxacin Tablet (Guju Pharmaceutical) ▲SiflocQ Tablet 250mg (Cho-A Pharmaceutical) ▲Siroxin Tablet 250mg (Jinyang Pharmaceutical) ▲Siloctan Tablet 250mg (Icure) ▲CIF Ronjeong 250mg (Hana Pharmaceutical) ▲ Poonglim ciprofloxacin hydrochloride hydrate tablet (Punglim Mujae).
Antidepressant Selectin Capsule (ingredient name fluoxetine hydrochloride) In the case of consignment manufacturing items ▲Diffmax Capsule 20mg (Light Pharmtech) ▲Slicetin Capsule (Dongkuk Pharmaceutical) ▲Young Proctin Capsule (Youngpoong Pharmaceutical) ▲Oxetine Capsule (Cho-A Pharmaceutical) ▲Oxygreen Capsules (Mothers Pharmaceuticals) ▲ Wellfit Capsules (Woori Pharmaceutical) ▲ Unijak Capsules 20mg (Unimed Pharmaceuticals) ▲ Ponoxetine Capsules 20mg (JW New Pharmaceuticals) ▲ Purcetin Capsules 20mg (Mirae Pharmaceuticals) ▲ Phloxen Capsules (Hoil Pharmaceuticals) ▲ These are 11 items including pronin capsules (CMG Pharmaceuticals).
Selectin capsule 10mg (fluoxetine hydrochloride) In the case of consignment manufacturing items ▲Slicetin capsule 10mg (Dongkuk Pharmaceutical) ▲Young Proctin capsule 10mg (Youngpoong Pharmaceutical) ▲Obetin Capsule (Introbio Pharma) ▲Oxetine Capsule 10mg (Cho-A Pharmaceutical) ▲ Wellfit Capsule 10mg (Woorideul Pharmaceutical) ▲ Unijak Capsule 10mg (Unimed Pharmaceuticals) ▲ Pronin Capsule 10mg (CMG Pharmaceuticals) ▲ Floctin Capsule 10mg (Genuine One Science) ▲ Flumin Capsule 10mg (Taegeuk Pharmaceutical), etc. 9 It is an item.
In the case of diabetes treatment Amorin tablet (ingredient name Glimepiride), there are two items: ▲ Grill tablet (SPC) ▲ Gluvi tablet (Alvogen Korea).
Of the six items, the hypertension drug Cadillac 1mg (ingredient name doxazosinmesylate) was not designated as a separate item because there was no contract manufacturing record.