Hugel’s Botulax and Pharma Research Bio’s ReNTox
Shares of Kosdaq-trading Hugel and Pharma Research Bio crashed Thursday after the Korean drug authority announced it was revoking their license in six botulinum toxin products for violating certification and shipping regulations.
The Ministry of Food and Drug Safety announced on Wednesday it was cancelling licenses on six botox products for unauthorized shipment. The six botox products -- two dose types of Pharma Research Bio’s ReNTox and four types of Hugel’s Botulax -- will be immediately recalled and seized for destruction.
The ministry also ordered a six-month manufacturing suspension for Pharma Research Bio, as the company was found to have sold two botox products in the local market without proper approval for domestic sales.
Under the Pharmaceutical Affairs Act, companies should seek lot release certificates for the sale of biologic products that require caution when using and storing.
The health authorities issued a drug safety communication to healthcare professionals, asking for their cooperation in replacing and recalling the six botox products.
Hugel, the country’s leading botox products maker said it would fight the ministry’s move, saying their products were not subject to the regulation because they were produced for overseas sales.
Hugel shares plunged 10.9 percent to close Thursday at 130,000 won and Pharma Research 1.49 percent to 79,200 won in Seoul.
By Kim Si-gyun and Minu Kim
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