Gov't pulls license of six botulinum products

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Gov't pulls license of six botulinum products

The Ministry of Food and Drug Safety will revoke the license of six botulinum toxin products manufactured by Hugel and Pharma Research Bio for violating certification and shipping regulations.
The products include four items of Hugel’s botulinum toxin products and two items of Pharma Research Bio. The drug safety authorities said it caught the two companies selling the items in the domestic market without gaining approvals. Botulinum toxin is popularly known by the Botox brand name.
Under Korea’s Pharmaceutical Affairs Act, companies must receive certificates from the Ministry of Food and Drug Safety in order to sell them on the domestic market.
The licenses will be cancelled on Dec. 13.
The ministry also ordered a six-month manufacturing suspension for Pharma Research Bio, as the products the company sold in the local market were found to be export-only pharmaceuticals.
The Ministry of Food and Drug Safety ordered Hugel and Pharma Research Bio to recall and destroy all the products in circulation.
However, Hugel, Korea's largest botulinum toxin maker, on Friday refuted the claim and said it will file a suit against the Ministry of Food and Drug Safety to nullify the measures.
“The products were export-only pharmaceuticals, which means we didn’t have to gain approval from the authority when exporting them,” Hugel said in a statement. “We exported the products through a local trading company, and the Ministry of Food and Drug Safety misunderstood the transaction as we sold them in Korea.”
“Hugel’s botulax products are quality-approved items that they have never been in trouble with the law for the past 10 years,” Hugel added. “We will immediately file a suit to invalidate the government’s measure so that it will not have any affects on the company and our products.”
Pharma Research Bio is taking similar action.
The Gangwon-based company said it will take legal action against the government to nullify the decision.

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