Hugel's toxin has been approved for national lot release

Botulax 50 or 200 units on the 15th, Botulax 100 units are approved for lot release on the 16th

The cumulative number of lot release approved this year is the largest among domestic botulinum toxin companies

Status of approval for national lot release of Hugel toxin drugs published in the MFDS.

As Hugel recently obtained approval from the Ministry of Food and Drug Safety for three types of botulinum toxin products, administrative measures such as "cancellation of permission" and "suspension of product sales" on the 10th proved once again that there was a difference in legal interpretation of indirect exports, not quality and safety issues.

 

According to the status of national lot release approval for botulinum toxin posted on the website of the MFDS, Hugel received approval for 50 units of botulinum toxin formulation Botulax and 200 units of Botulax on the 15th.

 

A day later, on the 16th, domestic sales of three Botulax products resumed as additional approval for 100 units of Botulax was obtained.

 

Including the number of national lot releases, Hugel has obtained 156 cumulative approvals this year.

 

It is the largest number of botulinum toxin companies in Korea.

 

Competitors Daewoong Pharmaceutical, Medy Tox, and Huons have obtained national lot release approval for 84, 80, and 44 cases, respectively.

 

Earlier on the 10th, the MFDS announced that it would start administrative disposition, collection, and disposal procedures for the company's products against Hugel for violating the national lot release.

 

Hugel immediately announced its position and applied for cancellation and suspension of execution, including an order to suspend manufacturing and sales, to the Seoul Administrative Court on the same day.

 

On the morning of the 11th, the next day, it submitted a provisional application for suspension of execution of the Ministry of Food and Drug Safety's disposition, and the court cited it, enabling the sale of four types of Botulax in Korea.

 

An official from Hugel said, "This disposition by the MFDS is only a problem caused by differences in legal interpretation of indirect exports to the Pharmaceutical Affairs Act, and has nothing to do with the product quality of Botulax manufactured and produced by Hugel." He said, "Hugel has received the national lot release without any problems in terms of quality such as effectiveness and safety in compliance with the Pharmaceutical Affairs Act." Biological agents such as botulinum toxin must be approved for lot release to be sold in Korea.