Daewoong Pharmaceutical has strengthened its management system for the legal distribution of its botulinum toxin product, Nabota, to prevent illegal distribution and enhance patient safety. The company is implementing AI-based monitoring and a system that permanently halts transactions upon detection of illegal distribution, while also urging government support.
On July 23, Daewoong Pharmaceutical announced that it operates a comprehensive management network for the legal distribution of its products, both online and offline. Since January, the company has introduced a system that immediately suspends transactions upon detection of illegal distribution. It has distributed notices to domestic hospitals and clinics and completed revisions to contracts aimed at preventing illegal distribution, while also collaborating with overseas regulatory agencies to block illegal sales.
The company stated that it is responding strictly to unauthorized export cases. On July 10, it confirmed through a report from a local partner that two vials of Nabota intended for domestic use had been illegally exported. After tracing the manufacturing number, the company identified the medical institution involved and immediately suspended transactions.
Additionally, Daewoong Pharmaceutical reported that it recently identified cases of import rejections by the U.S. Food and Drug Administration (FDA) during its internal monitoring process. The company explained that the products were brought into the U.S. through illegal distribution channels that had not received FDA approval, emphasizing that officially exported products comply with FDA regulations and have no history of import rejections. Products imported through abnormal channels may be rejected for reasons such as 'lack of English labeling' or 'unapproved New Drug Application (NDA).'
Daewoong Pharmaceutical stressed that proper management of legal distribution is directly linked to patient safety, as botulinum toxin must be stored according to the World Health Organization's (WHO) recommended temperature range of 2-8°C.
To ensure this, the company applies a cold chain system throughout the entire process from production to administration. It utilizes passive containers that maintain optimal temperatures for up to 168 hours and active containers equipped with self-cooling devices, while real-time temperature monitoring allows for immediate distribution halts in case of anomalies.
Daewoong Pharmaceutical noted that efforts at the corporate level alone are insufficient to eradicate illegal distribution, emphasizing the need for cooperation from the government and related agencies. Earlier this year, the company reported seven domestic firms that received warning letters from the FDA regarding illegal distribution of botulinum toxin to the Korea Pharmaceutical Distribution Association, the National Petition Center, and the Anti-Corruption and Civil Rights Commission.
Meanwhile, Daewoong Pharmaceutical announced that as of June 30, the cumulative sales of Nabota have surpassed 1 trillion won, marking a significant milestone since its domestic launch 12 years ago in 2014.
Park Sung-soo, CEO of Daewoong Pharmaceutical, stated, "As Nabota's cumulative sales have exceeded 1 trillion won, its presence in the global market has increased, leading to a rise in attempts at illegal distribution. We are operating a robust distribution control network, including AI monitoring, and we request the attention and active support of government authorities to ensure patient safety."
* This article has been translated by AI.
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