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MediTox headquarters. (Photo = MediTox) |
[Alpha Biz= Kim Jisun] Seoul, September 22, 2025 – The Ministry of Food and Drug Safety (MFDS) has imposed fines totaling KRW 456.05 million on MediTox for manufacturing its botulinum toxin product Meditoxin using unauthorized raw materials.
According to the MFDS, fines of KRW 442.75 million were imposed in lieu of a 3-month and 25-day suspension of manufacturing operations for Meditoxin Injection and Meditoxin Injection 50 units. An additional KRW 13.3 million fine was imposed in lieu of a 2-month and 10-day suspension for Meditoxin Injection 150 units.
Violations included manufacturing and selling pharmaceuticals without updating approved manufacturing methods, releasing products with potency test failures, shipping substandard products, and falsifying test reports. Compared to the 2020 measures—which included product sales suspensions and license cancellations—the latest administrative action represents a reduced penalty.
The MFDS explained that the reduction followed a March 2025 Supreme Court ruling, which upheld lower court decisions favoring MediTox in its legal challenge against prior administrative sanctions.
On March 13, the Supreme Court’s First Division dismissed the MFDS’s appeal in the case concerning license cancellations and suspension orders for three Meditoxin products (50, 100, and 150 units). The ruling followed earlier decisions by the Daejeon District Court in November 2023 and the Daejeon High Court in September 2024, both of which sided with MediTox.
Alphabiz Reporter Kim Jisun(stockmk2020@alphabiz.co.kr)
