Daewoong Pharmaceutical Tightens Distribution Control After Unauthorized Export of Domestic Nabota Detected

Identifying Supplying Medical Institutions through Lot Number Tracking
Internal Monitoring Uncovers Cases of FDA Import Refusal
"Limits to Company-led Investigations...Government Support Needed"

Daewoong Pharmaceutical is significantly strengthening its genuine product distribution management system to block the illegal distribution of its botulinum toxin product 'Nabota' and protect patient safety.

On July 23, Daewoong Pharmaceutical announced that on July 10, it had received a report from an overseas partner and confirmed that two vials of the domestically supplied Nabota had been shipped out of the authorized distribution channel. The company traced the product’s lot numbers to identify the supplying medical institution and immediately halted transactions with it.

Daewoong Pharmaceutical Botulinum Toxin 'Nabota'. Daewoong Pharmaceutical

During its recent internal monitoring process, Daewoong Pharmaceutical also discovered a case where the U.S. Food and Drug Administration (FDA) refused the importation of Nabota products. The company believes that the product had entered the U.S. through unauthorized channels, rather than through official export routes.

Daewoong Pharmaceutical stated, “There have been no cases of import rejection for products officially exported in compliance with FDA regulations. However, if products enter the U.S. via unauthorized channels, reasons for import refusal such as missing English-language labels or lack of NDA (New Drug Application) approval can be identified.”

The company plans to further strengthen the official distribution management network. Earlier this year, it reported seven domestic companies that received FDA warning letters related to the illegal distribution of botulinum toxin to the Korea Pharmaceutical Distribution Association, the e-People government portal, and the Anti-Corruption and Civil Rights Commission.

However, the company explained that there are limitations to verifying illegal distribution internally. In order to prompt investigations by relevant authorities, specific evidence is required, such as the legal name of the company involved in illegal distribution, the exact timing of the transactions, and detailed records of domestic customs clearance and shipping from Korea.

Park Sungsoo, CEO of Daewoong Pharmaceutical, stated, "As cumulative sales of Nabota have surpassed 1 trillion won, and its presence in the global market has grown, attempts at illegal distribution have also increased. We ask for the attention and active support of the government authorities to ensure patient safety."

This content was produced with the assistance of AI translation services.