Daewoong Pharmaceutical 'Nabota' Gets Product License in Argentina...K-Toxin for the first time

Jul 16, 2024

Daewoong Pharmaceutical 'Nabota' Gets Product License in Argentina...K-Toxin for the first time



Daewoong Pharmaceutical's botulinum toxin 'Nabota' has obtained product approval from the Argentine Food and Drug Administration (ANMAT). The export name is 'CLODEW' and the permitted capacity is 100 units and 200 units. It is the first and only domestic botulinum toxin preparation that exceeds Argentina's high regulatory hurdles and has been approved for product.

Argentina is a market with very high entry barriers for Korean pharmaceutical companies. If Argentina is classified as a government-recognized high-level biometrics country, it is relatively easy to obtain drug product approval, but Korea is not on the list of high-level biometrics countries in Argentina. In addition, GMP certification for production plants in high-ranking surveillance countries such as the United States and Europe is essential unless they are high-ranking surveillance countries. Analysts say that it was possible because it was GMP-certified by both the US FDA and the European EMA, the most prestigious in the global market, and produced and sold high-quality botulinum toxin to the global market.

Argentina is also an attractive pharmaceutical market. Argentina is one of the three major healthcare markets in Latin America and has a high public interest in plastic surgery and beauty. According to the International Society of Aesthetic Plastic Surgeons (ISAPS), the number of botulinum toxin procedures in Argentina last year was 4.5 per 1,000 people, ranking fourth in the world on average per person.



Daewoong Pharmaceutical will release Clodew in Argentina through its partner Oxapharma S.A. in the fourth quarter of this year. Oxy Pharma, which is responsible for local distribution and sales, is a pharmaceutical, cosmetic, and aesthetic company with a diverse aesthetic portfolio such as hyaluronic acid fillers and skin boosters, so synergy with Clodu is expected. In addition, Oxy Pharma plans to successfully market its brand by leading its own academic events and marketing based on local know-how.

Park Sung-soo, CEO of Daewoong Pharmaceutical, said, "Argentina is an attractive market with great influence in the beauty and medical industries, but it is a very difficult market for Korean companies. We will further expand Daewoong Pharmaceutical's dominance in the toxin market in Latin America based on Clodu's approval of Argentine products." he said.





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