Daewoong’s BTX Secures Approval In Argentina

Daewoong Pharmaceutical announced that its botulinum toxin (BTX) product, Nabota, has received approval from Argentina’s ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología). This makes Nabota the first and only Korean botulinum toxin to be approved in Argentina. The product will be marketed under the name Clodew in dosages of 100 units and 200 units.

Daewoong said in a statement, “Argentina is known for its high entry barriers for Korean pharmaceutical companies. While it is easier to obtain drug approvals in Argentina if a country is classified as a high sanitary surveillance nation, Korea is not on this list. As a result, companies must hold GMP certifications from high sanitary surveillance countries like the U.S. or Europe to enter the Argentine market, making it nearly impossible to do so without such credentials.”

Argentina offers a promising market for pharmaceuticals, ranking among the top three healthcare markets in Latin America. The country shows a strong public interest in cosmetic and aesthetic treatments. Data from the International Society of Aesthetic Plastic Surgery (ISAPS) indicates that last year, Argentina had 4.5 BTX procedures per 1,000 people, placing it fourth globally in per capita botulinum toxin usage. Daewoong Pharmaceutical plans to introduce Clodew in Argentina in the fourth quarter of this year, partnering with Oxapharma S.A., a company known for its expertise in pharmaceuticals, cosmetics, and aesthetics. Oxapharma's extensive portfolio, which includes hyaluronic acid fillers and skin boosters, is expected to create a synergistic effect with Clodew.

Park Sung-soo, CEO of Daewong Pharmaceuticals said, "Argentina is a highly influential and continuously growing market in the beauty and medical industry, but it poses significant challenges for Korean companies. Using Clodew's approval, we aim to expand Daewoong's presence in the Latin American BTX market.”