Daewoong Pharmaceutical said its botulinum toxin (BTX) product Nabota received product approval from Argentina’s ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología).

The approved dosages are 100 units and 200 units, and it will be marketed under the name Clodew.

According to the company, it is the first and only Korean botulinum toxin to receive approval in Argentina.

“Argentina is known for its high entry barriers for Korean pharmaceutical companies,” Daewoong said. “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, it added.

Argentina presents an attractive market for pharmaceuticals. It is one of the top three healthcare markets in Latin America, with a high public interest in cosmetic and aesthetic treatments.

According to the International Society of Aesthetic Plastic Surgery (ISAPS), the frequency of BTX procedures in Argentina was 4.5 per 1,000 people last year, ranking the country fourth globally in terms of per capita botulinum toxin usage.

Daewoong Pharmaceutical plans to launch Clodew in Argentina in the fourth quarter of this year through its partner, Oxapharma S.A., which specializes in pharmaceuticals, cosmetics, and aesthetics, has a comprehensive portfolio that includes hyaluronic acid fillers and skin boosters, promising synergy with Clodew.

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