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Daewoong Pharmaceutical's Nabota, a botulinum toxin product, is set to become the first Korean botulinum toxin to enter the Argentine market

Business / Kim Jisun / 07/16/2024 03:33 AM

Photo = Daewoong Pharmaceutical

 

[Alpha Biz= Reporter Kim Jisun] Daewoong Pharmaceutical (069620) is set to launch its botulinum toxin product, Nabota, in Argentina, marking the first time a domestically produced botulinum toxin from Korea enters one of the top three markets in Latin America. The company plans to release the product in the fourth quarter of this year through its local distribution partner, Oxapharma.

On the 15th, Daewoong Pharmaceutical announced that it has received marketing authorization for Nabota from the Argentine National Administration of Drugs, Foods, and Medical Technology (ANMAT). Nabota, initially launched in Korea in 2014, received approval from the U.S. Food and Drug Administration (FDA) in 2019. The product has since been approved in 67 countries across South America, Europe, Asia, and Oceania, with ongoing or impending launches in these regions. This year, it was introduced in Spain under the name NUCEIVA®.

In Argentina, Nabota will be marketed under the name CLODEW, available in 100-unit and 200-unit dosages. Oxapharma plans to leverage its local expertise to lead academic events and marketing initiatives. According to the International Society of Aesthetic Plastic Surgery (ISAPS), Argentina has the fourth highest number of botulinum toxin procedures globally, with 4.5 procedures per 1,000 people.

Despite being one of the top three markets in Latin America, Argentina is known for its stringent regulations, only allowing the import of pharmaceuticals certified by high sanitary surveillance countries. While Korea does not hold this certification, Nabota's approval relied on the GMP (Good Manufacturing Practice) certification of production facilities in the U.S. and Europe, both recognized as high sanitary surveillance regions.

 

 

 

AlphaBIZ Kim Jisun(stockmk2020@alphabiz.co.kr)

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