South Korea’s Daewoong Pharmaceutical said Tuesday that its newly-constructed botulinum toxin production plant in Hwaseong, Gyeonggi Province, has received local regulatory clearance.

The Korean Ministry of Food and Drug Safety has granted Good Manufacturing Practice approval to Daewoong’s new plant designed to manufacture Nabota, the drugmaker’s botulinum toxin.

With the addition, Daewoong now possesses two plants able to collectively produce 5 million vials of the wrinkle-fighting drug. If needed, Daewoong has the option to add new production lines to raise its net capacity to 9 million vials per year, guaranteeing a stable supply. 

Daewoong had expanded its production facilities as it prepares to begin selling Nabota in the US market. Daewoong and its US marketing partner Alphaeon submitted Nabota to the US Food and Drug Administration in May. Nabota was submitted to the European Medicines Agency in June as well.

Meanwhile, Daewoong is also mired in an ongoing legal dispute with Korea’s largest botulinum toxin maker, Medytox, in the US and Korea over alleged intellectual property theft. Medytox claims Daewoong stole its BTX bacterial strain and manufacturing know-how in developing Nabota.

By Sohn Ji-young (jys@heraldcorp.com)