Daewon Pharmaceutical "Col Daewon Kids Pen Syrup", Product Improvement and Production Resumption

Application of Mixing Ratios That Prevent Phase Separation

Daewon Pharmaceutical announced on the 11th that it will resume manufacturing and sales following the Ministry of Food and Drug Safety's lifting of the suspension order on the production and sale of the children's antipyretic analgesic 'Kol Daewon Kids Pen Syrup.'

Jeje Gaeseon Renewed Kol Daewon Kids Pen Syrup.
[Photo by Daewon Pharmaceutical]

To resolve the shortage of children's fever reducers, Daewon Pharmaceutical immediately resumed production of Kol Daewon Kids Pen Syrup on the 10th, right after the Ministry of Food and Drug Safety announced the lifting of the suspension. Starting with the initial supply of 210,000 packs of the improved quality product, the company plans to continuously increase production volume. With the largest domestic liquid formulation production facility located in Jincheon, Chungbuk, the company intends to focus all efforts on production to address the shortage of children's cold medicine.

In May, Daewon Pharmaceutical proactively conducted a voluntary recall of the product as a preventive measure due to phase separation observed in Kol Daewon Kids Pen Syrup. At the end of June, the company reported the completion of the recall to the Ministry of Food and Drug Safety, which then conducted an appropriateness evaluation.

Separately, the company has continued research to identify the cause and improve the formulation. After experiments and tests, they discovered the optimal mixing ratio and method that maintain stability without phase separation. The Ministry of Food and Drug Safety confirmed that formulation improvements were made based on the solutions submitted by Daewon Pharmaceutical and lifted the suspension order on manufacturing and sales.

Meanwhile, according to expert consultations, due to the nature of suspension syrups, some ingredients may settle causing phase separation; however, it is known that consuming the separated product poses low risk. Nevertheless, since the uniformity of the active ingredient dosage may be inconsistent, Daewon Pharmaceutical has been conducting formulation improvement research to ensure product uniformity.

A Daewon Pharmaceutical representative stated, "Through close cooperation with the Ministry of Food and Drug Safety, we achieved formulation improvements and received recognition for the product's safety, allowing us to present an improved product to consumers. As the number of children with colds is increasing significantly, we will concentrate our capabilities on production to help alleviate parents' concerns even a little."