YungShin 's Quality Once Again Recognized by the U.S. FDA

Our company’s antibiotic product, Cefaclor Suspension Powder (ANDA # 065412), was launched in the United States at the end of 2012 and is currently the only product of its kind available on the market. In January of this year, it was approved by the U.S. Food and Drug Administration (FDA) and officially included in the FDA's Orange Book under the "Reference Listed Drug (RLD)" list, which can be accessed at http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM385885.pdf

All RLDs listed in the Orange Book are FDA-approved standard drugs. Pharmaceutical companies applying for ANDA approval must conduct in vitro dissolution tests and in vivo bioequivalence studies to demonstrate the same release rate and bioabsorption as the RLD.

Cefaclor Suspension Powder is one of the few FDA-approved antibiotic medications for children. Currently, this product is co-marketed by YungShin and the U.S. pharmaceutical company, Pack Pharmaceutical. Since its launch, it has generated tens of millions in profits for YungShin. The inclusion of this standard drug once again demonstrates that YungShin’s quality is on par with international pharmaceutical giants.