Yungshin’s Cefaclor (Oral Suspension) Has Been Certified by FDA of the U.S. as a Standard Drug

Yungshin’s Cefaclor (Oral Suspension) (ANDA # 065412) was marketed in the U.S. at the end of 2012 as the only dosage of the component. In this January, Cefaclor (Oral Suspension) was approved by FDA of the U.S. and included in the Reference Listed Drug (RLD) of the Orange Boo

The RLD of the Orange Book includes standard drugs certified by FDA. Drug manufacturers that apply for ANDA have to compare the in vitro dissolution test and in vivo bioequivalence test with the RLD to demonstrate the same release rate and in vivo absorption effect.

As one of the few FDA certified antibiotics for children, Cefaclor (Oral Suspension) is currently marketed by Yungshin in cooperation with Pack Pharmaceutical, an American drug manufacturer and has brought tens of millions of profits to Yungshin as of today. The certification of this standard drug once again proves that Yungshin is able to compete with international major drug manufacturers in terms of quality.