Quality Testing of Difficult-to-Make Prescription Pharmaceutical Products Marketed in the US

Abstract

Key Points Question Are there substantive differences in the major quality attributes of difficult-to-make pharmaceutical products manufactured throughout the world and marketed in the US? Findings In this quality improvement study, all of 252 drug product samples met the US market standards for the major quality attributes of dosage unit uniformity and dissolution, although there was evidence of differences in the consistency of these attributes among regions and manufacturers. Meaning These findings suggest that difficult-to-make prescription pharmaceuticals marketed in the US consistently meet quality standards even when manufactured outside the US.