USP Helps Expand Worldwide Access to Tuberculosis Drugs

The US Pharmacopeial Convention (USP) and the US Agency for International Development (USAID) through the Promoting the Quality of Medicines (PQM) program has funded Capreomycin, the first “second line” anti-tuberculosis API for injectables. Capreomycin has been assessed by the World Health Organization (WHO) and given prequalification status.

Since 2009, USAID and USP, through the PQM program, have been providing technical and professional assistance to manufacturers and regulatory agencies in countries around the world to strengthen quality assurance systems for medicines, guide manufacturers toward compliance with WHO good manufacturing practices, and help manufacturers prepare product dossiers for submission to the WHO prequalification program.

As a result, the PQM program has helped three drugs achieve prequalification status including: Cycloserine, an anti-tuberculosis medicine; ZinCfant, a zinc product for managing diarrhea in children; and Capreomycin.