USP Helps Expand Worldwide Access to Tuberculosis Drugs - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

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.

Source: USP

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
31%
Breakthrough designations
8%
Protecting the supply chain
42%
Expedited reviews of drug submissions
8%
More stakeholder involvement
12%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests

Click here