Bangladesh-Based Manufacturer Receives WHO Prequalification of Azithromycin to Treat Trachoma

April 26, 2024, Rockville, MD - The World Health Organization (WHO) Prequalification Unit has approved azithromycin 500mg film-coated tablets manufactured by Bangladesh-based Advancing Chemical Industries HealthCare Limited (ACI). Azithromycin is recommended for treatment and mass distribution administration to control blinding trachoma, a condition that is considered a neglected tropical disease (NTD). This approval marks the first prequalification (PQ) of azithromycin 500mg tablet under the NTD therapeutic area.

The Promoting the Quality of Medicines Plus (PQM+) program, funded by the United States Agency for International Development (USAID) and implemented by U.S. Pharmacopeia (USP), supported ACI in attaining WHO PQ status. The prequalification indicates that this medicine meets acceptable standards of quality, safety, and efficacy, signaling confidence in azithromycin 500mg tablets manufactured by ACI to be sourced and distributed for treatment by United Nations agencies and other medicines procurement entities.

NTDs affect more than 1 billion people (nearly one-eighth of the world's population). According to WHO, trachoma, caused by Chlamydia trachomatis, is present in 42 countries across Africa, Latin America, Asia, Australia, and the Middle East and primarily occurs in rural and low-income communities. Trachoma is responsible for the blindness or visual impairment of about 1.9 million people and causes about 1.4 percent of all blindness worldwide. The disease results in up to USD $8 billion in lost productivity each year and disproportionately impacts women, who are up to four times more likely to suffer blindness due to trachoma.

"We wish to express our profound appreciation to USAID and USP for the unreserved technical assistance, collaboration, and cooperation provided by the PQM+ program that resulted in the successful prequalification of our product, azithromycin 500mg film-coated tablet, which is our first product to get an approval by WHO prequalification," Dr. ABM Mahfuz ul Alam, Director of Quality Operations at ACI, said.

PQM+ supported ACI in assessing and improving onsite good manufacturing practices and provided training and technical assistance on product development, dossier preparation, technical document review, and best practices for WHO PQ submission. PQM+ identified ACI through an expression of interest issued in December 2021 for technical support toward WHO prequalification.

"This achievement exemplifies the solid commitment by PQM+ to strengthen regional production of lifesaving medicines and marks an important step in the advancement of Bangladesh's pharmaceutical manufacturing capacity," PQM+ Director and USP Vice President Jude Nwokike said. "As we celebrate this milestone, we renew our commitment to eliminating trachoma and improving the lives of vulnerable populations worldwide through ensuring access to quality-assured essential medical products." PQM+ currently support 32 manufacturers in 11 countries to pursue WHO prequalification or other regulatory approvals.

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About PQM+
USAID's PQM+ program works to sustainably strengthen medical product quality assurance systems and helps ensure access to quality-assured essential medicines for HIV/AIDS, tuberculosis, malaria, neglected tropical diseases, COVID-19 and other infectious diseases as well as for maternal, newborn, and child health.

About USP
USP is an independent, international, and scientific nonprofit organization focused on building trust in the supply of safe, quality medical products. We are working to strengthen the global supply chain so the medical products people rely on for health are available when needed and work as expected. USP has 16 offices across 13 countries and implements global health programs in 50+ countries worldwide.

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