In September 2025, the WHO Prequalification Unit added new dispersible tablet formulations combining amodiaquine and sulfadoxine/pyrimethamine, manufactured by Ajanta Pharma Limited, to its prequalified list. (extranet.who.int) This development enhances the availability of child-friendly antimalarial treatments.
In October 2024, the FDA updated Import Alert 66-66, focusing on APIs that appear to be misbranded due to labeling deficiencies. This underscores the importance of compliance with labeling requirements for exporters targeting the U.S. market.
In February 2026, the FDA issued Import Alert 66-41, concerning the detention without physical examination of unapproved new drugs promoted in the U.S. While not specific to pyrimethamine, this alert highlights the FDA's ongoing efforts to monitor drug imports.
In March 2026, the FDA issued Import Alert 16-120, detaining without physical examination fish and fishery products from foreign processors not in compliance with seafood HACCP regulations. Although unrelated to pyrimethamine, this reflects the FDA's stringent import controls across various sectors.
In March 2026, the FDA issued Import Alert 99-45, detaining without physical examination food products that are or contain an unsafe food additive. This alert emphasizes the FDA's commitment to ensuring the safety of imported food products.
These developments highlight the dynamic regulatory environment affecting pyrimethamine exports and underscore the necessity for exporters to stay informed and compliant with international standards.
