NAFDAC is a this circular emphasised that it has stopped the registration of Multi-Dose Artemether/Lumefantrine Dry Powder for Oral Suspension
This is the alert from the regulatory agency
Public Alert No. 09/2026.
Public Reminder of NAFDAC’s Regulatory Directive on the Discontinued Registration of Multi-Dose Artemether/Lumefantrine Dry Powder for Oral Suspension
#NAFDACAlerts
NAFDAC is reminding the public of the Regulatory Directive issued last year on the discontinued registration of Multi-Dose Anti-Malarial (Artemether/Lumefantrine) dry powder for Oral Suspension due to the instability of the reconstituted formulations, which results in the loss of efficacy of the suspension.
See Public Alert No. 01/2025 published on the NAFDAC website on the 27th of February 2025 >> bit.ly/4h4ylsi
This Regulatory Directive applies to all locally manufactured and imported Multi-Dose Artemether/Lumefantrine dry powder for oral use.
NAFDAC no longer accepts New, Renewal, and Variation applications for all local and imported Multi-Dose Artemether/Lumefantrine dry powder for oral suspension. The manufacturers will need to produce either dispersible tablets or powder/granule packed in sachets for single doses.
Risk Statement
Stability studies have demonstrated that reconstituted anti-malarial suspensions are unstable, resulting in a loss of efficacy. When a medication loses its efficacy, it becomes less effective, which can have serious health consequences. This may lead to a worsening of the treated condition, an increased risk of complications, delays in treatment, and, in severe cases, could even result in death.
Product details
Product Brand Name: All brands of Multi-Dose Artemether/Lumefantrine dry powder for oral suspension.
Product Manufacturer: All manufacturers and Importers of Multi-Dose Anti-Malarial (Artemether/Lumefantrine dry powder Oral Suspension.
Healthcare professionals and consumers are advised to report any suspicion of sale of these products, substandard and falsified medicines, or medical devices to the nearest NAFDAC office, call 0800-162-3322, or send an email to sf.alert@nafdac.gov.ng