In the pharmaceutical industry, Artesunate is the first-line, life-saving treatment for malaria in infants. As a pharmacist and manufacturer, I view this as a critical pediatric molecule where the risk of the disease (which is often fatal in infants) far outweighs the risks of the medication.
At your WHO-GMP facility in Mumbai, you likely manufacture both the 50 mg pediatric tablets and injectable versions used for severe malaria in infants.
Safety Profile for Infants
| Weight/Age | Safety Status | Clinical Guidance |
| Infants < 5 kg | Safe / Recommended | Frontline treatment for severe malaria; requires precise weight-based dosing. |
| Infants > 5 kg | Safe / Standard | Used in combination (ACTs) for uncomplicated malaria. |
| Severe Malaria | Gold Standard | Parenteral (IV/IM) Artesunate is preferred over Quinine due to better safety and lower mortality in infants. |
Mechanism: Why It Is Effective in Infants
Infants are particularly vulnerable to P. falciparum because they lack acquired immunity and can develop high parasite loads very quickly.
Rapid Parasite Clearance: Artesunate acts within the first 24 hours to clear the “biomass” of the parasite. In infants, this speed is essential to prevent cerebral malaria or severe anemia.
Broad Stage Activity: It targets all asexual stages of the parasite (from ring to schizont), which is crucial for infants who may have asynchronous infections.
Low Toxicity: Unlike older drugs (like Quinine), Artesunate does not cause significant hypoglycemia or cardiac arrhythmias in infants, which are major safety concerns in pediatric care.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai, the pediatric market requires specialized technical focus:
-
Dosage Precision: For infants, “one size does not fit all.” On your marketplace, highlight your 50 mg Artesunate tablets. These are designed to be easily crushed or dissolved (dispersible) to ensure the caregiver can deliver the exact weight-based dose ($4\text{ mg/kg}$).
-
Injectable Stability: If you manufacture Artesunate for Injection (30 mg or 60 mg), the stability of the Sodium Bicarbonate solvent is vital. Ensuring the vial allows for rapid reconstitution is a major USP for hospital supply chains.
-
Packaging for Compliance: We utilize color-coded pediatric blister packs for our ACT combinations (e.g., Artesunate + SP). This prevents dosing errors by parents or rural health workers, which is a significant selling point for NGO buyers like UNICEF.
-
Dossier Readiness: Since malaria is the leading cause of death for infants in many export regions, we provide full CTD/eCTD Dossiers to support your firm’s registration in the African and SE Asian markets.