In the pharmaceutical industry, Primaquine Phosphate 7.5 mg is a critical 8-aminoquinoline antimalarial. As a pharmacist and manufacturer, I classify this as the “radical cure” agent. While other drugs kill the parasites in the blood, Primaquine is unique because it targets the parasites “hiding” in the liver.

Primary Clinical Uses

• Radical Cure of P. vivax and P. ovale: This is its primary indication. It is used to eliminate the hypnozoites (dormant stages) of malaria in the liver, preventing the patient from suffering a relapse months or years later.

• Gameticidal Action (P. falciparum): It is used as a single dose to kill the gametocytes (the sexual stage) of the parasite in the blood. This prevents the transmission of malaria from an infected human back to a mosquito, acting as a public health tool to stop the spread.

• Pneumocystis Jirovecii Pneumonia (PCP): Occasionally used as an alternative second-line treatment (combined with Clindamycin) for PCP in immunocompromised patients.

Mechanism of Action: Oxidative Stress

Primaquine works by disrupting the metabolic processes of the parasite within the liver cells.

Mitochondrial Interference: It interferes with the parasite’s electron transport chain and mitochondrial function.

Oxidative Damage: The drug is metabolized into highly reactive intermediates that induce oxidative stress.

DNA Disruption: These reactive oxygen species damage the parasite’s DNA and protein synthesis, effectively “flushing out” the dormant liver stages that other antimalarials cannot reach.

The Manufacturer’s Perspective: Technical & Safety

From a production and global trade standpoint at your WHO-GMP facility in Mumbai, Primaquine 7.5 mg requires strict technical oversight:

• The G6PD Constraint (Critical Safety): As a pharmacist, you know that Primaquine can cause acute hemolytic anemia in patients with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency. For your B2B export clients, ensuring that your Product Information Leaflet (PIL) emphasizes G6PD testing before administration is a mark of a high-quality, responsible manufacturer.

• Dosing Variations: We manufacture the 7.5 mg and 15 mg strengths. The 7.5 mg tablet is particularly useful for precise weight-based dosing in pediatric cases or for the 14-day radical cure regimen.

• Stability & Packaging: Primaquine is sensitive to light and moisture. At our Mumbai facility, we utilize Alu-Alu or Amber-colored PVC/PVDC blisters to ensure a 36-month shelf life, which is vital for government tenders and export to Zone IVb regions.

• Dossier Support: This is a cornerstone of the WHO Global Malaria Program. We provide full CTD/eCTD Dossiers to support international registration and supply.