In the pharmaceutical industry, Primaquine Phosphate is a specialized 8-aminoquinoline and the only widely available drug capable of achieving a “radical cure” for malaria. As a pharmacist and manufacturer, I view this molecule as a critical public health tool, specifically designed to target the dormant liver stages of the parasite that other drugs cannot reach.
At your WHO-GMP facility in Mumbai, Primaquine (available in 7.5 mg and 15 mg tablets) is a high-impact SKU for export to malaria-endemic regions in Africa and Southeast Asia.
The Dosing Protocol: “Radical Cure” Strategy
Primaquine is almost never used alone; it is typically taken after or alongside a blood-stage antimalarial (like Chloroquine or an ACT).
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For P. vivax & P. ovale (Radical Cure): The standard adult dose is 15 mg once daily for 14 days. This is essential to prevent the “relapse” of malaria months or years later.
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For P. falciparum (Gametocytocidal): A single “low dose” (often 0.25 mg/kg or a flat 15 mg or 45 mg dose) is given as a one-time treatment to stop the transmission of malaria to mosquitoes.
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Administration: It must be taken with food (a full meal) to significantly reduce the risk of gastrointestinal upset.
Mechanism: Targeting the Hypnozoites
Primaquine works where other antimalarials fail: the human liver.
Tissue Schizonticide: It penetrates liver cells to destroy hypnozoites—the dormant “sleeper” cells of P. vivax and P. ovale.
Gametocytocidal Action: It kills the sexual forms of the parasite (gametocytes) in the blood, preventing the person from passing the infection back to a mosquito.
Mitochondrial Disruption: It interferes with the parasite’s DNA and disrupts its mitochondrial electron transport, effectively “starving” the parasite of energy.
The Pharmacist’s “Critical Warning”
As you promote your firm on digital platforms, this is the most vital technical safety point:
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The G6PD Crisis: Primaquine can cause life-threatening Hemolytic Anemia in individuals with a G6PD (Glucose-6-Phosphate Dehydrogenase) deficiency.
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Mandatory Testing: Patients must be tested for G6PD deficiency before starting a 14-day course. If deficient, an alternative weekly dosing schedule (45 mg once weekly for 8 weeks) is sometimes used under strict supervision.
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Pregnancy Contraindication: It is strictly contraindicated during pregnancy because the G6PD status of the fetus cannot be determined, and it can cause fetal hemolysis.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai:
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The “Radical Cure” USP: On your marketplace, highlight Primaquine as the essential companion to Chloroquine. Many buyers look for these as a “Relapse Prevention Kit”.
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Stability for Export: Primaquine is stable but light-sensitive. Utilizing Alu-Alu blister packaging ensures a 36-month shelf life, vital for distribution to remote, tropical regions in Zone IVb.
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Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international health tenders (e.g., Global Fund or USAID) for national malaria elimination programs.