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Malaria continues to be one of the world’s most serious and life-threatening infectious diseases, particularly in sub-Saharan Africa, parts of Asia, and Latin America. The challenge of drug-resistant Plasmodium falciparum strains has led to the development and adoption of combination therapies that offer superior efficacy, reduced resistance potential, and tolerable side effect profiles.
Among the most reliable and well-tolerated fixed-dose combinations for malaria treatment and prophylaxis is Atovaquone + Proguanil, a dual-agent regimen that is widely recommended by the World Health Organization (WHO) for the prevention and treatment of P. falciparum infections, especially in areas with multidrug resistance.
BluepillExpress, a WHO-GMP-certified third-party pharmaceutical manufacturing partner, proudly offers scalable production of Atovaquone + Proguanil tablets for both global export and domestic distribution. Our manufacturing capabilities meet international quality standards, offering flexibility for private labeling, government tenders, humanitarian aid programs, and travel medicine providers.
What is Atovaquone + Proguanil?
Atovaquone + Proguanil is a fixed-dose antimalarial combination developed to treat and prevent malaria caused by Plasmodium falciparum, including chloroquine-resistant strains. The combination acts synergistically, targeting multiple stages of the malaria parasite’s lifecycle and helping to minimize the emergence of resistance.
- Atovaquone is a hydroxynaphthoquinone that inhibits mitochondrial electron transport in malaria parasites, leading to the collapse of mitochondrial membrane potential and parasite death.
- Proguanil is a biguanide that is converted in the body to cycloguanil, an inhibitor of dihydrofolate reductase, thereby interfering with DNA synthesis and parasite replication.
Together, they provide causal and suppressive prophylaxis, acting on the liver stage and blood stage of the malaria lifecycle, which makes them uniquely effective for both treatment and prevention.
Therapeutic Class
- Antimalarial Agent (Combination)
- Mitochondrial Electron Transport Inhibitor + Dihydrofolate Reductase Inhibitor
- Fixed-Dose Combination (FDC)
Key Benefits of Atovaquone + Proguanil
1. Highly Effective Against Drug-Resistant Malaria
Effective against chloroquine-, sulfadoxine-pyrimethamine-, and mefloquine-resistant P. falciparum strains.
2. Dual Mechanism of Action
Targets the liver and blood stages of the parasite life cycle, making it suitable for treatment and prophylaxis.
3. Short Prophylaxis Regimen
Prophylaxis can begin just 1–2 days before travel and continue for 7 days after, offering convenience compared to other regimens that require weeks of follow-up dosing.
4. Excellent Tolerability
Well-tolerated in both adult and pediatric patients, with minimal neuropsychiatric side effects compared to older agents like mefloquine.
5. WHO Recommended
Recognized by WHO, CDC, and major public health authorities as a first-line option for travelers, NGOs, military personnel, and malaria-endemic regions.
Indications
The Atovaquone + Proguanil combination is indicated for:
- Treatment of acute, uncomplicated Plasmodium falciparum malaria, including strains resistant to other antimalarial drugs
- Prophylaxis of P. falciparum malaria, particularly for travelers visiting endemic areas
- Alternative therapy for patients unable to tolerate or resistant to other antimalarial medications
Not intended for severe or complicated malaria (e.g., cerebral malaria), which requires parenteral therapy.
Available Strengths and Formulations
BluepillExpress manufactures Atovaquone + Proguanil in the following internationally accepted strengths:
For Adults:
- Atovaquone 250 mg + Proguanil 100 mg tablets
For Pediatric Use:
- Atovaquone 62.5 mg + Proguanil 25 mg tablets
Each tablet is:
- Film-coated for ease of swallowing and protection from moisture
- Manufactured with USP/BP/EP-grade APIs
- Supplied in blister packs or HDPE bottles as per partner preference
- Subjected to rigorous quality checks for assay, dissolution, and stability
Dosage and Administration
For Treatment of Malaria:
- Adults and children weighing ≥40 kg: 4 adult tablets once daily for 3 consecutive days
- Children weighing 11–40 kg: Weight-based dosing with pediatric tablets once daily for 3 days
- Administer with food or a milky drink to enhance absorption
For Prophylaxis:
- Begin 1–2 days before entering a malaria-endemic area
- Continue daily during stay and for 7 days after leaving the area
- Dosing is weight-based in pediatric patients
Important Notes:
- Missed doses reduce efficacy
- Should not be used in patients with severe renal impairment
- Not suitable for pregnant or breastfeeding women unless advised by a doctor
Manufacturing Capabilities
BluepillExpress is equipped with modern infrastructure and scalable capacity to produce Atovaquone + Proguanil formulations for various therapeutic needs.
Facility Highlights:
- High-speed tablet compression and coating lines
- Automated blending and granulation systems
- Controlled environment for moisture- and light-sensitive APIs
- In-line QC checkpoints for weight, hardness, and disintegration
- WHO-GMP certified production and packaging units
Our facilities are compliant with global standards, making us ideal for clients seeking fast registration, bulk supply, and international distribution.
Packaging and Labeling Options
We provide a variety of packaging solutions to cater to different customer segments:
Primary Packaging:
- Alu-Alu blister packs (10×1, 10×10, 2×3 configurations)
- HDPE bottles with desiccants and child-resistant caps
- Moisture-resistant pouches for NGO or travel medicine kits
Secondary Packaging:
- Mono cartons with multilingual printing
- Custom artwork, logo placement, and branding support
- Serialization, barcoding, and batch traceability features
- Regulatory-compliant leaflet inserts (PILs)
Quality Assurance and Regulatory Compliance
We maintain strict quality control at every stage, from raw material sourcing to finished product release.
Certifications:
- WHO-GMP
- ISO 22000:2018
- FSSAI
- FDA India Manufacturing License
- EU and ROW dossier support (on request)
Quality Control Testing:
- Active ingredient assay and uniformity
- Dissolution and disintegration testing
- Related substances and impurity profiling
- Microbial contamination testing
- Real-time and accelerated stability studies
Each batch is released only after full QA clearance and is accompanied by a Certificate of Analysis (CoA).
Regulatory Documentation Support
We assist clients with complete documentation support for market registration, tenders, and NGO procurement.
Available Documents:
- Certificate of Analysis (CoA)
- Certificate of Pharmaceutical Product (COPP)
- Free Sale Certificate (FSC)
- Certificate of Origin (COO)
- MSDS (Material Safety Data Sheet)
- Product Dossier (CTD/ACTD modules)
- Artwork and Labeling Files
- Real-time Stability Data
We support registration efforts in Africa, Southeast Asia, CIS, Latin America, and the Middle East.
Export and Logistics Services
BluepillExpress offers end-to-end export solutions for our global customers:
- Incoterms: EXW, FOB, CIF, DDP
- Shipping Modes: Air and Sea Freight
- Documentation: Commercial invoice, packing list, CoO, CoA, MSDS
- Logistics Coordination: With customs, forwarders, and warehousing teams
- Temperature-controlled transport available (if needed)
Minimum Order Quantities and Lead Time
| Formulation | MOQ | Lead Time |
|---|---|---|
| Atovaquone + Proguanil Adult Tabs | 100,000 tablets | 20–25 working days |
| Pediatric Formulations | 50,000 tablets | 20–25 working days |
| Custom Label & Branding | 25,000 tablets | 25–30 working days |
| Pilot / Sample Batch | 50–100 packs | 7–10 working days |
Lead times may vary based on packaging complexity, regulatory needs, and artwork finalization.
Market Demand and Opportunity
Atovaquone + Proguanil is a high-demand antimalarial therapy in:
- Traveler’s medicine for individuals visiting endemic areas
- National malaria control programs
- NGO and humanitarian health kits
- Export to endemic countries where resistance is rising
- Military and corporate health units
With growing awareness and the global effort to eliminate malaria, the demand for WHO-recommended, resistance-friendly antimalarials is steadily increasing.
Ideal Business Partners
We collaborate with:
- Generic pharmaceutical exporters
- Travel and preventive medicine companies
- Government and NGO procurement agencies
- Pharmacy chains and online pharmacy brands
- Private-label marketers
- Multinational distributors and tender contractors
Whether you’re launching a new line or expanding your antimalarial portfolio, BluepillExpress delivers tailored solutions to support your growth.
Why Choose BluepillExpress?
- WHO-GMP certified, export-focused manufacturing
- Extensive experience with antimalarial formulations
- Full technical and regulatory documentation
- Flexibility in branding, formulation, and packaging
- Dedicated support team for global partners
- Reliable production and on-time delivery
Conclusion
The combination of Atovaquone + Proguanil remains one of the most effective and trusted solutions for both treatment and prevention of Plasmodium falciparum malaria, particularly in resistant regions. Its ease of use, high efficacy, and safety make it a top choice for healthcare providers, NGOs, travelers, and national health programs alike.
As a trusted third-party manufacturing partner, BluepillExpress is committed to delivering world-class formulations, regulatory excellence, and commercial support to help you bring this vital therapy to the markets and populations that need it most.
