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Malaria continues to be a major public health burden in many parts of the world, particularly in sub-Saharan Africa, Southeast Asia, and parts of Latin America. The disease, caused by the Plasmodium parasite, is responsible for hundreds of thousands of deaths annually, with children and pregnant women being the most vulnerable. Over the past two decades, Artemisinin-based combination therapies (ACTs) have become the cornerstone of global malaria treatment strategies, with Artemether and Lumefantrine recognized as the most effective and widely used ACT for uncomplicated Plasmodium falciparum malaria.
BluepillExpress, a WHO-GMP certified third-party pharmaceutical manufacturer, is proud to offer comprehensive manufacturing solutions for Artemether & Lumefantrine. With a strong focus on quality, affordability, and global compliance, we supply high-efficacy anti-malarial medicines to health ministries, humanitarian organizations, and private distributors worldwide.
About BluepillExpress
BluepillExpress is a trusted pharmaceutical manufacturer and global exporter specializing in third-party and contract manufacturing services for essential medicines. Our facilities are ISO 9001:2015 and WHO-GMP certified, and we offer end-to-end production solutions for pharmaceutical companies, non-governmental organizations, and government health departments.
We have a consistent presence in over 30 countries, including regions with high malaria burden, and are a preferred supplier in many national procurement programs.
Core Strengths:
- WHO-GMP certified manufacturing facilities
- Expertise in fixed-dose combination drugs and public health products
- Customizable packaging and branding options
- Regulatory dossier and documentation support for international markets
- High-capacity production and export logistics management
Product Description: Artemether & Lumefantrine
Artemether is a potent antimalarial derived from artemisinin, and Lumefantrine is a longer-acting antimalarial from the aryl amino alcohol class. The fixed-dose combination ensures rapid parasite clearance and prevents resistance by utilizing dual mechanisms of action.
Mechanism of Action:
- Artemether rapidly reduces the parasite load by generating free radicals that damage parasitic proteins.
- Lumefantrine inhibits heme polymerization, prolonging the antimalarial effect and preventing reinfection.
Therapeutic Class: Artemisinin-Based Combination Therapy (ACT)
Indication: Treatment of uncomplicated Plasmodium falciparum malaria
Available Dosage Forms and Strengths
BluepillExpress manufactures Artemether & Lumefantrine in multiple dosage strengths to meet regional dosing protocols:
- Artemether 20 mg + Lumefantrine 120 mg Tablets – Standard adult and pediatric dose
- Artemether 40 mg + Lumefantrine 240 mg Tablets – For adult and higher-weight patients
- Dispersible tablets for pediatric use – available upon request
All products are developed as film-coated tablets to improve stability and patient compliance.
Packaging Options
To suit the needs of varying healthcare systems and environments, we provide flexible and export-compliant packaging:
- 1×6 tablets – Standard 3-day course for malaria treatment
- 1×12 tablets – Extended regimen or institutional supply
- 1×24 tablets – Bulk supply for high-risk zones or mass treatment programs
- Alu-Alu blister or Alu-PVC blister packs
- HDPE bottles for hospital or government supply
- Custom cartons with multilingual inserts
Each pack is carefully designed to maintain product stability in humid and tropical climates.
Target Patients
- Adults and children (5 kg and above)
- Patients diagnosed with uncomplicated P. falciparum malaria
- Individuals residing or traveling in malaria-endemic regions
- Eligible use in pregnant women in second and third trimesters (under medical supervision)
Advantages of Artemether & Lumefantrine
- High efficacy and rapid symptom relief within 48 to 72 hours
- WHO-recommended first-line treatment
- Combination mechanism prevents resistance development
- Safe profile for pediatric, adult, and pregnant patients
- Once or twice-daily dosing improves patient adherence
- Well-tolerated with minimal gastrointestinal or neurological side effects
Manufacturing Capabilities at BluepillExpress
BluepillExpress operates state-of-the-art manufacturing units equipped with:
- Automated tablet compression and coating lines
- Dedicated blending and granulation zones
- Air-handling systems with HEPA filters to maintain cleanroom standards
- Validated cleaning protocols to prevent cross-contamination
- Robust quality systems for in-process and final product checks
We are capable of fulfilling both bulk and customized batch orders, suitable for tenders, hospital supply chains, and emergency stockpiling.
Quality Assurance & Quality Control
All Artemether & Lumefantrine products at BluepillExpress are manufactured under stringent quality protocols:
- Raw material testing (identity, purity, assay, residual solvents)
- In-process checks (hardness, friability, disintegration, weight variation)
- Finished product testing (dissolution, assay, uniformity of content, microbial limits)
- Stability testing under ICH guidelines (Zone II and Zone IVb)
- Validated analytical methods including HPLC and UV spectrophotometry
Each batch is accompanied by a Certificate of Analysis (CoA) and Batch Manufacturing Record (BMR) ensuring full traceability and regulatory compliance.
Shelf Life and Storage Conditions
- Shelf life: 24 to 36 months
- Storage Conditions: Store below 30°C in a dry, shaded environment
- Packaging designed to protect against moisture, light, and high temperatures common in malaria-endemic zones
Regulatory and Documentation Support
BluepillExpress provides full regulatory documentation for smooth registration and import clearance:
- Certificate of Pharmaceutical Product (COPP)
- WHO-GMP Certificate
- Free Sale Certificate
- Certificate of Analysis (CoA)
- MSDS and Technical Data Sheet
- Product Information Leaflet and Label Templates
- CTD/ACTD-format dossiers for registration across multiple markets
- Support for tender documentation and WHO prequalification pathways (on request)
We assist clients in drug registration with Ministries of Health in Africa, Southeast Asia, Latin America, and CIS regions.
Private Label & Custom Branding
Our private label services enable partners to launch Artemether & Lumefantrine under their own brand names, with:
- Custom printed packaging and foil
- Company logos and local branding elements
- Multilingual product inserts
- Dosing charts and patient education materials
- Market exclusivity arrangements (negotiable based on volume)
This is ideal for distributors, pharmacies, and humanitarian NGOs managing local malaria initiatives.
Global Export and Logistics Management
BluepillExpress ensures seamless product delivery to over 30+ international destinations with:
- Temperature-controlled logistics (if required)
- Air, sea, and land freight capabilities
- Compliant export documentation including packing list, invoice, bill of lading, and CoA
- Pre-shipment inspection support (SGS, Bureau Veritas, Intertek if needed)
- Multi-product container load options for consolidated procurement
We specialize in serving government tenders, international NGOs, and donor-funded malaria control programs.
Client Profiles and Use Cases
- Public health authorities and national malaria control programs
- Hospitals and healthcare procurement agencies
- Humanitarian NGOs like WHO, MSF, UNICEF, Global Fund recipients
- International distributors of anti-infective medicines
- OTC and prescription brands focused on tropical disease management
Why Choose BluepillExpress for Artemether & Lumefantrine Manufacturing?
- WHO-GMP certified production standards
- High-volume, cost-effective manufacturing
- Regulatory-ready product with dossier support
- Compliant with global and local malaria treatment guidelines
- End-to-end packaging, labeling, and logistics solutions
- Flexible batch sizes and private label capabilities
- Committed to public health and sustainable manufacturing
Conclusion
As the global health community continues its battle against malaria, Artemether & Lumefantrine remain central to treatment strategies. At BluepillExpress, we are proud to contribute to this global mission by providing high-quality, affordable, and accessible antimalarial medicines through our third-party manufacturing services.
With our integrated manufacturing expertise, regulatory compliance, and logistical strength, we are equipped to serve partners worldwide—from government health agencies to humanitarian aid organizations.
