Artemether & Lumefantrine

Malaria remains a major global health threat, particularly in tropical and subtropical regions where Plasmodium falciparum transmission is most prevalent. Among the most effective treatments available is the Artemether and Lumefantrine combination therapy, widely recognized and endorsed by the World Health Organization (WHO) as the first-line treatment for uncomplicated P. falciparum malaria. With growing resistance to older antimalarial drugs, Artemether & Lumefantrine have become essential components of national malaria control programs and international aid interventions.

At BluepillExpress, we offer third-party manufacturing solutions for Artemether & Lumefantrine, providing global partners with access to WHO-GMP compliant, affordable, and export-quality antimalarial formulations. Our proven manufacturing systems, regulatory support, and scalable production make us an ideal partner for healthcare procurement agencies, NGOs, and pharmaceutical companies involved in malaria control.

About BluepillExpress

BluepillExpress is a leading Indian pharmaceutical manufacturing and export company that offers complete third-party and contract manufacturing services across multiple therapeutic categories. We are particularly specialized in anti-infectives, antimalarials, antivirals, and public health essentials.

Key Strengths:

• WHO-GMP and ISO 9001:2015 certified production facilities
• CTD/ACTD dossier and product registration support
• Custom private labeling and packaging design
• High-volume production capabilities suitable for tender and institutional supply
• Export operations in over 30 countries, including Africa, Asia, CIS, and Latin America

We manufacture Artemether & Lumefantrine combinations that meet stringent global quality standards and support national and international anti-malaria strategies.

Product Overview: Artemether & Lumefantrine

Artemether & Lumefantrine is a fixed-dose artemisinin-based combination therapy (ACT) used for the treatment of uncomplicated malaria caused by Plasmodium falciparum. The dual-action mechanism enhances parasite clearance and reduces the risk of resistance development.

Pharmacological Class:

• Artemether: Fast-acting artemisinin derivative
• Lumefantrine: Long-acting aryl amino alcohol

Mechanism of Action:

• Artemether rapidly reduces the parasite biomass by producing free radicals that damage parasite proteins.
• Lumefantrine sustains suppression by interfering with the heme detoxification process in the parasite, ensuring eradication of remaining parasites.

Formulations Available at BluepillExpress

Tablet Dosage Forms:

• Artemether 20 mg + Lumefantrine 120 mg Tablets
• Artemether 40 mg + Lumefantrine 240 mg Tablets
• Pediatric dispersible tablets (available on request)
• Combination with antipyretics or zinc (available upon customization)

Packaging Sizes:

• 1 x 6 Tablets (3-day course)
• 1 x 12 Tablets
• 1 x 24 Tablets (for severe cases or regional guideline adaptations)

Custom packaging and dosage strength combinations are available to meet specific national treatment protocols.

Indications and Usage

• Treatment of uncomplicated malaria caused by P. falciparum
• Mixed infections including P. falciparum and other species (per local guidelines)
• Prophylactic use in some settings (off-label, limited)
• Suitable for use in adults and children over 5 kg body weight

Artemether & Lumefantrine are included in the WHO Model List of Essential Medicines and are a core therapy in malaria-endemic regions.

Advantages of Artemether & Lumefantrine Combination

• Rapid onset of action due to Artemether
• Extended protection with Lumefantrine’s long half-life
• Fixed-dose combination simplifies treatment regimen
• Reduces risk of resistance compared to monotherapy
• Highly effective against multi-drug-resistant P. falciparum
• Minimal adverse reactions and safe for pediatric and adult use
• Endorsed by WHO and national malaria control programs

Manufacturing Infrastructure at BluepillExpress

BluepillExpress operates high-capacity, dedicated manufacturing lines for antimalarial and anti-infective drugs.

Key Manufacturing Features:

• High-speed compression machines for tablet production
• Isolated blending, granulation, and coating areas
• Air handling units (AHUs) for particulate control and humidity management
• Cleanroom conditions for sterile and non-sterile production
• Fully automated blister packing and strip sealing machines
• Integration of serialization and barcoding for traceability

All production is performed in line with WHO-GMP guidelines, ensuring consistent product safety and quality.

Packaging & Labeling Solutions

We offer diverse packaging formats tailored for retail, institutional, or government supply:

Tablet Packaging Options:

• Alu-Alu blister packs (high humidity resistance)
• Alu-PVC blister packs
• Strip packs with printed foil
• Bulk HDPE bottles for hospital or NGO programs

Labeling Support:

• Custom private label branding
• Multilingual printed inserts and cartons
• QR code, barcode, and hologram support
• WHO or donor branding (optional for NGOs and aid agencies)

We also design packaging that complies with UNICEF, WHO-PQ, and national essential medicine programs.

Quality Control & Assurance

Every Artemether & Lumefantrine batch is rigorously tested at our in-house analytical labs and monitored by our Quality Assurance (QA) and Quality Control (QC) departments.

Testing Parameters Include:

• Raw material verification (ID, assay, microbial limits)
• In-process checks (blend uniformity, tablet hardness, friability)
• Finished product analysis (disintegration, dissolution, potency, uniformity)
• Stability testing as per ICH guidelines
• Packaging integrity testing

All batches come with:

• Certificate of Analysis (CoA)
• Batch Manufacturing Record (BMR)
• Product Specifications
• Stability reports (accelerated and long-term)

Shelf Life and Storage Conditions

• Typical Shelf Life: 24 to 36 months
• Recommended Storage: Store below 30°C, away from direct sunlight and moisture
• Products packed in moisture-resistant blisters to ensure stability in tropical climates

Regulatory Support & Export Documentation

BluepillExpress provides full regulatory assistance and export documentation to facilitate seamless global distribution.

Provided Documents Include:

• Certificate of Pharmaceutical Product (COPP)
• WHO-GMP Certificate
• Free Sale Certificate
• CTD/ACTD Dossiers (Modules 1–5)
• Product Artwork and Label Mockups
• MSDS and Technical Data Sheets
• Country-specific registration support
• Customs and shipping documentation (Invoice, Packing List, Bill of Lading)

We have successfully registered Artemether & Lumefantrine products in multiple countries through governmental health authorities.

Private Label and Custom Branding Services

Our private label solutions allow our partners to distribute Artemether & Lumefantrine under their own brand names while we manage end-to-end production and regulatory compliance.

Features:

• Custom brand name and logo on tablets and cartons
• Tailored artwork for market preferences
• Brand registration assistance
• Small and large batch size flexibility
• Trademark and confidentiality protection

Ideal for distributors, pharmacy chains, e-pharmacies, and government partners launching localized health campaigns.

Global Logistics and Supply Chain Management

We provide turnkey logistics support for Artemether & Lumefantrine shipments across the globe.

Logistics Capabilities:

• Air and sea freight coordination
• Multi-modal delivery for institutional buyers
• Temperature-controlled packaging on request
• Real-time tracking with global courier partners
• Consolidation for multi-product shipments
• Warehouse-to-door delivery to port, ministry, or NGO partner

We manage logistics for bulk orders, government tenders, and emergency humanitarian shipments.

Target Market and Clients

• Ministries of Health (MoH)
• NGOs and humanitarian aid organizations (e.g., WHO, UNICEF, MSF)
• International donor-funded malaria programs
• Institutional hospital supply networks
• Retail pharmacy chains in malaria-endemic countries
• Government and public sector tender bidders

We serve clients engaged in malaria prevention, treatment, and elimination programs.

Why Choose BluepillExpress for Artemether & Lumefantrine Manufacturing?

• WHO-GMP certified facilities with proven public health drug experience
• High-capacity production with tight quality control
• Custom formulation and packaging based on national guidelines
• Experienced regulatory team for dossier and country-specific support
• Affordable pricing for bulk procurement and tenders
• Full private label and branding capabilities
• Global logistics and documentation support
• Proven track record in supplying to NGOs, hospitals, and ministries

Conclusion

As malaria continues to claim lives in vulnerable populations, Artemether & Lumefantrine stand as essential medicines for effective, rapid, and reliable treatment. At BluepillExpress, we are proud to support global malaria control efforts through our GMP-compliant manufacturing, regulatory expertise, and supply reliability.

Whether you’re a distributor, government health agency, or international health program, BluepillExpress is your trusted partner for high-quality Artemether & Lumefantrine combinations that save lives and improve public health outcomes.