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Artemether & Lumefantrine

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BluepillExpress is a globally recognized pharmaceutical third-party manufacturing company committed to producing superior quality medicines that meet international therapeutic needs. With an unwavering focus on quality, safety, and regulatory compliance, we offer end-to-end manufacturing services for a wide range of pharmaceutical products, including antimalarial combinations. Among our core manufacturing competencies is the production of Artemether and Lumefantrine—a gold-standard therapy for malaria treatment in endemic regions.

Our third-party manufacturing services provide pharmaceutical brands, healthcare companies, NGOs, and public health organizations with the opportunity to launch, distribute, or stock WHO-compliant Artemether & Lumefantrine formulations, customized as per regional regulations and commercial needs. With cutting-edge manufacturing facilities, rigorous quality assurance protocols, and global logistics capabilities, BluepillExpress ensures that every batch of Artemether & Lumefantrine meets the highest industry standards.

About Artemether & Lumefantrine

Artemether and Lumefantrine is a fixed-dose combination (FDC) used in the treatment of acute, uncomplicated Plasmodium falciparum malaria. Artemether, a fast-acting artemisinin derivative, rapidly reduces the parasite biomass, while Lumefantrine, with a longer half-life, eliminates the residual parasites, reducing the risk of recrudescence.

This combination therapy is recommended by the World Health Organization (WHO) as a first-line treatment for falciparum malaria, especially in regions where multidrug resistance is prevalent. Its efficacy, safety, and compliance-friendly dosing make it the preferred antimalarial medication in both pediatric and adult populations.

Product Forms Offered by BluepillExpress

BluepillExpress manufactures Artemether & Lumefantrine in various dosage forms, tailored to meet specific market and patient needs. These include:

  • Artemether 20 mg + Lumefantrine 120 mg Tablets
  • Artemether 40 mg + Lumefantrine 240 mg Tablets
  • Dispersible Tablets for pediatric use
  • Customized pack sizes: blister strips, alu-alu packs, or bottle packaging
  • Co-blister packs with additional supportive medication (on request)

Our offerings comply with international pharmacopeial standards (USP/BP/IP) and are supported by complete technical documentation for both regulatory approval and market entry.

Manufacturing Excellence

BluepillExpress operates state-of-the-art pharmaceutical manufacturing units equipped with advanced machinery and modern infrastructure. Our facilities are certified under WHO-GMP, ISO 9001:2015, and are designed to meet global regulatory expectations, including those of USFDA, MHRA (UK), TGA (Australia), and others.

Key features of our Artemether & Lumefantrine production facilities include:

  • Dedicated zones for manufacturing antimalarial drugs
  • Modern granulation and blending systems for uniformity
  • High-speed tablet compression and film-coating machines
  • Integrated HVAC systems ensuring contamination control
  • In-house analytical and microbiological laboratories

Our production processes are meticulously validated and standardized to deliver consistent quality, batch after batch.

Quality Control and Assurance

At BluepillExpress, quality is not just a process but a philosophy. Every stage of Artemether & Lumefantrine manufacturing is governed by a robust quality assurance system that complies with current Good Manufacturing Practices (cGMP).

Our QA/QC processes include:

  • Verification of active pharmaceutical ingredients (APIs) through identity, assay, and impurity profiling
  • In-process checks for blend uniformity, tablet weight variation, friability, hardness, and disintegration
  • Finished product testing for assay, dissolution, uniformity of content, and microbial limits
  • Stability studies under ICH guidelines (zone II and IVB)

Each batch is accompanied by a comprehensive Certificate of Analysis (CoA) and is released only after passing all quality checks.

Certifications and Regulatory Documentation

BluepillExpress supports its clients with a full suite of regulatory and quality documentation required for product registration and market access in different countries. This includes:

  • WHO-GMP certificate
  • Certificate of Pharmaceutical Product (CoPP)
  • Certificate of Analysis (CoA)
  • Stability data reports
  • Product master formula record and batch manufacturing record
  • Technical data sheets and Material Safety Data Sheets (MSDS)
  • Bioequivalence data and dossiers (on request)

We assist in dossier preparation in CTD, ACTD, or country-specific formats, ensuring hassle-free approvals from health authorities worldwide.

Private Labeling and Customization

BluepillExpress offers private labeling and customized packaging options for Artemether & Lumefantrine, empowering pharmaceutical marketers and healthcare institutions to promote the medication under their own brand name. Our customization capabilities include:

  • Branding support: printing your logo, artwork, and brand information
  • Flexible packaging options: alu-alu, blister packs, bottles, or foil pouches
  • Multilingual labeling and inserts to suit regional markets
  • Pediatric-specific designs and flavors for child compliance
  • Tailor-made marketing and promotional support materials

This flexibility allows clients to differentiate their offerings while relying on BluepillExpress’s trusted manufacturing expertise.

International Market Reach and Export Support

BluepillExpress is a prominent exporter of Artemether & Lumefantrine, supplying pharmaceutical products to over 40 countries across Africa, Southeast Asia, Latin America, and CIS regions. Our extensive export experience and deep understanding of local regulatory environments enable us to provide seamless international shipping and support.

We manage:

  • Export-oriented packaging and labeling
  • Legalization and embassy attestation of documents
  • Handling of Letters of Credit (LCs) and other trade instruments
  • Customs clearance and freight forwarding

Our strong supply chain network ensures prompt delivery and uninterrupted availability of Artemether & Lumefantrine to the most remote or high-demand locations.

Research and Development Capabilities

Our in-house R&D team works tirelessly to innovate and improve our formulations. We collaborate with clients on projects such as:

  • Development of child-friendly dispersible tablets
  • Taste-masking for improved compliance
  • Bioequivalence studies and product improvement
  • Co-formulation with other drugs for public health programs
  • Process optimization for better yield and cost efficiency

This scientific capability allows us to offer a competitive advantage in both mature and emerging pharmaceutical markets.

Client Collaboration Model

BluepillExpress follows a structured and transparent client onboarding and manufacturing process:

  1. Requirement Gathering: Detailed consultation to understand dosage strength, registration needs, and market strategy
  2. Quotation & Proposal: A comprehensive proposal including cost, timelines, packaging, and logistics
  3. Documentation & Agreement: Non-Disclosure Agreement (NDA), product development agreement, and commercial contract
  4. Product Development & Validation: Pilot batch manufacturing, quality testing, and stability studies
  5. Full-Scale Production: Commercial manufacturing as per agreed specifications
  6. Packaging & Dispatch: Labeling, packing, documentation, and global shipment

We assign dedicated project managers to each client, ensuring continuous support and clear communication throughout the manufacturing lifecycle.

Advantages of Partnering with BluepillExpress

BluepillExpress offers a unique blend of technical expertise, commercial flexibility, and client-focused service, making us a preferred choice for third-party Artemether & Lumefantrine manufacturing.

Benefits of partnering with us include:

  • Proven track record of WHO-compliant antimalarial production
  • Affordable pricing without compromising on quality
  • Complete regulatory documentation support
  • Timely delivery and scalable production capacity
  • Customizable packaging and private labeling
  • Experience serving NGOs, hospitals, government tenders, and aid agencies

Whether your goal is to serve public health initiatives, enter competitive tenders, or grow your brand in high-demand malaria treatment markets, BluepillExpress is your trusted manufacturing partner.

Commitment to Public Health and Sustainability

BluepillExpress is more than a manufacturing company—we are partners in public health. By producing affordable and high-quality Artemether & Lumefantrine, we contribute to the global fight against malaria, especially in underserved and high-risk regions.

Our manufacturing practices are also aligned with sustainability and corporate social responsibility (CSR) goals:

  • Efficient use of raw materials and energy resources
  • Safe disposal of pharmaceutical waste
  • Compliance with environmental regulations
  • Employment and training of local talent in our manufacturing zones

We aim to be not only a commercial partner but also a socially responsible contributor to better global health outcomes.

Conclusion

BluepillExpress stands at the forefront of third-party manufacturing for Artemether & Lumefantrine, providing clients with an unmatched combination of quality, reliability, and scalability. Our modern infrastructure, scientific excellence, and client-first philosophy ensure that you receive a product that is ready to meet global therapeutic standards and regulatory requirements.

We invite pharmaceutical brands, distributors, government agencies, and healthcare NGOs to collaborate with BluepillExpress for the third-party manufacturing of Artemether & Lumefantrine. Let us help you build a product line that saves lives, supports health systems, and drives sustainable growth.

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