Amodiaquine

Amodiaquine is a well-established antimalarial agent widely used in the treatment and prevention of Plasmodium falciparum malaria, especially in endemic regions of Africa, Asia, and Latin America. Recognized for its cost-effectiveness, broad-spectrum efficacy, and long half-life, Amodiaquine is used alone and in combination with other drugs such as Artesunate for Artemisinin-based Combination Therapies (ACTs).

At BluepillExpress, we are proud to offer WHO-GMP certified third-party manufacturing of Amodiaquine in compliance with international pharmacopoeial standards. As a global pharmaceutical manufacturer and exporter, BluepillExpress supports government tenders, NGOs, institutional buyers, and pharmaceutical companies seeking reliable, scalable, and high-quality antimalarial production services.

Product Overview

Product Name: Amodiaquine
Therapeutic Category: Antimalarial
Available Strengths and Forms:

• Amodiaquine Hydrochloride Tablets:
  • 150 mg
  • 200 mg
  • 300 mg (Base equivalent)
• Amodiaquine + Artesunate Tablets:
  • 150 mg + 50 mg (commonly used fixed-dose combination)
• Pediatric Dispersible Tablets (on request)
• Syrup Formulation for children (customizable)

Route of Administration: Oral
Packaging Options:

• Blister packs (Alu-Alu or PVC-Alu) – 3, 6, or 10 tablet packs
• HDPE bottles for bulk supply or institutional programs
• Customized packaging for public health tenders and private label brands

Pharmacological Classification

Amodiaquine is a 4-aminoquinoline compound, chemically related to chloroquine, and acts as a blood schizonticide. It is active against asexual erythrocytic stages of Plasmodium species, particularly P. falciparum and P. vivax, and shows efficacy in chloroquine-resistant strains.

It is classified as a WHO-recommended antimalarial when used in combination therapy, especially in seasonal malaria chemoprevention (SMC) programs and intermittent preventive treatment (IPT) in children and pregnant women.

Mechanism of Action

Amodiaquine inhibits heme polymerase, an enzyme used by Plasmodium parasites to detoxify free heme (a by-product of hemoglobin digestion). By preventing the conversion of toxic heme into hemozoin, the drug causes accumulation of toxic heme within the parasite, leading to its death.

This mechanism effectively stops the replication of Plasmodium in the red blood cells, rapidly reducing parasitemia and associated clinical symptoms.

Indications

Amodiaquine is indicated for the treatment and prevention of:

• Uncomplicated P. falciparum malaria (particularly in regions with chloroquine resistance)
• Combination therapy with Artesunate as per WHO guidelines
• Seasonal Malaria Chemoprevention (SMC) for children aged 3–59 months
• Intermittent Preventive Treatment in Pregnancy (IPTp)
• Post-treatment prophylaxis due to its long half-life

Off-label and investigational uses also include treatment of autoimmune diseases (e.g., lupus) and potential antiviral applications.

Why Choose BluepillExpress for Amodiaquine Manufacturing?

1. WHO-GMP Certified Infrastructure

Our manufacturing facilities are certified under WHO-GMP, ISO 9001:2015, and Schedule M, ensuring compliance with global production standards. We maintain dedicated antimalarial production zones with:

• Stainless steel granulation and compression equipment
• Blister and bottle packaging lines with automated inspection
• Air-controlled cleanroom environments with Class 100,000 standards
• Water systems compliant with IP, USP, and WHO guidelines

We have the capacity to meet large-volume government tenders and international procurement standards.

2. Formulation Versatility

Our R&D team supports multiple dosage forms and strengths, including:

• Dispersible tablets for pediatric use
• Syrups and oral suspensions for infants and children
• Combination therapies like Amodiaquine + Artesunate FDCs
• Stability-enhanced formulations for tropical climates

We also offer non-bitter, flavored pediatric formulations, enhancing compliance in children during seasonal prevention programs.

Quality Control and Assurance

Quality is a cornerstone of BluepillExpress’ production philosophy. Our in-house QC labs ensure:

• Accurate assay of Amodiaquine hydrochloride and base content
• Uniformity of weight and content
• Dissolution and disintegration profiling
• Residual solvent and impurity limits
• Heavy metals and microbiological testing
• Accelerated and long-term stability testing as per ICH guidelines

All QC data undergoes independent review by the Quality Assurance department before batch release.

Regulatory and Documentation Support

We provide complete documentation and technical support to assist clients in registering Amodiaquine products in local and international markets.

Documentation includes:

• Certificate of Analysis (CoA)
• Batch Manufacturing Record (BMR)
• GMP Certificate
• Free Sale Certificate
• CTD or ACTD Dossiers
• WHO-type Product Information File
• Stability Data and Product Specifications
• Method of Analysis (MoA)
• Material Safety Data Sheet (MSDS)

We have experience in product registrations in Africa, Southeast Asia, CIS, and Latin America, and support dossier submissions for government and NGO tenders.

Private Label and Packaging Solutions

BluepillExpress offers full custom branding, packaging, and private label solutions, including:

• Client logo and brand color incorporation
• Multilingual labeling and inserts (e.g., French, Arabic, Swahili)
• Flexible blister and bottle options
• Weather-resistant packaging for tropical distribution
• QR coding, barcoding, and serialization for track-and-trace requirements
• Eco-conscious materials for NGO or institutional orders

Our packaging is designed to withstand high humidity and temperature, making it suitable for tropical deployment.

Export and Global Logistics

With established export links to over 35 countries, BluepillExpress ensures seamless international delivery through:

• Air and sea freight logistics, with cold chain support if required
• Pre-shipment inspection by SGS, Bureau Veritas, or Intertek (on request)
• Coordination with Ministry of Health requirements
• Government tender supply documentation
• Integration with third-party warehousing or in-country supply chain partners

We support government-funded programs, NGO health initiatives, and private sector clients with scalable, dependable, and compliant exports.

Manufacturing Workflow

Our third-party and contract manufacturing process is designed for transparency and efficiency:

1. Product Scope & Agreement
   • Client specifies formulation, dosage, packaging, and target country
   • NDA and quotation shared; timelines and compliance discussed
2. Product Development (if required)
   • R&D batches created and evaluated for bioequivalence and stability
3. Regulatory and Artwork Submission
   • Label design, CoAs, and technical files provided
4. Commercial Production
   • Raw material sourcing, granulation, tablet compression, and coating
5. Quality Assurance and Documentation
   • Batch testing and release, followed by preparation of export documents
6. Packaging and Dispatch
   • Branded or institutional packaging, with freight booking and dispatch

Average Turnaround Time: 30–45 working days from final artwork and regulatory approval

Client Profiles Served

Our Amodiaquine manufacturing services cater to:

• Pharmaceutical marketing companies launching generic or branded lines
• Government tenders and Ministry of Health procurement programs
• International NGOs and public health organizations
• Distributors and wholesalers in malaria-endemic regions
• Pediatric and maternal health program suppliers

We offer flexibility in MOQs, especially for pilot programs or donor-funded initiatives.

Why BluepillExpress Is Your Ideal Partner

• WHO-GMP certified with international quality benchmarks
• High-volume manufacturing capacity for seasonal and emergency supply
• Full-spectrum regulatory and dossier support
• Custom dosage forms and climate-stable formulations
• Track record in NGO, tender, and global supply chain partnerships
• Transparent communication, fair pricing, and strong client servicing

Conclusion

Amodiaquine remains a pivotal drug in the fight against malaria, especially in vulnerable populations like children, pregnant women, and underserved communities. With the growing focus on preventive malaria programs and global efforts to reduce disease burden, the need for quality, scalable, and cost-effective manufacturing solutions has never been greater.

BluepillExpress delivers world-class contract manufacturing services for Amodiaquine, built on a foundation of quality, compliance, and client satisfaction. Whether you’re supplying government tenders, launching private label brands, or supporting NGO-led interventions, our team is committed to helping you deliver life-saving antimalarial products efficiently and reliably.