IndiaMart
FIEO
Malaria remains a major public health concern in many parts of the world, especially in sub-Saharan Africa, Southeast Asia, and Latin America. Resistance to older antimalarial medications has made combination therapies essential in effective treatment strategies. One of the most potent and WHO-endorsed Artemisinin-based Combination Therapies (ACTs) is Pyronaridine + Artesunate, known for its high efficacy against Plasmodium falciparum, including strains resistant to other antimalarials.
BluepillExpress is a globally trusted pharmaceutical manufacturing and export company specializing in high-quality antimalarial therapies. We provide third-party manufacturing services for Pyronaridine + Artesunate combinations tailored for governments, NGOs, healthcare institutions, and private label companies worldwide. Our WHO-GMP certified facilities ensure safety, efficacy, and international compliance.
Product Overview
Generic Name: Pyronaridine Tetraphosphate + Artesunate
Therapeutic Category: Antimalarial Combination Therapy
Pharmacological Class: Artemisinin-Based Combination Therapy (ACT)
Available Dosage Forms:
- Tablets (Film-coated, immediate-release)
- Pediatric dispersible tablets (on request)
Common Strengths Available:
- Pyronaridine Tetraphosphate 180 mg + Artesunate 60 mg (Adult Dose)
- Pyronaridine Tetraphosphate 60 mg + Artesunate 20 mg (Pediatric Dose)
Packaging Options:
- Blister packs (1×3, 1×6, 1×9 tablets)
- Strip packs for institutional supply
- Mono-cartons with multilingual inserts
- Child-resistant and anti-counterfeit packaging available
Pharmacopoeial Compliance: WHO PQ / IP / BP / USP (as per regulatory requirement)
Mechanism of Action
Pyronaridine:
A Mannich base antimalarial with potent schizonticidal activity against blood-stage Plasmodium falciparum. It interferes with hemozoin formation, leading to toxic accumulation of free heme within the parasite.
Artesunate:
A semi-synthetic derivative of artemisinin that generates free radicals when activated in the parasite’s food vacuole. This rapidly damages parasite proteins and membranes, leading to quick parasite clearance.
Synergistic Activity:
The combination of Pyronaridine and Artesunate offers complementary action:
- Artesunate acts quickly, reducing parasitemia within 24–48 hours
- Pyronaridine sustains the antimalarial effect, preventing recrudescence
This synergy ensures high cure rates, reduced gametocyte carriage, and resistance suppression.
Indications
Pyronaridine + Artesunate is indicated for the treatment of:
- Acute uncomplicated malaria due to Plasmodium falciparum, including multi-drug resistant strains
- Co-infections involving P. vivax (when accompanied by appropriate follow-up therapy)
- Treatment of malaria in adults, adolescents, and children (based on body weight)
- Use in public health programs and government malaria control campaigns
Dosage and Administration
Adult Dosage (≥20 kg body weight):
- Pyronaridine 180 mg + Artesunate 60 mg: One tablet once daily for 3 consecutive days
Pediatric Dosage (5 kg to <20 kg):
- Based on weight bands; dispersible tablets available for children
| Weight Range | Number of Tablets per Day | Duration |
|---|---|---|
| 5–10 kg | 1 pediatric tablet | 3 days |
| 10–20 kg | 2 pediatric tablets | 3 days |
| 20–40 kg | 1 adult tablet | 3 days |
| >40 kg | 2 adult tablets | 3 days |
Administration Guidelines:
- Should be taken with food to enhance absorption
- Strict adherence to 3-day regimen essential for full therapeutic benefit
- Not recommended for severe malaria (parenteral treatment preferred)
- Follow-up may be needed for P. vivax relapse prevention (with primaquine)
Pharmacokinetics
- Artesunate:
- Rapid absorption; converted to active dihydroartemisinin (DHA)
- Half-life: ~1 hour
- Peak effect within 1–2 hours
- Pyronaridine:
- Long half-life (~13–17 days), providing sustained activity
- Slowly absorbed; peak levels in 2–4 hours
- Lipophilic and highly protein-bound
This pharmacokinetic profile enables both rapid parasite clearance and long-term protection against recrudescence.
Advantages of Pyronaridine + Artesunate Combination
- High cure rate (>95%) even in drug-resistant malaria
- Short-course regimen: Only 3 days of once-daily dosing
- Improved adherence compared to older ACTs
- Favorable safety profile with minimal adverse effects
- WHO-endorsed combination for national malaria programs
- Low gametocyte carriage reduces transmission potential
Why Choose BluepillExpress for Manufacturing?
1. WHO-GMP Certified Production Units
We manufacture under strict GMP protocols, ensuring pharmaceutical excellence:
- Controlled-environment tablet manufacturing zones
- High-speed granulation, compression, and coating machinery
- Cleanroom packaging and microbial control compliance
- Separate production lines for antimalarial ACTs
2. Regulatory Documentation and Support
We provide complete regulatory support for product registration, including:
- Certificate of Pharmaceutical Product (COPP)
- Free Sale Certificate (FSC)
- WHO-type Certificate of Analysis (COA)
- Bioequivalence data (if required)
- Stability studies under ICH conditions
- CTD/ACTD dossiers for MOH approvals
3. Tailored Packaging and Private Labeling
We support:
- National malaria program packaging specifications
- QR codes, serialization, and anti-counterfeit measures
- Multilingual inserts (French, English, Arabic, Spanish)
- Customized artwork and branding for institutional or private markets
4. Global Export and Supply Chain Expertise
BluepillExpress supplies Pyronaridine + Artesunate to:
- Africa: Nigeria, DR Congo, Ethiopia, Ghana, Uganda
- Asia: Myanmar, Cambodia, India, Bangladesh
- Middle East: Iraq, Yemen, Sudan
- CIS and Latin America: Uzbekistan, Bolivia, Guatemala
Our efficient logistics partners ensure timely delivery for both bulk and branded shipments.
Quality Control and Assurance
All batches undergo rigorous in-house and third-party testing:
- Active Ingredient Assay (Pyronaridine and Artesunate)
- Dissolution Profile for consistent bioavailability
- Microbial Testing for contamination-free assurance
- Hardness, Friability, and Disintegration tests
- Stability Studies under climatic zones I–IV
- Packaging integrity and labeling accuracy checks
Our quality systems comply with IP, USP, BP, and WHO standards.
Third-Party Manufacturing Workflow at BluepillExpress
Step 1: Consultation and Product Finalization
Dosage, packaging, documentation, and market needs are discussed.
Step 2: Sample and Artwork Approval
Pilot batch and packaging samples developed and approved by client.
Step 3: Production and Quality Testing
Bulk production begins in GMP facilities, monitored with in-process QC checks.
Step 4: Packaging and Dispatch
Packed, labeled, and shipped with all necessary documentation.
Step 5: After-Sales Regulatory Support
Support provided for MOH queries, re-registration, and product variations.
Target Market and Clients
- Government Tenders and Public Health Institutions
- NGOs and Global Health Programs (e.g., The Global Fund, UNICEF, USAID)
- Private-label Antimalarial Brands
- Hospital Chains and Pharmacy Distributors
- Exporters and Aid Agencies Serving Malaria-Endemic Regions
Our Pyronaridine + Artesunate combination aligns with public health objectives and provides a cost-effective yet premium solution for malaria control.
Global Market Demand
- The global antimalarial drugs market is expected to cross USD 1 billion by 2028.
- ACTs like Pyronaridine + Artesunate are being adopted in more countries due to their superior cure rates.
- National Malaria Control Programs (NMCPs) increasingly prefer WHO-prequalified fixed-dose ACTs.
- BluepillExpress is strategically positioned to fulfill this demand through scalable, compliant, and affordable third-party manufacturing.
Conclusion
Pyronaridine + Artesunate offers a powerful, fast-acting, and safe antimalarial combination for the treatment of uncomplicated malaria. With increasing global demand for effective ACTs, having a reliable manufacturing partner is critical for success in institutional and commercial markets.
BluepillExpress is committed to supporting global health with quality-assured, affordable antimalarial solutions. Our third-party manufacturing model is built to deliver efficiency, compliance, and innovation — from sample development to final dispatch.
