Primaquine is an essential antimalarial medication used primarily for the radical cure and relapse prevention of malaria caused by Plasmodium vivax and Plasmodium ovale. It plays a critical role in the global fight against malaria by targeting liver-stage hypnozoites, which are responsible for relapses. Primaquine is also effective in the gametocytocidal treatment of Plasmodium falciparum, making it vital in blocking malaria transmission.
As a WHO-listed essential medicine, Primaquine is widely used in endemic regions and supported by national malaria control programs and NGOs. With increasing emphasis on malaria eradication, the demand for high-quality, cost-effective, and WHO-compliant Primaquine formulations is rising worldwide.
BluepillExpress offers comprehensive third-party manufacturing services for Primaquine tablets. Our services are geared towards pharmaceutical brands, government health agencies, non-profit organizations, and procurement agencies seeking reliable production and global export of Primaquine.
About BluepillExpress
BluepillExpress is a leading Indian pharmaceutical manufacturing and export company that provides customized third-party manufacturing solutions across a wide range of therapeutic areas. We specialize in contract manufacturing, private labeling, bulk supply, and regulatory support for essential and life-saving medications.
With fully certified manufacturing facilities and export capabilities in over 50 countries, we offer:
- WHO-GMP certified production
- ISO 9001:2015 quality assurance
- IP, BP, and USP-compliant formulations
- CTD/ACTD dossier support
- Multilingual labeling and international packaging options
Our mission is to empower global healthcare providers by delivering quality pharmaceuticals at affordable prices, on time, and with full regulatory compliance.
Pharmacological Classification
- Generic Name: Primaquine Phosphate
- Therapeutic Class: Antimalarial
- Pharmacological Class: 8-Aminoquinoline
- Primary Indications: Radical cure of P. vivax and P. ovale malaria; Gametocytocidal therapy for P. falciparum
- Dosage Form: Oral Tablets
Mechanism of Action
Primaquine acts on the exoerythrocytic (hepatic) stages of the malaria parasite. Its mechanism involves:
- Disrupting mitochondrial electron transport in the parasite
- Interfering with parasite DNA synthesis
- Destroying dormant hypnozoites in the liver, preventing relapse
- Killing gametocytes in P. falciparum, thereby reducing transmission
Unlike other antimalarials that act on the blood stage, Primaquine is unique in its ability to offer a radical cure, ensuring complete parasite clearance.
Clinical Uses and Indications
Primaquine is widely recommended for the treatment and prevention of various forms of malaria, including:
- Radical cure of P. vivax and P. ovale malaria
- Blocking transmission of P. falciparum by killing gametocytes
- Prophylactic use in travelers to endemic regions (in specific guidelines)
- Malaria elimination campaigns by governments and NGOs
Primaquine is generally administered after or alongside blood-stage antimalarials like chloroquine or artemisinin-based combinations.
Dosage Forms and Strengths Offered by BluepillExpress
BluepillExpress manufactures high-quality Primaquine tablets in accordance with WHO, IP, and USP standards.
Standard Dosage Strengths:
- Primaquine Phosphate 7.5 mg Tablets
- Primaquine Phosphate 15 mg Tablets
These are offered as:
- Uncoated or film-coated tablets
- Single or bulk strip packaging
- Customized blister or bottle formats (10×10, 1×10, 100s, etc.)
Flavor masking, sugar-free options (for pediatric or diabetic populations), and customized color coding are available on request.
Manufacturing Infrastructure
Our Primaquine tablets are produced in our WHO-GMP and ISO 9001:2015 certified facilities, which are built to support large-scale international pharmaceutical production.
Key Facility Features:
- Fully air-controlled cleanrooms (Class 100K, 10K)
- High-speed tablet compression and coating machines
- Water purification systems (RO + DM + UV)
- Automated granulation and drying equipment
- Real-time monitoring systems for humidity, temperature, and contamination control
- Complete in-house formulation development and R&D lab
With validated equipment and SOP-based workflows, we ensure consistency, accuracy, and safety in every batch.
Quality Control and Quality Assurance
At BluepillExpress, we follow a rigorous multi-level quality control system to guarantee product quality, stability, and compliance.
QC Testing Includes:
- API and excipient testing
- Uniformity of dosage units
- Hardness, friability, and disintegration tests
- Content assay (UV/HPLC-based)
- Microbial load and contamination checks
- Stability testing under ICH conditions
All manufacturing steps are documented with:
- Batch Manufacturing Records (BMR)
- Certificate of Analysis (COA)
- Validation protocols and reports
- Stability data and packaging integrity results
Our QA protocols ensure every product meets or exceeds client, regulatory, and international health standards.
Packaging and Labeling Options
We offer customizable packaging solutions for Primaquine, suitable for branded marketing or government/institutional supply.
Packaging Formats:
- Blister packs: PVC/Alu and Alu/Alu
- HDPE bottles: With desiccants and child-safe caps
- Outer cartons: With multilingual labels and inserts
- Bulk packs: For institutional tenders and emergency stockpiles
Labeling Support:
- Languages: English, French, Spanish, Arabic, Swahili, Russian
- Artwork design, logo incorporation, barcode placement
- Patient information leaflets (PIL) compliant with regional guidelines
Our packaging options are climate-stable, tamper-proof, and export-ready, ensuring long shelf life and ease of use.
Regulatory & Documentation Support
We offer complete regulatory support for product registration and tender applications. Our regulatory affairs team is experienced with the requirements of:
- WHO
- Ministry of Health (MoH) of importing countries
- NAFDAC (Nigeria), PPB (Kenya), TMDA (Tanzania), FMHACA (Ethiopia), and others
- UNICEF and NGO procurement protocols
Documents Provided:
- WHO-GMP Certificate
- Certificate of Pharmaceutical Product (COPP)
- Certificate of Origin
- Free Sale Certificate
- Certificate of Analysis
- CTD/ACTD format dossiers
- Product specification sheets and MSDS
- Label mock-ups and artwork files
We assist in fast-track registration and e-tender documentation, ensuring no delays in market entry or supply chain processes.
Private Label and Third-Party Manufacturing Services
Whether you are a new entrant or an established brand, BluepillExpress provides a seamless, end-to-end third-party manufacturing solution for Primaquine.
Services Include:
- Custom branding and logo placement
- Full confidentiality and IP protection
- Formulation customization (based on country guidelines)
- Sample batch development for trial or registration
- Flexible Minimum Order Quantities (MOQs)
- Competitive pricing and bulk manufacturing capacity
We work with distributors, NGOs, health ministries, and global aid agencies to provide mission-critical antimalarial products under ethical, scalable, and GMP-certified operations.
Global Export Reach
BluepillExpress exports to over 50 countries and actively participates in public health tenders for malaria treatment programs.
Primary Export Regions:
- Africa: Nigeria, Ghana, Kenya, Ethiopia, Uganda, Sudan
- Asia: India, Myanmar, Bangladesh, Cambodia, Nepal
- Middle East: Yemen, Jordan, Iraq, Lebanon
- Latin America: Dominican Republic, Haiti, Bolivia
- Pacific Islands: Papua New Guinea, Solomon Islands
Our products are used in malaria elimination campaigns, humanitarian missions, and by ministries of health, armed forces, and UN-backed programs.
Sustainability and Ethical Manufacturing
BluepillExpress is committed to sustainable operations and ethical business practices:
- GMP-compliant waste management
- Energy-efficient manufacturing processes
- No child labor, gender-neutral employment practices
- Ethical sourcing of raw materials
- Social responsibility through support of healthcare initiatives
We align with the United Nations Sustainable Development Goals (SDGs) for health and environmental responsibility.
How to Start Third-Party Manufacturing of Primaquine with BluepillExpress
Step 1: Share Your Requirements
Specify strength (7.5 mg or 15 mg), packaging type, quantity, and country of registration.
Step 2: Get a Quotation
Receive a tailored commercial offer including timeline, MOQ, and documentation.
Step 3: Sample Development
If required, we produce samples for testing, approval, or dossier filing.
Step 4: Commercial Production
GMP-compliant manufacturing begins upon approval and advance confirmation.
Step 5: Packaging & Branding
Your custom branding, labeling, and artwork is applied with regulatory-compliant inserts.
Step 6: Global Dispatch
We ship your order with full regulatory and commercial documentation.
Conclusion
Primaquine plays an indispensable role in the global fight against malaria. As one of the few drugs that targets liver-stage hypnozoites and gametocytes, it is crucial for breaking the transmission cycle and achieving radical cure of the disease.
BluepillExpress brings deep pharmaceutical expertise, certified facilities, and a global logistics network to offer reliable and scalable third-party manufacturing for Primaquine. Our commitment to quality, compliance, and public health impact makes us a trusted partner for healthcare providers, governments, and NGOs alike.