Proguanil Hydrochloride

Proguanil Hydrochloride is a well-known antimalarial drug, primarily used for the prophylaxis and treatment of malaria, particularly caused by Plasmodium falciparum and Plasmodium vivax. As a dihydrofolate reductase inhibitor, Proguanil interferes with the parasite’s ability to synthesize folic acid, a critical component for DNA replication and cell division, thereby halting its life cycle.

Used either as a monotherapy or more commonly in combination with atovaquone, Proguanil has a long-standing history of safety, tolerability, and efficacy. It is especially suitable for travelers, military personnel, and populations in malaria-endemic regions.

At BluepillExpress, we offer advanced third-party manufacturing solutions for Proguanil Hydrochloride, including customized formulations, private labeling, regulatory support, and global export services. Our WHO-GMP-certified manufacturing units, coupled with skilled professionals and stringent quality controls, ensure that each batch of Proguanil meets international quality standards and regulatory requirements.

Therapeutic Applications

Proguanil Hydrochloride is used in various therapeutic settings:

• Prophylaxis of malaria in travelers and at-risk populations
• Treatment of uncomplicated malaria, particularly when used in combination with atovaquone
• Part of combination therapy to overcome chloroquine and pyrimethamine resistance
• Adjunct therapy in multidrug-resistant Plasmodium falciparum infections
• Pediatric use in malaria-prone areas (dose-adjusted)

The drug is valued for its low toxicity, oral bioavailability, and synergistic effects when combined with other antimalarials.

Mechanism of Action

Proguanil Hydrochloride is a biguanide derivative that is metabolized in the liver to its active form, cycloguanil. Cycloguanil inhibits plasmodial dihydrofolate reductase (DHFR), a key enzyme required for folate metabolism, thereby preventing the parasite from synthesizing essential nucleic acids.

Key pharmacological effects:

• Inhibits parasite DNA replication and cell division
• Reduces the development and maturation of asexual erythrocytic forms
• Potentiates the efficacy of atovaquone, reducing resistance development

This dual-phase activity makes Proguanil a valuable agent for both prophylactic and curative purposes.

Available Dosage Forms by BluepillExpress

At BluepillExpress, we manufacture a variety of Proguanil Hydrochloride dosage forms, optimized for therapeutic efficacy, patient compliance, and regulatory compliance.

1. Proguanil Hydrochloride Tablets

• 100 mg
• 200 mg

2. Fixed-Dose Combinations (available on request)

• Atovaquone + Proguanil Hydrochloride (250 mg + 100 mg)
• Chloroquine + Proguanil Hydrochloride combinations for resistant cases
• Pediatric chewable or dispersible tablets available

3. Oral Suspension (custom development available)

• For pediatric and geriatric use
• Flavored, sugar-free, and alcohol-free options

Packaging Options:

• Blister packs (Alu-Alu / PVC-Alu)
• HDPE bottles with childproof caps
• Unit-dose packs for hospital supply
• Travel kit packaging for prophylactic use

All products are developed to meet the USP, BP, IP, or EP specifications, based on client and market requirements.

Manufacturing Infrastructure at BluepillExpress

BluepillExpress operates world-class manufacturing facilities with dedicated sections for antimalarial drug production, allowing for high-volume and contamination-free output.

Key Facility Highlights:

• WHO-GMP, ISO 9001:2015, and HACCP-certified facilities
• Dedicated HVAC systems and cleanroom environments
• Modern equipment for granulation, blending, compression, and coating
• High-speed tablet presses and blister packing lines
• In-house analytical and microbiological laboratories
• Process automation and ERP integration for traceability

Each stage—from procurement of APIs to final packaging—is monitored under standard operating procedures (SOPs) and validated for efficacy, consistency, and regulatory adherence.

Quality Control and Assurance

At BluepillExpress, quality is embedded in every stage of production. Our Quality Assurance (QA) and Quality Control (QC) systems are in line with international pharmacopeial standards and include:

• Raw material and excipient verification
• Identification and assay of Proguanil Hydrochloride and metabolites
• Content uniformity and dissolution profiling
• Microbial limit testing
• Impurity profiling and residual solvent analysis
• Stability testing as per ICH guidelines (Zones III & IV)

We ensure that all batches meet therapeutic potency, safety, and shelf-life stability before they are released for marketing or export.

Customization and Private Labeling

We offer comprehensive private label manufacturing services for pharmaceutical companies seeking to market Proguanil under their own brand. Customization services include:

• Custom dosage strengths or FDCs (Fixed Dose Combinations)
• Brand name and logo creation
• Custom packaging artwork and design
• Blister or bottle configurations for commercial or institutional supply
• Multilingual labeling and leaflets (as per destination country)

Our design and technical team will work with your brand vision to develop market-ready, compliant, and differentiated products.

Regulatory Documentation Support

We provide comprehensive regulatory documentation and support services required for product registration across regulated and semi-regulated markets. Available documents include:

• Certificate of Analysis (COA)
• Certificate of Pharmaceutical Product (COPP)
• Batch Manufacturing Records (BMR)
• Drug Master File (DMF) – upon request
• Method of Analysis (MOA) and validation reports
• Product Development Report (PDR)
• Stability data under ICH conditions
• Dossiers in CTD, eCTD, or ACTD format

Our regulatory affairs team assists clients with health authority responses, labeling compliance, and audits, ensuring smooth market entry.

Export Capability and Global Reach

As a trusted global exporter of antimalarial medications, BluepillExpress is experienced in fulfilling orders for:

• Government procurement agencies
• NGOs and humanitarian missions
• Hospital chains and public health programs
• Private pharmaceutical brands and wholesalers
• UN and WHO distribution networks

Primary export destinations include:

• Africa: Nigeria, Kenya, Tanzania, Ethiopia, Ghana
• Middle East: Iraq, Yemen, Jordan, UAE
• Asia: Myanmar, Philippines, Cambodia, Nepal
• Latin America: Honduras, Bolivia, Dominican Republic
• CIS Countries: Uzbekistan, Armenia, Georgia

We offer flexible shipping terms including FOB, CIF, and DDP, and support documentation such as MSDS, COAs, Free Sale Certificates, and shipping bills for seamless international clearance.

Research and Development Capabilities

Our dedicated R&D department supports formulation development, stability improvement, and combination therapy innovation for antimalarial products.

Specialized R&D Capabilities:

• Pediatric and geriatric-friendly dosage development
• Enhanced bioavailability solutions
• Extended-release or modified-release formats
• Development of FDCs with Atovaquone or Chloroquine
• Support for BE (Bioequivalence) studies and pharmacokinetic profiling
• Compatibility with WHO prequalification requirements (on demand)

We also offer pilot batch production, process scale-up, and technology transfer support to facilitate rapid commercialization.

Shelf Life and Storage

• Standard Shelf Life: 24–36 months
• Recommended Storage: Below 30°C in a dry place, protected from light and moisture
• Packaging is optimized for hot and humid conditions, suitable for Zone III & IV climates
• Tamper-evident and moisture-proof packaging available for all configurations

Stability data for real-time and accelerated conditions is available for all formulations.

Sustainability and Ethical Compliance

At BluepillExpress, we prioritize eco-conscious manufacturing and ethical sourcing:

• Non-toxic solvents and biodegradable excipients
• Effluent treatment and zero-liquid discharge systems
• GMP-compliant waste management
• Fair labor practices and regular employee training
• Support for community malaria awareness programs

Our operations are designed to uphold the highest ethical standards while delivering life-saving medications to the communities that need them most.

Why Choose BluepillExpress for Proguanil Hydrochloride Manufacturing?

• WHO-GMP Certified Infrastructure
• Flexible Manufacturing Quantities
• Full Customization and Private Labeling
• Comprehensive Regulatory and Dossier Support
• Global Export Readiness
• Dedicated Customer and Technical Support Teams
• Reliable Lead Times and Proven Supply Chain Integrity

Whether you’re an established pharmaceutical company or an NGO expanding malaria treatment programs, BluepillExpress offers the manufacturing excellence, flexibility, and reliability you need.

Conclusion

Proguanil Hydrochloride remains a key agent in the global fight against malaria, especially in combination therapies that address drug-resistant strains. With its proven efficacy, safety profile, and suitability for preventive use, Proguanil continues to be a valuable inclusion in both public health initiatives and private treatment protocols.

BluepillExpress is your trusted partner for end-to-end third-party manufacturing of Proguanil Hydrochloride. From formulation and packaging to regulatory support and global logistics, we empower your brand to deliver consistent, effective, and affordable antimalarial solutions to the world.