Quinine Sulphate

Quinine Sulphate is a naturally derived alkaloid extracted from the bark of the cinchona tree and has long been recognized for its potent antimalarial properties. Despite the emergence of modern antimalarial drugs, Quinine Sulphate remains a valuable therapeutic agent for chloroquine-resistant strains of Plasmodium falciparum, and continues to be used for treating malaria, leg cramps, and certain autoimmune disorders.

At BluepillExpress, we offer WHO-GMP-compliant third-party manufacturing of Quinine Sulphate in various strengths and formulations for global pharmaceutical markets. Our advanced infrastructure, stringent quality controls, and regulatory experience enable us to deliver high-quality Quinine Sulphate products suitable for both regulated and emerging markets.

What is Quinine Sulphate?

Quinine Sulphate is an alkaloid-based antimalarial drug known for its blood schizonticidal activity against Plasmodium species. It interrupts parasite DNA replication, leading to parasite death within red blood cells. Quinine is also known for its muscle relaxant and analgesic properties.

Therapeutic Class: Antimalarial, Muscle Relaxant, Antipyretic
Mechanism of Action: Interferes with parasite’s ability to digest hemoglobin; disrupts nucleic acid synthesis
Route of Administration: Oral (tablets/capsules), Injectable (available on request)

Therapeutic Indications

Quinine Sulphate is clinically proven to treat various forms of malaria, particularly when resistance to first-line agents like chloroquine is prevalent. It is also used for its off-label therapeutic benefits.

Primary Indications:

• Treatment of uncomplicated or severe malaria caused by P. falciparum
• Malaria unresponsive to chloroquine and artemisinin-based combinations
• Nocturnal leg cramps (off-label use)
• Autoimmune disorders and lupus-related fevers (adjunctive)
• Babesiosis (alternative use with clindamycin)
• Myotonic conditions (as muscle relaxant in specific settings)

Quinine Sulphate remains especially relevant in rural, tropical, and sub-Saharan regions where drug resistance is common and newer treatments are cost-prohibitive.

Why Choose BluepillExpress?

At BluepillExpress, we deliver end-to-end third-party manufacturing solutions that cater to the global need for quality-assured, affordable, and effective antimalarial therapies like Quinine Sulphate.

Our Distinctive Strengths:

• WHO-GMP, ISO 9001:2015 certified facilities
• Complete adherence to IP/BP/USP/EP quality standards
• Manufacturing capability for both low- and high-dose antimalarial tablets
• Expert formulation and analytical R&D team
• Custom branding and private label options
• Full regulatory documentation for domestic and international markets
• Consistent supply, high production flexibility, and competitive pricing

We maintain high production standards while empowering brands to scale in local and international antimalarial markets.

Available Dosage Forms and Strengths

BluepillExpress manufactures Quinine Sulphate in a variety of standard oral dosage forms tailored to regional therapeutic needs and regulatory guidelines.

Oral Formulations:

• Quinine Sulphate 200 mg Tablets
• Quinine Sulphate 300 mg Tablets
• Quinine Sulphate 600 mg Tablets (for severe malaria cases)

We also offer Quinine Sulphate capsules, syrups, and injectable forms on request or per tender specification.

Product Composition

Each formulation of Quinine Sulphate is manufactured using high-purity API and quality excipients for maximum therapeutic effect and stability.

Example: Quinine Sulphate 300 mg Tablet

• Active Ingredient: Quinine Sulphate IP/BP/USP 300 mg
• Excipients: Microcrystalline cellulose, magnesium stearate, starch, colloidal silicon dioxide, talc, and film-coating materials
• Optional Coating: Film or sugar coating to improve swallowability and shelf life

We also offer uncoated, scored, and rapid-release variants based on market demand.

Manufacturing Process

Our manufacturing of Quinine Sulphate tablets is executed under strict pharmaceutical GMP protocols with an emphasis on dose uniformity, purity, and microbial safety.

Key Manufacturing Steps:

1. Raw Material Procurement & Testing – Verification of active and inactive ingredients
2. Granulation Process – Wet or dry granulation based on formulation requirement
3. Blending & Lubrication – Homogeneous mixing for dose consistency
4. Compression – Tablet formation under controlled humidity
5. Coating (if required) – Film/sugar coating to mask bitterness and improve stability
6. Blister/Bottle Packaging – In tamper-proof and moisture-resistant packs
7. Quality Checks – Assay, dissolution, disintegration, and microbial testing

The production areas are segregated, air-controlled, and continuously monitored for environmental and product integrity.

Quality Assurance and Testing

At BluepillExpress, every batch of Quinine Sulphate undergoes rigorous quality control testing to comply with international standards.

Quality Control Parameters:

• Assay and Content Uniformity
• Dissolution and Disintegration Time
• Loss on Drying and Moisture Content
• Residual Solvent Analysis
• Impurity and Heavy Metal Testing
• Microbial Load Testing
• Stability Testing (Accelerated and Real-Time)

Each shipment is accompanied by a Certificate of Analysis (COA) and complies with full documentation requirements.

Packaging Options

We provide tailor-made packaging solutions for Quinine Sulphate in alignment with regulatory standards and client branding.

Packaging Formats:

• Blister Packs: PVC-Alu, Alu-Alu
• HDPE Bottles: For bulk and institutional supply
• Cartons: Printed mono cartons with product information leaflet
• Labeling: Multilingual labels, QR codes, serializations available
• Unit Packs: For government and NGO tenders

We support private label, OEM, and white label packaging for branded marketing or institutional supply chains.

Regulatory and Technical Documentation

BluepillExpress offers complete technical and regulatory documentation support for product registration and international trade compliance.

Documents Available:

• WHO-GMP Certificate
• Certificate of Pharmaceutical Product (COPP)
• Product Dossier in CTD or ACTD format
• Certificate of Analysis (COA)
• Stability Data (Zone II, III, IVa, IVb)
• Batch Manufacturing Record (BMR)
• Master Formula Record (MFR)
• Method of Analysis (MOA)
• Free Sale Certificate
• Material Safety Data Sheet (MSDS)

We support product registrations with authorities including PPB (Kenya), NDA (Uganda), FMHACA (Ethiopia), SFDA (Saudi Arabia), and INVIMA (Colombia), among others.

Export Capabilities

BluepillExpress is an experienced global exporter of antimalarial medicines, and we ship Quinine Sulphate to countries where malaria remains a public health challenge.

Key Export Regions:

• Africa: Nigeria, Ghana, Kenya, Tanzania, Cameroon
• Asia-Pacific: Bangladesh, Sri Lanka, Myanmar, Philippines
• Middle East: Yemen, Iraq, Syria
• CIS Nations: Uzbekistan, Kyrgyzstan, Georgia
• Latin America & Caribbean: Bolivia, Haiti, Guyana, Dominican Republic
• Pacific Islands & Territories: Papua New Guinea, Fiji

We handle full-scale air and sea logistics, customs documentation, and ensure product safety during transit.

Ideal Clients for Quinine Sulphate Manufacturing

Our third-party manufacturing services for Quinine Sulphate are ideal for:

• Generic pharmaceutical companies
• Government tender suppliers and NGOs
• Public health-focused medicine distributors
• Emergency relief and humanitarian organizations
• Private label healthcare brands
• Institutional buyers and healthcare trusts
• Pharmaceutical exporters and international traders

Why Partner with BluepillExpress?

• WHO-GMP certified manufacturing units
• High-quality, cost-effective Quinine Sulphate products
• Strict quality control and documentation
• Full regulatory support for global registrations
• Flexible production capacities (small and large batches)
• Branding, labeling, and packaging customization
• Global export logistics and client servicing