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As infectious diseases such as malaria and protozoal infections continue to pose a significant global health threat, effective, broad-spectrum antiprotozoal drugs like Mepacrine Hydrochloride play an essential role in therapeutic management. Known historically as Quinacrine, Mepacrine Hydrochloride is a synthetic acridine derivative with diverse pharmacological applications ranging from antimalarial and antiprotozoal activity to anti-inflammatory and dermatological use.
BluepillExpress is a leading third-party pharmaceutical manufacturer, offering customized and scalable production solutions for Mepacrine Hydrochloride. Our WHO-GMP certified manufacturing facilities, comprehensive regulatory support, and international export experience allow us to deliver superior-quality Mepacrine formulations tailored to meet regional health needs and regulatory standards. With a strong commitment to innovation, compliance, and product integrity, BluepillExpress is positioned as a global manufacturing partner for high-quality niche therapeutics.
About Mepacrine Hydrochloride
Mepacrine Hydrochloride (Quinacrine) is a synthetic acridine derivative originally developed as an antimalarial drug. It demonstrates broad activity against protozoal parasites, including those responsible for giardiasis, lupus-related inflammation, and tapeworm infestations. It also possesses anti-inflammatory, anthelmintic, and immunomodulatory properties, which have made it relevant in various clinical applications even beyond infectious diseases.
Mechanism of Action:
Mepacrine intercalates into DNA and inhibits parasite replication by disrupting transcription and enzyme activity. In autoimmune conditions, it interferes with antigen processing and modulates immune cell activity, providing symptomatic relief.
Primary Therapeutic Applications:
- Malaria (as prophylaxis or treatment adjunct)
- Giardiasis (intestinal protozoal infection)
- Lupus erythematosus (cutaneous and systemic)
- Rheumatoid arthritis (adjunct therapy)
- Tapeworm infestations (alternative or supplementary use)
- Discoid lupus (topical and systemic treatment)
- Cutaneous leishmaniasis
- Adjuvant use in viral or autoimmune disorders (under research)
Though no longer used as a first-line antimalarial due to drug resistance and newer alternatives, Mepacrine continues to be prescribed in niche, underserved therapeutic areas, especially in developing nations and for dermatological autoimmune disorders.
Why Choose BluepillExpress for Mepacrine Hydrochloride Manufacturing?
1. WHO-GMP Certified Manufacturing Facilities
Our facilities meet global quality standards such as WHO-GMP, ISO 9001:2015, and cGMP compliance, allowing us to produce high-quality antiprotozoal formulations in various strengths and dosage forms.
2. Flexible Formulation Options
We manufacture Mepacrine Hydrochloride in multiple dosage forms to cater to varying medical requirements and patient preferences:
- Mepacrine Tablets: 100 mg
- Mepacrine Hydrochloride Capsules: 100 mg (on request)
- Mepacrine Powder (API): Available for bulk supply or extemporaneous compounding
- Topical formulation options (for research or custom orders)
Formulations are manufactured under IP, BP, USP, or EP grades based on the export destination and client requirements.
3. Complete Regulatory and Documentation Support
We provide all necessary documentation to support product registration, export clearance, and compliance:
- Certificate of Pharmaceutical Product (CoPP)
- Certificate of Analysis (CoA)
- Batch Manufacturing Record (BMR)
- Method of Analysis (MOA)
- Stability data (Zone II and IV)
- CTD/eCTD dossiers for semi-regulated and regulated markets
Technical Product Specifications
| Product Name | Mepacrine Hydrochloride (Quinacrine) |
|---|---|
| Dosage Form | Oral Tablets / Capsules |
| Strength Available | 100 mg (standard); others on request |
| Pharmacopoeial Grade | IP / BP / USP / EP |
| Route of Administration | Oral |
| Packaging Options | Blister packs, strip packs, bottles |
| Shelf Life | 24 to 36 months |
| Storage Conditions | Store below 25°C; protect from moisture and light |
Our production is supported by stringent in-process controls, validated manufacturing procedures, and packaging integrity checks to ensure product stability and efficacy throughout the supply chain.
Therapeutic Applications
1. Antiprotozoal Activity
Mepacrine is effective in treating Giardia lamblia infections, commonly encountered in developing regions due to poor water sanitation. It acts by disrupting DNA synthesis in protozoa.
2. Malaria Treatment (Historical Use)
Although superseded by chloroquine and artemisinin-based therapies, Mepacrine still serves a role in malaria prophylaxis and resistant strains in specific geographies.
3. Cutaneous and Systemic Lupus Erythematosus (CLE/SLE)
It acts as an immunomodulator to alleviate skin rashes and joint inflammation, making it a useful second-line or adjunct treatment for lupus patients unresponsive to hydroxychloroquine.
4. Autoimmune and Dermatological Disorders
Used in rheumatoid arthritis, discoid lupus, and other chronic skin diseases, Mepacrine’s anti-inflammatory effects help control symptoms and reduce flares.
5. Helminthic Infections
In cases of tapeworm infestations, Mepacrine may be used in combination with other anti-parasitics to enhance therapeutic outcomes.
Manufacturing Process Overview
Our manufacturing process for Mepacrine Hydrochloride follows GMP-compliant and validated procedures:
- Dispensing of Raw Materials – Weighing of active and excipient materials under cleanroom environments
- Blending – Achieving uniform distribution of API
- Granulation (wet or dry) – Controlled particle sizing and binding
- Compression or Encapsulation – High-speed machines ensure dosage accuracy
- Coating (if applicable) – For stability, ease of swallowing, and reduced bitterness
- Primary and Secondary Packaging – Blister or bottle filling, with tamper-evident seals
- Quality Control Testing – Comprehensive analytical and microbial analysis
Our equipment includes:
- Rapid Mixer Granulators (RMG)
- Compression machines
- Blister and strip packaging lines
- Capsule filling machines
- Stability chambers (Zone I to Zone IV)
Quality Assurance and Quality Control
We follow international QA/QC protocols to maintain the highest standards in every batch:
Quality Control Parameters:
- Assay (Active content)
- Disintegration and dissolution
- Uniformity of weight and thickness
- Microbial limit tests
- Residual solvents and impurities
- UV stability and moisture control
Each shipment is accompanied by:
- Certificate of Analysis (CoA)
- Stability data
- Product specification sheet
- Pharmacopoeial compliance documents
- Batch Manufacturing Record (BMR)
All analytical methods are validated as per ICH guidelines, and full traceability is maintained across the supply chain.
Packaging and Labeling Options
We provide custom packaging options to suit both retail and institutional clients:
Primary Packaging:
- Blister packs (Alu-Alu or PVC-Alu)
- Strip packs in foil pouches
- HDPE bottles with moisture-absorbing closures
Secondary Packaging:
- Printed mono-cartons
- Multilingual patient inserts
- Tamper-evident shrink wrapping
We support private labeling, regulatory-specific artwork, and serialization/barcoding for tracking and compliance with international regulations.
Global Export Capabilities
BluepillExpress is a trusted exporter of Mepacrine Hydrochloride formulations to over 40 countries across:
- Africa: Nigeria, Kenya, Uganda, Ghana
- Asia: Bangladesh, Myanmar, Cambodia
- Latin America: Bolivia, Honduras, Peru
- CIS & Eastern Europe
- Middle East
Our export-ready products are supported by:
- Product Registration Dossiers
- GMP and FSC certificates
- COAs and COO documents
- Support for customs clearance and shipping documentation
- Flexible Incoterms (FOB, CIF, CFR, DDP)
We also serve tenders, NGOs, public health agencies, and emergency medical supply programs.
Client Segments Served
Our third-party manufacturing solutions for Mepacrine Hydrochloride are ideal for:
- Generic pharmaceutical brands
- Hospitals and institutional medicine suppliers
- Public health procurement bodies
- International humanitarian organizations
- Distributors in tropical disease control programs
- Online pharmacies and telehealth brands
We support both large-volume production and small MOQ runs, offering scalability to meet your brand’s growth needs.
Research and Development Capabilities
BluepillExpress supports clients through innovative product development and technical expertise in:
- Formulating Mepacrine in combination with anti-parasitic or anti-inflammatory agents
- Taste-masked tablets and coated capsules
- Pediatric dosing solutions
- Customized topical options for research use
- Process scale-up and tech transfer
Our R&D team collaborates closely with clients to meet specific formulation goals and market demands.
Sustainability and Compliance
We ensure environmentally responsible manufacturing through:
- Zero Liquid Discharge (ZLD) systems
- Non-hazardous waste handling
- Energy-efficient production practices
- Ethical sourcing of raw materials
- Compliance with labor and safety laws
We align our practices with global sustainability frameworks and maintain full transparency during audits and inspections.
Confidentiality and Business Integrity
Client confidentiality and data protection are integral to our operations:
- Legally binding Non-Disclosure Agreements (NDAs)
- Exclusive manufacturing contracts (on request)
- IP protection for custom formulations
- Transparent and traceable documentation
- On-time delivery with post-manufacturing support
Our focus is to become your trusted long-term manufacturing partner in niche therapeutic segments.
Conclusion
Mepacrine Hydrochloride (Quinacrine) continues to hold medical relevance across tropical medicine, dermatology, and autoimmune disease treatment. Its multi-indication efficacy and safety profile make it an ideal candidate for public health programs, institutional supply, and targeted therapeutic markets.
BluepillExpress is your ideal partner for third-party manufacturing of Mepacrine Hydrochloride, offering technical precision, regulatory compliance, and market agility. Whether you’re entering a new therapeutic segment or scaling an established brand, we ensure seamless contract manufacturing tailored to your needs.
