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Your Trusted Generics Medicine Supplier
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Mumbai, India
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Global Presence & Distribution
Mefloquine Tablets USP 250mg by Taj Pharma - Trusted presence across global markets with comprehensive regulatory compliance and distribution networks.
Export Countries & Markets
Africa
East Africa
- Kenya
- Tanzania
- Uganda
- Rwanda
- Burundi
- Ethiopia
- Somalia
West Africa
- Nigeria
- Ghana
- Ivory Coast
- Senegal
- Mali
- Guinea
- Liberia
Southern Africa
- South Africa
- Zimbabwe
- Zambia
- Malawi
- Mozambique
- Botswana
- Namibia
Asia
Southeast Asia
- Thailand
- Myanmar
- Cambodia
- Vietnam
- Laos
- Philippines
- Indonesia
- Malaysia
South Asia
- India
- Pakistan
- Bangladesh
- Sri Lanka
- Nepal
- Bhutan
- Maldives
Americas
South America
- Brazil
- Peru
- Bolivia
- Colombia
- Ecuador
- Venezuela
- Guyana
- Suriname
Central America & Caribbean
- Mexico
- Guatemala
- Honduras
- Nicaragua
- Costa Rica
- Panama
- Haiti
- Dominican Republic
Pacific Islands
Melanesia
- Papua New Guinea
- Solomon Islands
- Vanuatu
- New Caledonia
- Fiji
Other Pacific
- Samoa
- Tonga
- Kiribati
- Tuvalu
- Marshall Islands
Registration Status
Regulatory Approvals
WHO Prequalification
Listed in WHO Prequalification of Medicines Programme (PQP)
ApprovedUS FDA
Approved under ANDA pathway for generic mefloquine
ApprovedEuropean Medicines Agency (EMA)
Approved through decentralized procedure
ApprovedNational Regulatory Authorities
Registered in over 50 countries worldwide
Multiple ApprovalsRegistration Process
1. Dossier Preparation
Complete CTD format dossier with all required documentation
2. Regulatory Submission
Submission to national regulatory authorities with local requirements
3. Review & Approval
Regulatory review process with timeline monitoring
4. Post-Approval Compliance
Ongoing compliance with pharmacovigilance and quality requirements
Available for Dossier Submission
Complete Registration Dossier
Comprehensive dossier available for registration in new markets:
- Module 1: Administrative Information
- Module 2: Quality Overall Summary
- Module 3: Quality Documentation
- Module 4: Non-clinical Studies
- Module 5: Clinical Studies
Dossier Features:
- CTD format compliant
- eCTD ready for electronic submission
- Country-specific adaptations available
- Local language translations provided
- Regulatory consultation support
Submission Support
Comprehensive support for dossier submission:
- Regulatory strategy development
- Country-specific requirement analysis
- Submission timeline management
- Regulatory authority liaison
- Post-submission follow-up
Private Label & Contract Manufacturing
Contract Manufacturing Services
Available Services:
- Private Label Manufacturing: Production under customer brand
- Contract Manufacturing: Large-scale production for distributors
- Technology Transfer: Complete process transfer capabilities
- Custom Formulations: Tailored solutions for specific markets
Manufacturing Capabilities:
- WHO-GMP certified facilities
- Annual capacity: 500 million tablets
- Multiple packaging options
- Quality assurance at every stage
- Regulatory compliance support
Partnership Opportunities
Partnership Models:
- Distribution Partnerships: Exclusive and non-exclusive arrangements
- Licensing Agreements: Technology and brand licensing
- Joint Ventures: Strategic partnerships for market entry
- Agency Agreements: Local representation and registration support
Partner Benefits:
- Competitive pricing structure
- Marketing and regulatory support
- Training and technical assistance
- Supply chain reliability
- Quality assurance guarantee
Quality & Compliance Standards
Manufacturing Standards
- WHO-GMP Certified Manufacturing Facility
- ISO 9001:2015 Quality Management System
- ISO 14001:2015 Environmental Management
- OHSAS 18001:2007 Occupational Health & Safety
- US FDA Current Good Manufacturing Practices (cGMP)
- EU Good Manufacturing Practices
Quality Assurance
- In-process quality controls
- Finished product testing
- Stability testing programs
- Batch-to-batch consistency
- Traceability systems
- Continuous improvement programs
International Compliance
- ICH Guidelines compliance
- International Pharmacopeial standards
- Country-specific regulatory requirements
- Export quality certifications
- Pharmacovigilance compliance
- Environmental compliance