Leading Dolutegravir Manufacturer in India
Taj Pharmaceuticals Limited is a WHO-GMP and EU-GMP certified manufacturer of Dolutegravir tablets in India. We specialize in producing high-quality HIV medications including TAPIVIR 50 (50mg) and TAPIVIR DT 10 (10mg dispersible tablets).
With state-of-the-art manufacturing facilities in Vapi, Gujarat, we maintain the highest standards of quality, safety, and efficacy in all our products. Our commitment to excellence has made us one of the most trusted Dolutegravir manufacturers in India and across international markets.
We combine cutting-edge technology with rigorous quality control processes to ensure every batch of Dolutegravir tablets meets or exceeds international pharmaceutical standards.
State-of-the-Art Manufacturing Facilities in Vapi, Gujarat
Our manufacturing facility in Vapi, Gujarat is equipped with the latest pharmaceutical manufacturing technology and infrastructure. We maintain strict adherence to WHO-GMP and EU-GMP standards with continuous investment in facility upgrades and equipment modernization.
Production Unit - Tablet Compression & Packaging
Our production unit features advanced tablet compression machines capable of producing millions of tablets per annum. The facility includes:
- High-speed tablet compression machines with automated controls
- Blister packing machines for secure product packaging
- Bottle filling and capping equipment
- Labeling and serialization systems
- Real-time monitoring and data logging systems
Quality Control Laboratory - Advanced Testing & Analysis
Our state-of-the-art quality control laboratory is equipped with modern analytical instruments for comprehensive batch testing and analysis. The lab includes:
- HPLC (High Performance Liquid Chromatography) systems for assay analysis
- UV-Vis spectrophotometers for quality verification
- Dissolution testing apparatus for bioavailability assessment
- Microbial testing facilities for sterility and contamination checks
- Stability testing chambers for long-term storage evaluation
Manufacturing Excellence & Certifications
Taj Pharma's commitment to manufacturing excellence is reflected in our state-of-the-art facilities, rigorous quality control processes, and multiple international certifications. We maintain the highest standards in pharmaceutical manufacturing to ensure every batch of Dolutegravir tablets meets or exceeds global quality benchmarks.
WHO-GMP Certified
Manufactured in WHO-GMP certified facility with international quality standards. Our facility undergoes regular audits and inspections to maintain certification. We comply with all WHO guidelines for pharmaceutical manufacturing and quality assurance.
EU-GMP Compliant
Compliant with European Good Manufacturing Practice standards. We follow strict protocols for manufacturing, testing, and documentation. Our facility meets the stringent requirements of European pharmaceutical regulations.
Comprehensive Quality Testing
Every batch is tested for quality, potency, and purity before release. We use advanced analytical instruments including HPLC, UV-Vis spectrophotometers, and microbial testing facilities for comprehensive batch analysis and verification.
Export Quality Standards
Meets international standards for export to multiple countries. Our products comply with regulations in over 50 countries worldwide. We maintain strict adherence to international pharmacopeial standards.
Advanced Equipment & Technology
State-of-the-art tablet compression machines, blister packing equipment, and automated quality control systems. Our facility features real-time monitoring and data logging for complete traceability.
Continuous Improvement
Regular facility upgrades, equipment modernization, and process optimization. We invest continuously in research and development to maintain our position as a leading pharmaceutical manufacturer.
50+
Countries Served
100%
Quality Assured
24/7
Quality Monitoring
ISO
Certified
International Certifications & Standards
Taj Pharma holds multiple international certifications that validate our commitment to quality and compliance with global pharmaceutical standards. Our certifications are regularly renewed and audited by international bodies.
WHO-GMP Certificate
World Health Organization Good Manufacturing Practice certification ensures our facility meets the highest international standards for pharmaceutical manufacturing.
- Regular facility audits and inspections
- Compliance with WHO guidelines
- Quality assurance procedures
EU-GMP Certificate
European Good Manufacturing Practice certification demonstrates compliance with stringent European pharmaceutical manufacturing standards.
- European regulatory compliance
- Quality control procedures
- Documentation standards
ISO 9001:2015 Certification
ISO 9001:2015 certification ensures our quality management system meets international standards for consistency and continuous improvement.
- Quality management systems
- Process optimization
- Customer satisfaction focus
ISO 13485:2016 Certification
ISO 13485:2016 certification demonstrates our compliance with medical device quality management system standards.
- Medical device standards
- Risk management
- Product safety assurance
Advanced Manufacturing Process - 6 Step Quality Assurance
Our Dolutegravir manufacturing process is designed to ensure the highest quality standards at every stage. Each step is carefully controlled and monitored to maintain consistency and safety.
Raw Material Selection & Verification
High-purity pharmaceutical-grade raw materials sourced from certified suppliers with complete documentation and testing.
- Certificate of Analysis (CoA)
- Supplier qualification
- Incoming inspection
Formulation & Blending
Precise mixing of active pharmaceutical ingredient (API) and excipients in controlled environment with strict process parameters.
- Controlled temperature & humidity
- Validated mixing equipment
- Batch documentation
Tablet Compression
Advanced compression machines ensure uniform tablet weight, hardness, and friability within strict specifications.
- High-speed compression machines
- Real-time weight monitoring
- Automated quality checks
Quality Testing & Analysis
Comprehensive testing including dissolution, assay, microbial analysis, and stability testing using advanced analytical instruments.
- HPLC assay analysis
- Dissolution testing
- Microbial limits testing
Packaging & Labeling
Blister and bottle packaging with tamper-evident features, proper labeling, and batch serialization for traceability.
- Blister & bottle packing
- Tamper-evident sealing
- Batch serialization
Final Release & Distribution
Final batch testing and quality approval by authorized personnel before distribution to customers and markets.
- Final QA approval
- Storage & handling
- Distribution tracking
Quality Control & Testing Standards
Our quality control department operates with state-of-the-art analytical equipment and highly trained professionals. Every batch of Dolutegravir tablets undergoes rigorous testing to ensure compliance with international pharmaceutical standards.
Advanced Testing Laboratory
Our testing laboratory is equipped with modern analytical instruments for comprehensive batch analysis and quality verification. The lab includes:
Analytical Instruments
- HPLC systems for assay analysis
- UV-Vis spectrophotometers
- Dissolution testing apparatus
- GC-MS for impurity analysis
Testing Parameters
- Content uniformity testing
- Tablet hardness & friability
- Disintegration testing
- Moisture content analysis
Quality Control Team & Procedures
Our dedicated quality control team consists of trained professionals with expertise in pharmaceutical analysis and quality assurance. They ensure every batch meets our stringent specifications.
QC Team Expertise
- Qualified analytical chemists
- Microbiologists for sterility testing
- Quality assurance specialists
- Regulatory compliance officers
Quality Procedures
- In-process quality checks
- End-product testing
- Stability monitoring
- Batch record review
Our Dolutegravir Products
Dolutegravir 50mg (TAPIVIR 50)
Film-Coated Tablets
- Standard strength for adult HIV treatment
- Blister & bottle packaging
- 24 months shelf life
- View Details
Dolutegravir 10mg Dispersible (TAPIVIR DT 10)
Dispersible Tablets
- Ideal for pediatric HIV treatment
- Easy to disperse in water
- 24 months shelf life
- View Details
Manufacturing Capabilities & Production Capacity
Taj Pharma has invested significantly in manufacturing infrastructure to meet the growing demand for high-quality Dolutegravir tablets. Our facility is designed to handle both small and large-scale production orders with consistent quality.
| Capability | Details | Benefits |
|---|---|---|
| Annual Production Capacity | Multi-million tablets per annum | Meets large-scale demand efficiently |
| Tablet Strengths | 50mg and 10mg formulations available | Covers adult and pediatric requirements |
| Packaging Options | Blister packs, bottles, bulk containers | Flexible packaging for different markets |
| Minimum Order Quantity | Flexible - from small to bulk orders | Accommodates all customer sizes |
| Lead Time | 30-45 days for standard orders | Quick turnaround for urgent requirements |
| Quality Standards | USP, BP, IP, EP compliant | International market acceptance |
| Export Capability | Approved for 50+ countries | Global distribution ready |
| Batch Size | Scalable from pilot to commercial | Consistent quality at all scales |
Manufacturing Facility Infrastructure
Our manufacturing facility in Vapi, Gujarat is built to the highest pharmaceutical standards with modern infrastructure and environmental controls.
Facility Features
- Clean Room Facilities: ISO Class 7 clean rooms for manufacturing and packaging
- Environmental Control: Temperature and humidity controlled areas
- HVAC Systems: Advanced air handling and filtration systems
- Water Systems: Purified and WFI (Water for Injection) systems
- Waste Management: Proper disposal systems for pharmaceutical waste
Equipment & Machinery
- Tablet Compression: High-speed rotary tablet presses with automated controls
- Blister Packing: Automatic blister packing machines with sealing
- Bottle Filling: Automated bottle filling and capping equipment
- Labeling: Automatic labeling and serialization systems
- Inspection: Vision inspection systems for quality control
Manufacturing Standards & Equipment Showcase
Advanced Manufacturing Equipment
Our facility is equipped with state-of-the-art pharmaceutical manufacturing equipment designed for precision, consistency, and compliance with international standards.
Equipment Specifications
- Tablet compression capacity: 500,000+ tablets/hour
- Blister packing speed: 200+ blisters/minute
- Bottle filling capacity: 100+ bottles/minute
- Labeling speed: 150+ units/minute
Equipment Features
- Automated process monitoring
- Real-time data logging
- Preventive maintenance programs
- Regular equipment validation
Clean Room Facilities & Environmental Controls
Our clean room facilities maintain strict environmental conditions to ensure product quality and prevent contamination during manufacturing and packaging operations.
Environmental Controls
- ISO Class 7 clean room classification
- Temperature control: ±2°C precision
- Humidity control: 45-55% RH
- Positive pressure maintenance
Air & Water Systems
- HEPA filtration systems
- Purified water generation
- WFI (Water for Injection) system
- Regular air quality monitoring
Quality Metrics & Standards Compliance
Pharmaceutical Standards
- ✓ USP (United States Pharmacopeia)
- ✓ BP (British Pharmacopoeia)
- ✓ IP (Indian Pharmacopoeia)
- ✓ EP (European Pharmacopoeia)
Testing Parameters
- ✓ Assay (HPLC analysis)
- ✓ Dissolution testing
- ✓ Microbial limits
- ✓ Stability testing
Manufacturing Standards & Equipment
Advanced Equipment
State-of-the-art tablet compression and packaging machinery with automated controls
Clean Room Facilities
ISO Class 7 clean rooms for manufacturing and packaging operations
Regulatory Compliance & Approvals
Regulatory Bodies
- ✓ DCGI (Drugs Controller General of India)
- ✓ WHO Prequalification
- ✓ EMA (European Medicines Agency)
- ✓ FDA Compliance
Certifications Held
- ✓ WHO-GMP Certificate
- ✓ EU-GMP Certificate
- ✓ ISO 9001:2015
- ✓ ISO 13485:2016
Why Choose Taj Pharma as Your Dolutegravir Manufacturer?
- Certified Quality: WHO-GMP and EU-GMP certified manufacturing with regular audits
- Competitive Pricing: Best prices for bulk orders with volume discounts
- Pan-India Supply: Reliable distribution across India with efficient logistics
- Export Ready: International quality standards and export compliance
- Bulk Orders: Flexible quantities for distributors
- Technical Support: Complete product documentation and support
Frequently Asked Questions
Get Best Pricing
Contact our sales team for competitive bulk pricing and delivery options.
Contact UsOur Certifications
Quick Facts
- Location: Vapi, Gujarat, India
- Certifications: WHO-GMP, EU-GMP, GMP
- Products: TAPIVIR 50, TAPIVIR DT 10
- Shelf Life: 24 months
- Supply: Pan-India & Export