WHO-GMP Manufacturing Facility

State-of-the-art pharmaceutical manufacturing plant in Sarigam GIDC, Vapi-Daman Zone, Gujarat with EU-GMP, WHO-GMP, and PICS certifications

WHO-GMP Certified EU-GMP Compliant PICS Approved ISO 9001:2018
Monthly Production Capacity:
Tablets: 120 million
Capsules: 40 million
Dry Powders: 36,000 kg
Effervescent: 20 million
Oral Jelly: 60 million
Creams/Ointments: 40 million
Taj Pharma WHO-GMP Manufacturing Facility Sarigam GIDC

WHO-GMP Certified Manufacturing Excellence

State-of-the-art pharmaceutical manufacturing facility in Sarigam GIDC, Vapi-Daman Zone

Taj Pharma India Ltd. - Global Pharmaceutical Leader

Globally recognized pharmaceutical manufacturer headquartered near Vapi, Gujarat, operating from a state-of-the-art facility in Sarigam GIDC. Committed to quality and innovation with WHO-GMP, ISO 9001:2018, and forthcoming EU-GMP and PICS approvals.

Advanced Manufacturing Infrastructure

Strategically located in India's pharmaceutical hub with cutting-edge technology

Taj Pharma WHO-GMP Certified Manufacturing Facility Sarigam GIDC Vapi

Taj Pharma Manufacturing Plant - WHO-GMP Certified Facility in Sarigam GIDC, Vapi, Gujarat

Strategic Location

Facility: Sarigam GIDC

Zone: Vapi-Daman Zone, Gujarat

Hub: India's generics pharmaceutical center

Advantage: Cost-effective raw materials & skilled expertise

Quality Certifications

WHO-GMP: Certified manufacturing facility

ISO 9001:2018: Quality management system

EU-GMP: Forthcoming approval

PICS: Pending certification

Product Portfolio

Tablets: Multiple dosage forms

Capsules: Softgel & hard capsules

Injections: Sterile formulations

Topicals: Creams, ointments & jellies

Key Pharmaceutical Products

Extensive product portfolio covering diverse therapeutic categories

Cardiovascular

Amlodipine and Valsartan Tablets

Emergency Medicine

Adrenaline Injection

Respiratory

Montelukast Tablets

Hormonal Therapy

Progesterone Softgel Capsules

Global Distribution

Products distributed worldwide, making quality healthcare accessible to all with competitive pricing and high-quality solutions

Production Process

Streamlined manufacturing workflow for Mebendazole Tablets 500mg

1
Raw Material Testing

All incoming raw materials undergo rigorous quality testing including identity, purity, and potency analysis before approval for use.

2
Granulation

Wet granulation process using high-shear granulators ensures uniform particle size distribution and optimal flow properties.

3
Compression

High-speed rotary tablet compressors with 30+ stations ensure consistent tablet weight, hardness, and disintegration properties.

4
Inspection

Automated vision inspection systems detect defects, ensuring only perfect tablets proceed to packaging.

5
Packaging

Automated blister packaging and cartoning in controlled environment to maintain product integrity.

6
Final Testing

Comprehensive quality testing of finished products including assay, dissolution, and stability testing.

Quality Control Laboratory

State-of-the-art analytical testing and quality assurance

Analytical Equipment

  • HPLC Systems: Waters & Agilent for assay and impurity profiling
  • GC Systems: For residual solvent analysis
  • UV-Vis Spectrophotometers: For dissolution testing
  • FTIR Spectrometers: For raw material identification
  • Atomic Absorption: For heavy metal testing
  • Microbial Testing: Sterility and endotoxin testing

Testing Protocols

  • Raw Materials: Identity, purity, assay, microbial limits
  • In-Process: Granule properties, tablet hardness, weight variation
  • Finished Products: Assay, dissolution, content uniformity
  • Stability: ICH stability studies under various conditions
  • Microbial: Sterility testing, bacterial endotoxin testing
  • Environmental: Clean room monitoring and validation

Clean Room Facilities

Controlled environment for pharmaceutical manufacturing

Clean Room Classification

Grade 100,000 (ISO 8)

Raw material storage and preparation areas

Grade 10,000 (ISO 7)

Granulation and compression areas

Grade 1,000 (ISO 6)

Product filling and packaging areas

Grade 100 (ISO 5)

Aseptic processing and critical areas

Environmental Controls
  • HEPA filtration systems for air purification
  • Positive pressure differentials between zones
  • Temperature and humidity control (20-25°C, 30-65% RH)
  • Continuous particulate monitoring
  • Air change rates: 15-60 air changes per hour
  • UV sterilization for surface decontamination

Quality Assurance System

Comprehensive quality management system

Documentation

  • Standard Operating Procedures (SOPs)
  • Batch Manufacturing Records (BMRs)
  • Quality Control Reports
  • Stability Study Protocols
  • Validation Master Plans
  • Change Control Procedures

Process Validation

  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Process Validation Protocols
  • Cleaning Validation Studies
  • Analytical Method Validation

Continuous Improvement

  • KPI Monitoring and Analysis
  • Root Cause Analysis (RCA)
  • CAPA Implementation
  • Management Review Meetings
  • Internal Audit Programs
  • External Regulatory Audits

Regulatory Compliance

Global regulatory standards and approvals

Global Regulatory Approvals

🇺🇸 FDA (USA)

Current Good Manufacturing Practices (cGMP) compliance

🇪🇺 EMA (Europe)

EudraLex Volume 4 GMP guidelines compliance

🌍 WHO

WHO-GMP certification and prequalification

🇬🇧 MHRA (UK)

Orange Guide GMP standards compliance

🇦🇺 TGA (Australia)

Australian GMP Code compliance

🇯🇵 PMDA (Japan)

PMDA GMP standards compliance

Compliance Highlights
  • Regular audits by regulatory authorities
  • Maintained inspection readiness status
  • Zero major observations in last 5 years
  • Continuous training programs for staff
  • Up-to-date regulatory documentation

Technology & Innovation

Advanced manufacturing technologies and continuous innovation

Automation Systems

  • SCADA systems for process control
  • Automated material handling systems
  • Real-time monitoring and control
  • Digital batch record systems
  • Automated quality inspection
  • Process analytical technology (PAT)

Data Management

  • Electronic Batch Records (EBR)
  • LIMS for laboratory data management
  • QMS for quality management
  • Real-time data analytics
  • Predictive maintenance systems
  • Cloud-based data storage

Environmental Sustainability

Green manufacturing and environmental responsibility

Sustainable Manufacturing Practices

Waste Management

Comprehensive waste segregation and recycling programs with 85% waste reduction

Water Conservation

Advanced water treatment and recycling systems with 60% water reuse

Energy Efficiency

Solar power integration and energy-efficient equipment with 30% energy reduction

Emission Control

Advanced emission control systems meeting international environmental standards

Environmental Certifications
  • ISO 14001:2015 Environmental Management
  • Zero Liquid Discharge (ZLD) certification
  • Green Building certification for facility
  • Carbon footprint monitoring and reduction

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