WHO-GMP & EU-GMP Approvals

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Dedicated Anthelmintic Manufacturing Excellence

Taj Pharma's dedicated anthelmintic manufacturing block has been audited and approved by national and international regulators, maintaining complete compliance with WHO-GMP and EU-GMP standards. Our state-of-the-art facility in Vapi, Gujarat, represents the pinnacle of pharmaceutical manufacturing excellence for Fenbendazole tablets.

  • WHO-GMP certified manufacturing facility with annual surveillance audits
  • EU-GMP compliance for European market access and export
  • Complete Site Master File (SMF) for regulatory submissions
  • Dedicated anthelmintic production block with segregated operations

Certification Excellence

  • WHO-GMP Certificate: Valid until 2026 with annual compliance
  • EU-GMP Certificate: Approved for European distribution
  • ISO 9001:2015: Quality management system certification
  • Facility Size: 50,000 sq. ft. dedicated anthelmintic block
📥 Download WHO-GMP Certificate ✉️ Request Site Master File

WHO-GMP & EU-GMP Compliance Features

Our manufacturing facility exceeds international quality standards with comprehensive compliance documentation and validation.

Facility Certification

  • WHO-GMP Certificate (Valid: 2024-2026)
  • EU-GMP Approval for European Markets
  • ISO 9001:2015 Quality Management
  • ISO 14001:2015 Environmental Management
  • OHSAS 18001:2007 Occupational Health

Dedicated Manufacturing Block

  • 50,000 sq. ft. segregated facility
  • Dedicated anthelmintic production lines
  • ISO Class 7 (Class 10,000) cleanrooms
  • Separate API and finished product areas
  • Controlled temperature and humidity

Complete Documentation

  • Site Master File (SMF) ready
  • Equipment qualification reports
  • Process validation documentation
  • Cleaning validation protocols
  • Stability study data packages

International Regulatory Approvals

Our WHO-GMP certification is recognized by regulatory authorities worldwide, enabling smooth market access.

Global Recognition

  • WHO Prequalification: Eligible for WHO procurement programs
  • UN Agencies: Approved for UNICEF, UNFPA procurement
  • Global Fund: Accepted for Global Fund programs
  • World Bank: Approved for World Bank projects
  • 200+ Countries: Recognition across international markets

Quality Assurance

  • Annual Audits: Regular surveillance audits
  • Continuous Improvement: Ongoing quality enhancement
  • Training Programs: Staff qualification and training
  • Change Control: Controlled change management
  • Deviation Management: Systematic deviation handling

Request Complete WHO-GMP Documentation Package

Get comprehensive WHO-GMP certification documents, Site Master File, and compliance reports for your regulatory submissions.

📋 Request WHO-GMP Package 📚 All Regulatory Documents

For prescription and export purposes only. Use under medical supervision. Not intended for self-medication. Information for educational purposes. Export subject to local regulations.

© 2026 Fenbendazole Pharma. All Rights Reserved.
For prescription and export purposes only. Not intended for self-medication. Export subject to local regulations.