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Quality Certifications & Compliance

WHO-GMP certified manufacturing with comprehensive international quality standards and complete regulatory documentation for global market access.

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Certifications

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Countries Registered

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Primary Standards

WHO-GMP, ISO 9001

Documentation

Complete Bundle

Audit Status

Current Valid

Support

Regulatory Team

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Quality Excellence
Global Standards

WHO-GMP Certification

World Health Organization Good Manufacturing Practices certification with current validity and regular audits.

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ISO 9001:2015

Quality management system certification ensuring consistent product quality and continuous improvement.

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Regulatory Dossiers

Complete CTD/eCTD dossiers for major markets including USFDA, EMA, and other regulatory authorities.

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Need Quality Documentation?

Our regulatory team provides complete certification packages and documentation support for market registration and compliance.

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Quality Excellence

Comprehensive Quality Compliance

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100% Compliance Rate

Our fluconazole manufacturing facilities maintain the highest international quality standards with regular audits, certifications, and comprehensive documentation for global regulatory compliance.

Global Standards

Compliance with USP, EP, JP, BP, and other international pharmacopeias ensuring product quality worldwide.

Regular Audits

Scheduled internal and external audits maintaining continuous improvement and regulatory compliance.

Complete Documentation

Full regulatory documentation including certificates of analysis, manufacturing records, and stability data.

Certification Types

Our Quality Certifications

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WHO-GMP Certification

Current WHO-GMP certification with comprehensive compliance for pharmaceutical manufacturing.

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ISO 9001:2015

Quality management system certification ensuring consistent quality and customer satisfaction.

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Regulatory Documentation

Complete regulatory dossiers and documentation for global market registration.

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Quality Testing

Comprehensive quality testing protocols and validation studies for product assurance.

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