We are dedicated to providing high-quality pharmaceutical products and empowering our franchise partners

Our Commitment

Quality Standards That Never Compromise

Leiha Pharmaceuticals quality control laboratory

At Leiha Pharmaceuticals, our quality assurance protocols exceed international standards, ensuring every tablet, capsule, and injection meets our exacting specifications. Our “Zero Defect” philosophy has resulted in 12 consecutive years of flawless regulatory audits across all facilities.

Certifications & Compliance

  • WHO-GMP certified manufacturing facilities with Class 100,000 clean rooms
  • ISO 9001:2015 certified quality management system with real-time monitoring
  • 21 CFR Part 11 compliant electronic record-keeping systems
  • Regular audits by USFDA, EMA, TGA, and MHRA inspectors

Our 360° Quality Assurance Process

1

Raw Material Vetting

Every batch of active pharmaceutical ingredients undergoes identity testing via HPLC and GC, microbiological analysis, and residual solvent screening

2

In-Process Excellence

Real-time monitoring includes weight variation checks every 15 minutes and disintegration time verification

3

Release Testing

Final products must pass assay (95-105% potency), dissolution profile matching, and container closure integrity testing

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