In March 2025, Ampharco U.S.A marked a milestone in its development when its manufacturing facility was officially granted the EU-GMP (European Good Manufacturing Practice) certificate. This is one of the strictest standards in the pharmaceutical industry, widely recognized in Europe and other developed countries.
Achieving EU-GMP certification not only demonstrates modern manufacturing capacity but also underscores Ampharco U.S.A’s strong commitment to enhancing product quality for patients. The company ensures strict compliance with raw material input controls, cross-contamination prevention, air-water-waste management, and production equipment standards in accordance with EU-GMP. This guarantees that all products released to the market meet the highest safety and efficacy standards, providing a stronger foundation for protecting patient health.
Ampharco U.S.A’s quality management system includes:
- Quality risk management: Predicting and minimizing errors across the product value chain.
- Continuous validation and calibration: Ensuring all equipment and processes remain stable and consistent.
- Environmental monitoring and regular inspections: Real-time control of cross-contamination, air, water, and pressure.
- Traceability: Automatic recording, retrieval, and verification of production data.
- Ongoing training system: Ensuring all staff are proficient in international standards.
Ampharco U.S.A’s products are now available across nearly all provinces and cities in Vietnam, delivering tangible healthcare benefits to the population. From major urban centers to even rural communities, people can readily access medicines that meet European quality standards—safe, effective, and at a far more affordable cost than imported drugs.
With EU-GMP technology and processes, the company is also steadily entering demanding markets such as Japan, Europe, and the U.S., raising Vietnam’s pharmaceutical standards globally.