Since our first FDA inspection around the year 2000, ChemCon has maintained a long-standing and successful cooperation with the U.S. Food and Drug Administration. Over the years, our GMP-certified facilities have consistently met the highest regulatory expectations for the manufacture of active pharmaceutical ingredients (APIs).
The most recent FDA inspection was conducted within the framework of international regulatory cooperation, allowing the FDA to rely on inspection outcomes from trusted European authorities. This reflects a high level of confidence in ChemCon’s GMP systems and quality standards.
Through close collaboration with pharmaceutical companies in the United States, ChemCon APIs have helped save and improve the lives of patients, particularly in the area of rare and orphan diseases, where dependable access to high-quality APIs is essential.
In these therapeutic areas, supply security is critical. Any disruption in API availability can directly impact patients who often have limited or no alternative treatment options. ChemCon ensures reliable supply through:
- Robust GMP systems aligned with FDA and EU requirements
- Decades of successful inspections and regulatory experience
- Dedicated equipment and strong contamination control
- Reliable manufacturing of small to mid-scale GMP quantities
An FDA-recognized GMP facility remains the gold standard for pharmaceutical manufacturing. ChemCon’s inspection history provides partners with confidence in quality, compliance, and long-term supply security.
