Certified Quality Is Our Top Concern
We operate our facilities to comply with the highest quality standards, as evidenced by our stellar history in US FDA audits to 21 CFR 210/211, 110/111 and 117 standards. Our focus on quality ensures our customers’ products are not only consistent across every lot we supply, but also meet and exceed the regulatory requirements of global markets.
Our production sites have been audited and certified by organizations with the highest regulatory standards in the world, including:
- The Swedish Medical Products Agency
- Manufacturing Site GMP Approval by German Authorities as (Pharmaceutical Products Act)
- USA FDA audits 21 CFR 210, 211, 110, 111 and 117 standards