Approved by regulatory bodies worldwide, with expertise in:
Each with their own clean air and water supply to minimize potential for cross contamination. The facility undergoes routine GMP inspections by regulatory bodies worldwide.
The manufacturing facility has been approved by regulatory bodies worldwide, including the U.S. FDA, European Regulatory Authorities, the Israel Ministry of Health, Health Canada, the Australian TGA, KFDA (South Korea), ANVISA (Brazil), South African MOH and others.
Together the teams at BTG are dedicated to meeting and exceeding industry standards required to deliver the highest quality pharmaceuticals to meet our patient’s expectations and healthcare needs. All our supply chain departments work together in a seamless interface from manufacture, quality (QA+QC), along with, product and technology support, project and operational management, to maintenance and engineering to ensure that only the highest quality products leave the facility.