The ANVISA, Brazil's National Health Surveillance Agency has qualified Axis Biotec manufacturing facility in Rio de Janeiro to register, import, manufacture (GMP) and also store and distribute biologic drugs in Brazil.
Brazil's GMP regulations, which closely resemble the internationally recognized standards for USA and EU, require biologic drug manufacturers to have a robust quality system for the manufacture, packaging, labeling and storage of such products.
“Axis is very pleased with the successful completion of the ANVISA inspection and GMP certification of our Rio de Janeiro manufacturing facility. Our strict adherence to GMP and our quality systems allow Axis to provide our clients with a high-quality product,” said Tatiana Lima, Axis Technical Director. “Our certification from ANVISA, represents an important milestone for our strategy to nationalize the manufacturing of biologic drugs in Brazil, enabling broader access to the population and providing better care for patients,” said Guilherme Goldberg, Axis CEO.
“We will continue to increase our commitment to quality and patient safety, aligned with our mission,” said Eduardo Cruz, Axis Advisor and shareholder.