BIO 2019: Biologics GMP Issued to Axis Biotec Subsidiary Silvestre Labs

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Axis Biotec is a private pharmaceutical holding company, specialized in biotechnology, focusing on commercially viable products and services resulting from its investments in R&D. (Photo: Business Wire)

The ANVISA, Brazil’s National Health Surveillance Agency - Good Manufacturing Practices (GMP) certification qualifies Axis Biotec manufacturing facility in Rio de Janeiro to register, import, manufacture 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.

About Axis Biotec

Axis Biotec is a private pharmaceutical holding company, specialized in biotechnology, with focus on deploying commercially viable products and services resulting from its investments in R&D. It owns and controls Silvestre Labs, a pharmaceutical company, Cryopraxis, the largest Brazilian stem cell blood bank, Plantpraxis, a R&D company focused in vegetal expression of biologics and Cellpraxis, a R&D company focused in regenerative medicine. Since 2013, Axis Biotec has been involved in technology transfer and nationalization projects that would enable the manufacturing of biologic drugs in Brazil. Through partnerships with originators of biologic drugs and the thoughtful integration of innovation management and execution capabilities, Axis is strategically positioned to provide top quality products and services.

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