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ANVISA approval for EMCM facilitates the progress of Leader Biomedical operations in Brazil

AMSTERDAM/SAO PAULO– Leader Biomedical is proud to announce that our manufacturing facility in Nijmegen, European Medical Contract Manufacturing B.V. (EMCM) has received approval by the Brazilian competent authority, Agência Nacional de Vigilância Sanitária (ANVISA). This approval follows the previously announced, ANVISA approval of our facilities in Brazil, Inovações Biológicas Comercial LTDA (Leader Biomedical Brazil), which validated the warehouse facilities and presence of technical staff, ensuring quality standards are met.

These approvals enable our Brazilian venture to fulfill critical milestones and allow Leader Biomedical Brazil to commercialise, distribute and store medical products and devices from class I through IV, which includes all medical products and provide the local region with access to our therapeutic solutions.

“This marks an important step for Leader Biomedical Brazil and EMCM. Since our establishment in 2016, we have been working diligently towards this milestone. Along with the help of our colleagues in the Netherlands, we have achieved the second part of this important certification and now look forward to improving access to our tried and tested bone cements in Brazil and allow for further expansion of our portfolio with orthobiologics and implants”, says Caio Gonçalves, general manager Inovações Biológicas Comercial LTDA

“Brazil is the largest medical device market in Latin America and has set a complex regulatory system as a barrier to entry in order to attest that the quality of the product meets expectations. As ANVISA requires registration request from a local entity, we have been working closely with the team in Brazil to provide all necessary documentation and proof of quality for our Dutch manufacturing facility” explains Arbër Gjunkshi, Regulatory Affairs Manager, Leader Biomedical.

The next and final step is the application with ANVISA for Leader Biomedical Brazil to obtain a legal manufacturing status and product registrations, all of which are scheduled in the coming months.