Next Breath certified as Centre for Pharmaceutical Equivalence in Brazil
Authorised to perform in vitro testing for generic pulmonary and nasal drug products and devices in the country
US contract research organisation Next Breath, part of the Aptar Group, has been certified by the Brazilian National Sanitary Surveillance Agency (ANVISA) as a Centre for Pharmaceutical Equivalence (EQFAR).
This means the Baltimore, Maryland-based CRO is now authorised to conduct pharmaceutical equivalence studies and submit nasal sprays, dry powder inhalers (DPIs), and pressurised metered dose inhalers (pMDIs) to the Brazilian authorities.
Only ANVISA certified laboratories are authorised to perform in vitro pharmaceutical equivalence testing for generic applications in the Brazilian market. The EQFAR certification makes Next Breath the only laboratory outside Brazil qualified to perform such tests in the country.