Brazilian National Sanitary Surveillance Agency (ANVISA) has certified Next Breath as a Centre for Pharmaceutical Equivalence (EQFAR). As a result, Next Breath is now authorised to conduct Pharmaceutical Equivalence studies for Brazil. ANVISA performed a week-long comprehensive audit of Next Breath’s quality systems in November 2013.
The audit focused on ensuring that all quality systems, analytical capabilities, regulatory expertise and statistical expertise meet ANVISA’s rigorous standard for becoming an approved centre for pharmaceutical equivalence. The successful audit approves Next Breath for performing in vitro pharmaceutical equivalence and submission of nasal sprays, dry powder inhalers (DPIs), and Pressurized 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 Centre for Pharmaceutical Equivalence certification makes Next Breath the only laboratory outside Brazil certified to perform in vitro pharmaceutical equivalence testing for use in the Brazilian market.
Julie Suman, President, Next Breath said, “Next Breath has been committed to working with ANVISA and our Brazilian partners for many years. Recognition as an EQFAR laboratory allows us to bring our scientific expertise and know-how to advance generic drug approvals. We are pleased with this certification.”
EP News Bureau– Mumbai